Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.
Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
Committees established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.
Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.
Works about comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the U.S. and in other countries.
A method of comparing the cost of a program with its expected benefits in dollars (or other currency). The benefit-to-cost ratio is a measure of total return expected per unit of money spent. This analysis generally excludes consideration of factors that are not measured ultimately in economic terms. Cost effectiveness compares alternative ways to achieve a specific set of results.
That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.
Statistical models of the production, distribution, and consumption of goods and services, as well as of financial considerations. For the application of statistics to the testing and quantifying of economic theories MODELS, ECONOMETRIC is available.
The amount that a health care institution or organization pays for its drugs. It is one component of the final price that is charged to the consumer (FEES, PHARMACEUTICAL or PRESCRIPTION FEES).
Application of statistical procedures to analyze specific observed or assumed facts from a particular study.
A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly.
Committees established by professional societies, health facilities, or other institutions to consider decisions that have bioethical implications. The role of these committees may include consultation, education, mediation, and/or review of policies and practices. Committees that consider the ethical dimensions of patient care are ETHICS COMMITTEES, CLINICAL; committees established to protect the welfare of research subjects are ETHICS COMMITTEES, RESEARCH.
Therapy with two or more separate preparations given for a combined effect.
The composition of a committee; the state or status of being a member of a committee.
Groups set up to advise governmental bodies, societies, or other institutions on policy. (Bioethics Thesaurus)
Elements of limited time intervals, contributing to particular results or situations.
Hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects.
The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988)
New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.
Levels within a diagnostic group which are established by various measurement criteria applied to the seriousness of a patient's disorder.
Substances that inhibit or prevent the proliferation of NEOPLASMS.
Committees of professional personnel who have responsibility for determining policies, procedures, and controls related to professional matters in health facilities.
An aspect of personal behavior or lifestyle, environmental exposure, or inborn or inherited characteristic, which, on the basis of epidemiologic evidence, is known to be associated with a health-related condition considered important to prevent.
Hospital or other institutional ethics committees established to consider the ethical dimensions of patient care. Distinguish from ETHICS COMMITTEES, RESEARCH, which are established to monitor the welfare of patients or healthy volunteers participating in research studies.
A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.
Works about controlled studies which are planned and carried out by several cooperating institutions to assess certain variables and outcomes in specific patient populations, for example, a multicenter study of congenital anomalies in children.
A formal process of examination of patient care or research proposals for conformity with ethical standards. The review is usually conducted by an organized clinical or research ethics committee (CLINICAL ETHICS COMMITTEES or RESEARCH ETHICS COMMITTEES), sometimes by a subset of such a committee, an ad hoc group, or an individual ethicist (ETHICISTS).
Works about studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the U.S. and in other countries.
An advisory group composed primarily of staff physicians and the pharmacist which serves as the communication link between the medical staff and the pharmacy department.
Institutional committees established to protect the welfare of animals used in research and education. The 1971 NIH Guide for the Care and Use of Laboratory Animals introduced the policy that institutions using warm-blooded animals in projects supported by NIH grants either be accredited by a recognized professional laboratory animal accrediting body or establish its own committee to evaluate animal care; the Public Health Service adopted a policy in 1979 requiring such committees; and the 1985 amendments to the Animal Welfare Act mandate review and approval of federally funded research with animals by a formally designated Institutional Animal Care and Use Committee (IACUC).
Works about studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.
An approach of practicing medicine with the goal to improve and evaluate patient care. It requires the judicious integration of best research evidence with the patient's values to make decisions about medical care. This method is to help physicians make proper diagnosis, devise best testing plan, choose best treatment and methods of disease prevention, as well as develop guidelines for large groups of patients with the same disease. (from JAMA 296 (9), 2006)
Criteria and standards used for the determination of the appropriateness of the inclusion of patients with specific conditions in proposed treatment plans and the criteria used for the inclusion of subjects in various clinical trials and other research protocols.
Works about clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.
Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.
A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)
Establishment of the level of a quantifiable effect indicative of a biologic process. The evaluation is frequently to detect the degree of toxic or therapeutic effect.
Individual's rights to obtain and use information collected or generated by others.
Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group.
Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease.
Directions or principles presenting current or future rules of policy for assisting health care practitioners in patient care decisions regarding diagnosis, therapy, or related clinical circumstances. The guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by the convening of expert panels. The guidelines form a basis for the evaluation of all aspects of health care and delivery.
Research aimed at assessing the quality and effectiveness of health care as measured by the attainment of a specified end result or outcome. Measures include parameters such as improved health, lowered morbidity or mortality, and improvement of abnormal states (such as elevated blood pressure).
Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.
The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.
A class of statistical procedures for estimating the survival function (function of time, starting with a population 100% well at a given time and providing the percentage of the population still well at later times). The survival analysis is then used for making inferences about the effects of treatments, prognostic factors, exposures, and other covariates on the function.
Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.
Societies whose membership is limited to physicians.
A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)
A quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc., with application chiefly in the areas of research and medicine.
The circulation or wide dispersal of information.
Discontinuance of care received by patient(s) due to reasons other than full recovery from the disease.
Persons who are enrolled in research studies or who are otherwise the subjects of research.
Predetermined sets of questions used to collect data - clinical data, social status, occupational group, etc. The term is often applied to a self-completed survey instrument.
The actual costs of providing services related to the delivery of health care, including the costs of procedures, therapies, and medications. It is differentiated from HEALTH EXPENDITURES, which refers to the amount of money paid for the services, and from fees, which refers to the amount charged, regardless of cost.
Systematic gathering of data for a particular purpose from various sources, including questionnaires, interviews, observation, existing records, and electronic devices. The process is usually preliminary to statistical analysis of the data.
The use of humans as investigational subjects.
Planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the U.S. and in other countries.
Mathematical or statistical procedures used as aids in making a decision. They are frequently used in medical decision-making.
A method in which either the observer(s) or the subject(s) is kept ignorant of the group to which the subjects are assigned.
Tumors or cancer of the human BREAST.
The use of two or more chemicals simultaneously or sequentially in the drug therapy of neoplasms. The drugs need not be in the same dosage form.
A prediction of the probable outcome of a disease based on a individual's condition and the usual course of the disease as seen in similar situations.
Any deviation of results or inferences from the truth, or processes leading to such deviation. Bias can result from several sources: one-sided or systematic variations in measurement from the true value (systematic error); flaws in study design; deviation of inferences, interpretations, or analyses based on flawed data or data collection; etc. There is no sense of prejudice or subjectivity implied in the assessment of bias under these conditions.
Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons.
The relationship between the dose of an administered drug and the response of the organism to the drug.
Research that involves the application of the natural sciences, especially biology and physiology, to medicine.
The return of a sign, symptom, or disease after a remission.
Antibodies from non-human species whose protein sequences have been modified to make them nearly identical with human antibodies. If the constant region and part of the variable region are replaced, they are called humanized. If only the constant region is modified they are called chimeric. INN names for humanized antibodies end in -zumab.
The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic.
Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.
Earlier than planned termination of clinical trials.
A systematic statement of policy rules or principles. Guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by convening expert panels. The text may be cursive or in outline form but is generally a comprehensive guide to problems and approaches in any field of activity. For guidelines in the field of health care and clinical medicine, PRACTICE GUIDELINES AS TOPIC is available.
The worsening of a disease over time. This concept is most often used for chronic and incurable diseases where the stage of the disease is an important determinant of therapy and prognosis.
Drugs that are used to treat RHEUMATOID ARTHRITIS.
Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.
Statistical formulations or analyses which, when applied to data and found to fit the data, are then used to verify the assumptions and parameters used in the analysis. Examples of statistical models are the linear model, binomial model, polynomial model, two-parameter model, etc.
Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
The principles of professional conduct concerning the rights and duties of the physician, relations with patients and fellow practitioners, as well as actions of the physician in patient care and interpersonal relations with patient families.
Disease having a short and relatively severe course.
Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).
The number of units (persons, animals, patients, specified circumstances, etc.) in a population to be studied. The sample size should be big enough to have a high likelihood of detecting a true difference between two groups. (From Wassertheil-Smoller, Biostatistics and Epidemiology, 1990, p95)
Drugs or agents which antagonize or impair any mechanism leading to blood platelet aggregation, whether during the phases of activation and shape change or following the dense-granule release reaction and stimulation of the prostaglandin-thromboxane system.
Services provided by an individual ethicist (ETHICISTS) or an ethics team or committee (ETHICS COMMITTEES, CLINICAL) to address the ethical issues involved in a specific clinical case. The central purpose is to improve the process and outcomes of patients' care by helping to identify, analyze, and resolve ethical problems.
Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work.
Fibrinolysin or agents that convert plasminogen to FIBRINOLYSIN.
Substances that reduce the growth or reproduction of BACTERIA.
Human experimentation that is intended to benefit the subjects on whom it is performed.
Age as a constituent element or influence contributing to the production of a result. It may be applicable to the cause or the effect of a circumstance. It is used with human or animal concepts but should be differentiated from AGING, a physiological process, and TIME FACTORS which refers only to the passage of time.
Antibodies produced by a single clone of cells.
Extensive collections, reputedly complete, of facts and data garnered from material of a specialized subject area and made available for analysis and application. The collection can be automated by various contemporary methods for retrieval. The concept should be differentiated from DATABASES, BIBLIOGRAPHIC which is restricted to collections of bibliographic references.
The treatment of a disease or condition by several different means simultaneously or sequentially. Chemoimmunotherapy, RADIOIMMUNOTHERAPY, chemoradiotherapy, cryochemotherapy, and SALVAGE THERAPY are seen most frequently, but their combinations with each other and surgery are also used.
Agents that prevent clotting.
Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)
The number of new cases of a given disease during a given period in a specified population. It also is used for the rate at which new events occur in a defined population. It is differentiated from PREVALENCE, which refers to all cases, new or old, in the population at a given time.
A subspecialty of internal medicine concerned with the study of neoplasms.
The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.
Statistical models used in survival analysis that assert that the effect of the study factors on the hazard rate in the study population is multiplicative and does not change over time.
A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.
A stochastic process such that the conditional probability distribution for a state at any future instant, given the present state, is unaffected by any additional knowledge of the past history of the system.
An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.
NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).
A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task.
Drugs which have received FDA approval for human testing but have yet to be approved for commercial marketing. This includes drugs used for treatment while they still are undergoing clinical trials (Treatment IND). The main heading includes drugs under investigation in foreign countries.
Patterns of practice related to diagnosis and treatment as especially influenced by cost of the service requested and provided.
Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.
The physiological period following the MENOPAUSE, the permanent cessation of the menstrual life.
Schedule giving optimum times usually for primary and/or secondary immunization.
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
Financial support of research activities.
Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.
The giving of drugs, chemicals, or other substances by mouth.
Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.
A situation in which an individual might benefit personally from official or professional actions. It includes a conflict between a person's private interests and official responsibilities in a position of trust. The term is not restricted to government officials. The concept refers both to actual conflict of interest and the appearance or perception of conflict.
Voluntary cooperation of the patient in following a prescribed regimen.
Recommendations for directing health planning functions and policies. These may be mandated by PL93-641 and issued by the Department of Health and Human Services for use by state and local planning agencies.
"The business or profession of the commercial production and issuance of literature" (Webster's 3d). It includes the publisher, publication processes, editing and editors. Production may be by conventional printing methods or by electronic publishing.
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.
Period after successful treatment in which there is no appearance of the symptoms or effects of the disease.
A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)
The proportion of survivors in a group, e.g., of patients, studied and followed over a period, or the proportion of persons in a specified group alive at the beginning of a time interval who survive to the end of the interval. It is often studied using life table methods.
The interaction of persons or groups of persons representing various nations in the pursuit of a common goal or interest.
Administration of vaccines to stimulate the host's immune response. This includes any preparation intended for active immunological prophylaxis.
Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project.
The use of animals as investigational subjects.
Those individuals engaged in research.
The largest country in North America, comprising 10 provinces and three territories. Its capital is Ottawa.
An operating division of the US Department of Health and Human Services. It is concerned with the overall planning, promoting, and administering of programs pertaining to health and medical research. Until 1995, it was an agency of the United States PUBLIC HEALTH SERVICE.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Scales, questionnaires, tests, and other methods used to assess pain severity and duration in patients or experimental animals to aid in diagnosis, therapy, and physiological studies.
Methods which attempt to express in replicable terms the extent of the neoplasm in the patient.
Patient involvement in the decision-making process in matters pertaining to health.
Component of the NATIONAL INSTITUTES OF HEALTH. Through basic and clinical biomedical research and training, it conducts and supports research with the objective of cancer prevention, early stage identification and elimination. This Institute was established in 1937.
Products in capsule, tablet or liquid form that provide dietary ingredients, and that are intended to be taken by mouth to increase the intake of nutrients. Dietary supplements can include macronutrients, such as proteins, carbohydrates, and fats; and/or MICRONUTRIENTS, such as VITAMINS; MINERALS; and PHYTOCHEMICALS.
Exercise of governmental authority to control conduct.
Computer-based representation of physical systems and phenomena such as chemical processes.
Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. (Webster, 3d ed)
A regimen or plan of physical activities designed and prescribed for specific therapeutic goals. Its purpose is to restore normal musculoskeletal function or to reduce pain caused by diseases or injuries.
Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.
A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.
The process of making a selective intellectual judgment when presented with several complex alternatives consisting of several variables, and usually defining a course of action or an idea.
Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.
An infant during the first month after birth.
Studies comparing two or more treatments or interventions in which the subjects or patients, upon completion of the course of one treatment, are switched to another. In the case of two treatments, A and B, half the subjects are randomly allocated to receive these in the order A, B and half to receive them in the order B, A. A criticism of this design is that effects of the first treatment may carry over into the period when the second is given. (Last, A Dictionary of Epidemiology, 2d ed)
The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.
The teaching or training of patients concerning their own health needs.
Time period from 1901 through 2000 of the common era.
A nonparametric method of compiling LIFE TABLES or survival tables. It combines calculated probabilities of survival and estimates to allow for observations occurring beyond a measurement threshold, which are assumed to occur randomly. Time intervals are defined as ending each time an event occurs and are therefore unequal. (From Last, A Dictionary of Epidemiology, 1995)
The degree to which the individual regards the health care service or product or the manner in which it is delivered by the provider as useful, effective, or beneficial.
The guidelines and policy statements set forth by the editor(s) or editorial board of a publication.
The evaluation by experts of the quality and pertinence of research or research proposals of other experts in the same field. Peer review is used by editors in deciding which submissions warrant publication, by granting agencies to determine which proposals should be funded, and by academic institutions in tenure decisions.
Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.
In screening and diagnostic tests, the probability that a person with a positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a positive test; whereas, the predictive value of a negative test is the probability that the person with a negative test does not have the disease. Predictive value is related to the sensitivity and specificity of the test.
Measurable and quantifiable biological parameters (e.g., specific enzyme concentration, specific hormone concentration, specific gene phenotype distribution in a population, presence of biological substances) which serve as indices for health- and physiology-related assessments, such as disease risk, psychiatric disorders, environmental exposure and its effects, disease diagnosis, metabolic processes, substance abuse, pregnancy, cell line development, epidemiologic studies, etc.
The long-term (minutes to hours) administration of a fluid into the vein through venipuncture, either by letting the fluid flow by gravity or by pumping it.
Tumors or cancer of the LUNG.
General agreement or collective opinion; the judgment arrived at by most of those concerned.
A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable.
A publication issued at stated, more or less regular, intervals.
Suspensions of killed or attenuated microorganisms (bacteria, viruses, fungi, protozoa), antigenic proteins, synthetic constructs, or other bio-molecular derivatives, administered for the prevention, amelioration, or treatment of infectious and other diseases.
Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.
Revealing of information, by oral or written communication.
A direct form of psychotherapy based on the interpretation of situations (cognitive structure of experiences) that determine how an individual feels and behaves. It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and verbal techniques to identify and correct negative thinking that is at the root of the aberrant behavior.
A measure of the quality of health care by assessment of unsuccessful results of management and procedures used in combating disease, in individual cases or series.
Documents describing a medical treatment or research project, including proposed procedures, risks, and alternatives, that are to be signed by an individual, or the individual's proxy, to indicate his/her understanding of the document and a willingness to undergo the treatment or to participate in the research.
Control which is exerted by the more stable organizations of society, such as established institutions and the law. They are ordinarily embodied in definite codes, usually written.
Studies in which subsets of a defined population are identified. These groups may or may not be exposed to factors hypothesized to influence the probability of the occurrence of a particular disease or other outcome. Cohorts are defined populations which, as a whole, are followed in an attempt to determine distinguishing subgroup characteristics.
Any tests that demonstrate the relative efficacy of different chemotherapeutic agents against specific microorganisms (i.e., bacteria, fungi, viruses).
A class of statistical methods applicable to a large set of probability distributions used to test for correlation, location, independence, etc. In most nonparametric statistical tests, the original scores or observations are replaced by another variable containing less information. An important class of nonparametric tests employs the ordinal properties of the data. Another class of tests uses information about whether an observation is above or below some fixed value such as the median, and a third class is based on the frequency of the occurrence of runs in the data. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed, p1284; Corsini, Concise Encyclopedia of Psychology, 1987, p764-5)
Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care. (Dictionary of Health Services Management, 2d ed)
Conformity in fulfilling or following official, recognized, or institutional requirements, guidelines, recommendations, protocols, pathways, or other standards.
An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.
Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues.
The moral and ethical obligations or responsibilities of institutions.
Persons trained in philosophical or theological ethics who work in clinical, research, public policy, or other settings where they bring their expertise to bear on the analysis of ethical dilemmas in policies or cases. (Bioethics Thesaurus)
A malignant neoplasm derived from cells that are capable of forming melanin, which may occur in the skin of any part of the body, in the eye, or, rarely, in the mucous membranes of the genitalia, anus, oral cavity, or other sites. It occurs mostly in adults and may originate de novo or from a pigmented nevus or malignant lentigo. Melanomas frequently metastasize widely, and the regional lymph nodes, liver, lungs, and brain are likely to be involved. The incidence of malignant skin melanomas is rising rapidly in all parts of the world. (Stedman, 25th ed; from Rook et al., Textbook of Dermatology, 4th ed, p2445)
Use of plants or herbs to treat diseases or to alleviate pain.
The quality or state of relating to or affecting two or more nations. (After Merriam-Webster Collegiate Dictionary, 10th ed)
Differences of opinion or disagreements that may arise, for example, between health professionals and patients or their families, or against a political regime.
Treatments which are undergoing clinical trials or for which there is insufficient evidence to determine their effects on health outcomes; coverage for such treatments is often denied by health insurers.
The collective designation of three organizations with common membership: the European Economic Community (Common Market), the European Coal and Steel Community, and the European Atomic Energy Community (Euratom). It was known as the European Community until 1994. It is primarily an economic union with the principal objectives of free movement of goods, capital, and labor. Professional services, social, medical and paramedical, are subsumed under labor. The constituent countries are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, and the United Kingdom. (The World Almanac and Book of Facts 1997, p842)
Studies determining the effectiveness or value of processes, personnel, and equipment, or the material on conducting such studies. For drugs and devices, CLINICAL TRIALS AS TOPIC; DRUG EVALUATION; and DRUG EVALUATION, PRECLINICAL are available.
Professional society representing the field of medicine.
Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.
Studies designed to assess the efficacy of programs. They may include the evaluation of cost-effectiveness, the extent to which objectives are met, or impact.
Clusters of topics that fall within the domain of BIOETHICS, the field of study concerned with value questions that arise in biomedicine and health care delivery.
The application of discoveries generated by laboratory research and preclinical studies to the development of clinical trials and studies in humans. A second area of translational research concerns enhancing the adoption of best practices.
Manipulation of the host's immune system in treatment of disease. It includes both active and passive immunization as well as immunosuppressive therapy to prevent graft rejection.
A specialized agency of the United Nations designed as a coordinating authority on international health work; its aim is to promote the attainment of the highest possible level of health by all peoples.
A set of techniques used when variation in several variables has to be studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.
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The local recurrence of a neoplasm following treatment. It arises from microscopic cells of the original neoplasm that have escaped therapeutic intervention and later become clinically visible at the original site.
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Unilateral transplantation of human primary fetal tissue in four patients with Huntington's disease: NEST-UK safety report ISRCTN no 36485475. (1/43)

OBJECTIVES: Huntington's disease (HD) is an inherited autosomal dominant condition in which there is a CAG repeat expansion in the huntingtin gene of 36 or more. Patients display progressive motor, cognitive, and behavioural deterioration associated with progressive cell loss and atrophy in the striatum. Currently there are no disease modifying treatments and current symptomatic treatments are only partially effective in the early to moderate stages. Neural transplantation is effective in animal models of HD and offers a potential strategy for brain repair in patients. The authors report a safety study of unilateral transplantation of human fetal striatal tissue into the striatum of four patients with HD. SUBJECTS AND METHODS: Stereotaxic placements of cell suspensions of human fetal ganglionic eminence were made unilaterally into the striatum of four patients with early to moderate HD. All patients received immunotherapy with cyclosporin A, azathioprine, and prednisolone for at least six months postoperatively. Patients were assessed for safety of the procedure using magnetic resonance imaging (MRI), regular recording of serum biochemistry and haematology to monitor immunotherapy, and clinical assessment according to the Core Assessment Protocol For Intrastriatal Transplantation in HD (CAPIT-HD). RESULTS: During the six month post-transplantation period, the only adverse events related to the procedure were associated with the immunotherapy. MRI demonstrated tissue at the site of implantation, but there was no sign of tissue overgrowth. Furthermore, there was no evidence that the procedure accelerated the course of the disease. CONCLUSIONS: Unilateral transplantation of human fetal striatal tissue in patients with HD is safe and feasible. Assessment of efficacy will require longer follow up in a larger number of patients.  (+info)

Conducting stroke research with an exception from the requirement for informed consent. (2/43)

BACKGROUND: Obtaining viable informed consent from stroke patients for participation in clinical trials of acute stroke therapies is often problematic because of patients' neurological deficits. Furthermore, obtaining permission from surrogates is often not possible or not legally permissible. SUMMARY OF REVIEW: In 1996 the Food and Drug Administration and Department of Health and Human Services published regulations that allow investigators to conduct emergency research without patient consent under a narrowly defined set of circumstances. We review requirements of these regulations, paying particular attention to how they may be applied in a clinical trial of an acute stroke therapy. CONCLUSIONS: Acute stroke researchers should consider conducting clinical trials with an exception from the informed consent requirement permitted by this law.  (+info)

Items of concern associated with source document verification of clinical trials for new drugs. (3/43)

In the present study, we analyzed concerns of the sponsors of clinical trials regarding source document verification (SDV) procedures performed at the University of Tokyo Hospital during April 1999 and March 2001, with special focus on the differences in description between the source document and case report form (CRF). Of 132 SDV procedures (78 protocols, 496 cases), the sponsors had problematic concerns with 348 cases (70.2%) totalling 693 items, which consisted of description inconsistencies between the source documents and the CRF (41.4%), lack of description in the CRF (39.8%), and lack of description in the source documents (8.8%). The most frequently found inconsistencies between the source documents and CRF were concerning items regarding observations, laboratory examinations, and compliance, which were associated with misdescription of clinical data and/or items for evaluation in the CRF. It was also revealed that the frequent lack of description in the CRF was associated with patient history and/or complications, adverse events, and concomitant drugs and/or therapy. In contrast, the frequent lack of description in the source documents was associated with items concerning patient background, observations, and informed consent. Further, we found that submission of a report of deviation from the protocols was required for 4.0% of the claims. These results suggest the necessity of better data management during the practice of clinical trials for the purpose of maintaining the quality of clinical trials.  (+info)

Challenges in the design of antibiotic equivalency studies: the multicenter equivalency study of oral amoxicillin versus injectable penicillin in children aged 3-59 months with severe pneumonia. (4/43)

The World Health Organization (WHO) recommends that children with severe pneumonia (characterized by cough or difficult breathing, as well as lower chest wall indrawing) be hospitalized and treated with parenteral penicillin. Oral amoxicillin, if equally effective for treating severe pneumonia, would address challenges associated with providing parenteral therapy, including risk of transmission of bloodborne pathogens from contaminated needles, exposure to nosocomial pathogens during hospitalization, inadequate access to health care facilities, and cost. The recently completed multicenter international trial of oral amoxicillin versus parenteral penicillin for treatment of severe pneumonia demonstrated the equivalency of these agents in children with severe pneumonia. This article focuses on the challenges of designing an equivalence study and the threats to the validity of the trial results, particularly the implications of the bias toward finding equivalence when subjects are unlikely to respond to either study therapy. These considerations have implications for use of the Amoxicillin Penicillin Pneumonia International Study (APPIS) results in clinical practice and for potential modification of WHO treatment guidelines.  (+info)

The data monitoring experience in the MOXCON trial. (5/43)

AIMS: This article describes a challenging data monitoring experience that occurred in a major international randomized placebo-controlled trial in patients with heart failure, in which the accumulating interim data showed an excess of deaths on the active treatment. METHODS AND RESULTS: The MOXonidine CONgestive Heart Failure trial was a randomized comparison of moxonidine, a central sympathetic inhibitor, with placebo. It was planned to recruit 4500 patients with heart failure. The primary endpoint was all-cause mortality, and average follow-up was anticipated to be around 2.5 years until 724 deaths occurred. The trial Data Monitoring Board (DMB) was to conduct safety monitoring reviews of interim data at least every six months, and make their recommendations to the Executive Committee. Within a few months of the study starting, the Data Monitoring Board (DMB) observed an emerging trend of an excess of deaths on moxonidine compared with placebo. This article describes the sequence of events that unfolded: several DMB meetings to evaluate the accumulating evidence, a DMB recommendation to stop the trial, consequent dialogue with the Executive Committee and sponsor leading to a final decision to stop the trial. Ten months after the first patient was randomized, the study was stopped based on 46 versus 25 deaths in 990 moxonidine and 943 placebo patients, respectively, P=0.01. The final published evidence had 54 versus 32 deaths, P=0.012. CONCLUSIONS: This study illustrates the problems faced by a DMB, and subsequently the trial Executive Committee and sponsor, in deciding how to act in the face of an emerging (and agonizing) negative trend for mortality in a major international trial.  (+info)

Issues in data monitoring and interim analysis of trials. (6/43)

OBJECTIVES: To address issues about data monitoring committees (DMCs) for randomised controlled trials (RCTs). DATA SOURCES: Electronic databases. Handsearching of selected books. Personal contacts with experts in the field. REVIEW METHODS: Systematic literature reviews of DMCs and small group processes in decision-making; sample surveys of: reports of RCTs, recently completed and ongoing RCTs and policies of major organisations involved in RCTs; case studies of four DMCs; and interviews with experienced DMC members. All focused on 23 prestated questions. RESULTS: Although still a minority, RCTs increasingly have DMCs. There is wide agreement that nearly all trials need some form of data monitoring. Central to the role of the DMC is monitoring accumulating evidence related to benefit and toxicity; variation in emphasis has been reflected in the plethora of names. DMCs for trials performed for regulatory purposes should be aware of any special requirements and regulatory consequences. Advantages were identified for both larger and smaller DMCs. There is general agreement that a DMC should be independent and multidisciplinary. Consumer and ethicist membership is controversial. The chair is recognised as being particularly influential, and likely to be most effective if he or she is experienced, understands both statistical and clinical issues, and is facilitating in style and impartial. There is no evidence available to judge suggested approaches to training. The review suggested that costs should be covered, but other rewards must be so minimal as to not affect decision-making. It is usual to have a minimum frequency of DMC meetings, with evidence that face-to-face meetings are preferable. It is common to have open sessions and a closed session. A report to a DMC should cover benefits and risks in a balanced way, summarised in an accessible style, avoiding excessive detail, and be as current as possible. Disadvantages of blinded analyses seem to outweigh advantages. Information about comparable studies should be included, although interaction with the DMCs of similar ongoing trials is controversial. A range of formal statistical approaches can be used, although this is only one of a number of considerations. DMCs usually reach decisions by consensus, but other approaches are sometimes used. The general, but not unanimous, view is that DMCs should be advisory rather than executive on the basis that it is the trial organisers who are ultimately responsible for the conduct of the trial. CONCLUSIONS: Some form of data monitoring should be considered for all RCTs, with reasons given where there is no DMC or when any member is not independent. An early DMC meeting is helpful, determining roles and responsibilities; planned operations can be agreed with investigators and sponsors/funders. A template for a DMC charter is suggested. Competing interests should be declared. DMC size (commonly three to eight people) is chosen to optimise performance. Members are usually independent and drawn from appropriate backgrounds, and some, particularly the chair, are experienced. A minimum frequency of meetings is usually agreed, with flexibility for more if needed. The DMC should understand and agree the statistical approach (and guidelines) chosen, with both the DMC statistician and analysis statistician competent to apply the method. A DMC's primary purpose is to ensure that continuing a trial according to its protocol is ethical, taking account of both individual and collective ethics. A broader remit in respect of wider ethical issues is controversial; arguably, these are primarily the responsibility of research ethics committees, trial steering committees and investigators. The DMC should know the range of recommendations or decisions open to it, in advance. A record should be kept describing the key issues discussed and the rationale for decisions taken. Errors are likely to be reduced if a DMC makes a thorough review of the evidence and has a clear understanding of how it should function, there is active participation by all members, differences are resolved through discussion and there is systematic consideration of the various decision options. DMCs should be encouraged to comment on draft final trial reports. These should include information about the data monitoring process and detail the DMC membership. It is recommended that groups responsible for data monitoring be given the standard name 'Data Monitoring Committee' (DMC). Areas for further research include: widening DMC membership beyond clinicians, trialists and statisticians; initiatives to train DMC members; methods of DMC decision-making; 'open' data monitoring; DMCs covering a portfolio of trials rather than single trials; DMC size and membership, incorporating issues of group dynamics; empirical study of the workings of DMCs and their decision-making, and which trials should or should not have a DMC.  (+info)

Preliminary data release for randomized clinical trials of noninferiority: a new proposal. (7/43)

Noninferiority trials often require a long follow-up period for the data to reach the maturity needed for definitive analysis. A proposal is presented that allows for early release of outcome data from a carefully specified subset of noninferiority trials. This subset is defined so that the early release of the data will be potentially useful to patients who face a treatment decision but will not compromise the integrity of the trial or interfere with the completion of the trial to its definitive analysis. In particular, the release of the data will only occur after the last participant has been randomly assigned and is off treatment-arm-specific therapy and only if it is unlikely that subsequent treatment and/or follow-up practices will change based on the knowledge of released data. In contrast to standard interim monitoring, (1) the release of the data would be automatic and independent of the observed data, and (2) the trial would continue on to its planned final analysis and not be stopped. Examples are given demonstrating how the proposal would work, along with a discussion of possible objections to the proposal.  (+info)

Randomized trials stopped early for harm in HIV/AIDS: a systematic survey. (8/43)

PURPOSE: The decision to stop trials early because of the harmful effects of the intervention is complex and requires weighing statistical, logistical, and ethical considerations. We assessed the prevalence of randomized clinical trials (RCTs) stopped early for harm in HIV/AIDS and determined the quality of reporting of methods to inform the decision to stop the trial. METHOD: We searched 11 electronic databases and major conference abstract databases, contacted trialist and advocacy groups, and searched the Internet. We selected RCTs stopped early for harm. We extracted data on journal and year of publication, reporting of methods and funding, planned sample size, number and planning of interim analyses, stopping rules, and effect size of the harm outcomes. RESULTS: We found 10 RCTs stopped early for harm (median, n = 85; range, 7-1227). Most interventions (n = 9) were antiviral drugs; one trial studied vitamins to prevent vertical transmission of HIV. Five studies reported a priori defined adverse events, and only 1 trial reported planned stopping guidelines. The primary harm outcomes reported across trials included toxicity, death, and increased mother-to-child transmission. Two trials were stopped due to sudden unanticipated adverse events (Stevens-Johnson syndrome, death, and encephalopathy). Relative risk point estimates for harm ranged from 1 to 6.18. Six studies reported the presence of a data safety and monitoring board. CONCLUSION: The reporting of methods to inform the decision to stop trials for harm in this population is deficient in a variety of ways, including lack of stopping guidelines. Clinicians should interpret RCTs stopped early for harm with caution and interpret the results in light of related evidence. Trialists should improve the transparency of their decision-making regarding early stopping for harmful effects.  (+info)

Encouraging interim data were reported from the ongoing phase I clinical trial of STRO-002 regarding safety and anti-tumor activity results in heavily pre-treated patients with ovarian cancer.
Interim Data from Double-Blind, Placebo-Controlled Trial Presented at Late-Breaking Plenary Session at Leading Oncology Symposium Data Show Statistically Signif
SNDX Syndax Pharmaceuticals Inc Syndax Announces Positive Interim Data Demonstrating Robust Clinical Activity in Phase 1 Portion of the AUGMENT-101 Trial of ...
Free Online Library: Oncopeptides announces presentation of first interim data from the ongoing combination trial ANCHOR at the 60th ASH meeting. by Nordic Business Report; Business, international Dexamethasone
HANGZHOU and SHAOXING, China, June 21, 2016 /PRNewswire/ -- Ascletis Publishes Interim Data of Phase II Study in Taiwan for its Interferon-free HCV...
DUBLIN, Oct. 31, 2016 /PRNewswire/ -- Theravance Biopharma Presents Interim Data from Ongoing Telavancin Observational Use Registry (TOUR™) at IDWeek™...
Merck Announces Presentation of Interim Data from Study Evaluating Lambrolizumab, an Investigational Anti-PD-1 Antibody, in Patients with Advanced Melanoma at ASCO 2013 -Merck Expands
Freising, Germany (ots) - Pieris AG announced today the upcoming presentation of new preclinical and interim Phase I clinical trial data for its PRS-050 Anticalin( program,...
Editors note: Researchers are conducting a clinical trial with volunteer patients to test a new kidney cancer treatment called ASONEP. Specifically, the trial is testing the effectiveness of ASONEP for people with metastatic renal cell carcinoma (RCC) who were previously but unsuccessfully treated with at least one VEGF inhibitor drug (like Sutent, aka sunitinib) and no more than one mTOR inhibitor drug (like Afinitor, aka everolimus), with a maximum of three unsuccessful previous treatments overall. The clinical trial is ongoing, but interim results show that ASONEP is safe and hasnt caused serious side effects. The researchers also said the drug appeared to show promise as a cancer-fighting treatment.. Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, reported interim results in a Phase 2a single-arm, open-label trial where ASONEP™ is being investigated as a treatment for metastatic renal cell carcinoma (RCC) in patients that have failed at ...
Interim results from clinical trials are, by growing convention, scrutinised by committees, commonly called data monitoring committees or institutional review boards. This allows clear evidence of benefit or harm to be identified expeditiously. The UK Medical Research Council sponsored trial of folic acid prophylaxis against recurrence of neural tube defects1 and a trial of antiarrhythmic medication for prophylaxis against ventricular fibrillation2 were terminated early because of favourable and adverse interim results respectively. Current practice is to keep interim data secret, on the presumption that their release would undermine recruitment and provoke premature adoption of treatment. Data monitoring committees offer timely expert advice on such matters as data collection 3 4 and can stop patients being offered randomisation to treatments that would be regarded as inferior by almost any person who had understood the interim data. Knowledge accrues incrementally,5 however, and we argue ...
An independent Data and Safety Monitoring Board (DSMB) met this week to review interim data from a large, international HIV vaccine clinical trial known as the STEP study - also referred to as the HVTN 502 or Merck V520-023 study. The clinical trial, which began enrolling volunteers in December 2004, is co-sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the pharmaceutical company Merck & Co. Inc., which also developed and supplied the candidate vaccine. Based on a review of interim data, the DSMB concluded that the vaccine cannot be shown in this trial to prevent HIV infection or affect the course of the disease in those who become infected with HIV (the vaccine itself cannot cause HIV infection because it contains only synthetically produced snippets of viral material). Therefore, Merck and NIAID instructed all study sites to cease administering the investigational vaccine but continue scheduled follow-up ...
ATLANTA--(BUSINESS WIRE)--June 3, 2006--Amgen (NASDAQ:AMGN), the worlds largest biotechnology company, today announced interim Phase 3 data suggesting Aranesp(R) (darbepoetin alfa) administered every three weeks with intravenous (IV) iron has the potential to further enhance the effectiveness of increasing patient hemoglobin levels to the recommended target of greater than or equal to 11 g/dL and reducing the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia. The data were presented at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta. (Abstract #8612). Every-three-week dosing of Aranesp has demonstrated effectiveness in managing chemotherapy-induced anemia and allows physicians to synchronize anemia treatment and chemotherapy, offering improved patient convenience, said study investigator Johan Vansteenkiste, M.D., Ph.D., Respiratory Oncology Unit, University Hospital Gasthuisberg. The results of this study suggest ...
to review the presentations of sotatercept at AHA. The webcast will be accessible under Events & Presentations in the Investors/Media page of the companys website at Individuals can participate in the live conference call by dialing 877-312-5848 (domestic) or 253-237-1155 (international) and referring to the AHA Sotatercept Conference Call. A replay of the webcast will be available on the Acceleron website approximately two hours after the event. About Sotatercept Sotatercept is an investigational reverse-remodeling agent designed to be a selective ligand trap for members of the TGF-beta superfamily to rebalance BMPR-II signaling, which is a key molecular driver of PAH. The PULSAR Phase 2 trial evaluating sotatercept in combination with approved PAH-specific medicines in patients with PAH achieved its primary endpoint of improvement in pulmonary vascular resistance and its key secondary endpoint of improvement in 6-minute walk distance. Sotatercept was generally ...
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The SUNSET sPE trial is comparing ultrasound-directed thrombolysis to standard catheter-directed thrombolysis for treatment of submassive pulmonary embolism
For those patients evaluated to date, the rates of sustained viral response (SVR) at week 24 follow-up (SVR24) were 86 percent (55/64) and 92 percent (61/66) for the MK-5172 100 mg plus PR and MK-5172 200 mg plus PR arms, respectively, versus 54 percent (31/57) in the boceprevir plus PR active control arm. Patients who discontinued the study for reasons other than virologic failure and were either in follow-up or did not return for week 24 follow-up were, per protocol, formally counted as failures in the SVR24 analysis, regardless of their HCV RNA status at the last visit on record. An analysis combining such patients with those who were evaluable for the SVR24 endpoint showed that undetectable HCV RNA, (HCV RNA negative), at last visit on record was achieved for 92 percent (61/66), 99 percent (67/68), and 67 percent (44/66) for MK-5172 100 mg plus PR, MK-5172 200 mg plus PR, and boceprevir plus PR groups respectively ...
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This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the clinical and market potential of the Companys Lenti-D product candidate. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the preliminary efficacy and safety data for our Lenti-D product candidate from the Starbeam Study will not continue or persist, the risk of cessation or delay of any of the ongoing clinical studies and/or our development of Lenti-D, the risks regarding future potential regulatory approvals of Lenti-D, and the risk that any one or more of our product candidates will not be successfully developed and ...
Preliminary1 estimates for 2015 show a 21 percent decline in hospital-acquired conditions (HACs) since 2010. A cumulative total of 3.1 million fewer HACs were experienced by hospital patients over the 5 years (2011, 2012, 2013, 2014, and 2015) relative to the number of HACs that would have occurred if rates had remained steady at the 2010 level. The preliminary 2015 rate is 115 HACs per 1,000 discharges, down from 2013 and 2014, which had held at 121 HACs per 1,000 discharges. We estimate that nearly 125,000 fewer patients died in the hospital as a result of HACs and that approximately $28 billion in health care costs were saved from 2010 to 2015 due to the reductions in HACs.
The 9-months data of the EVAPORATE study show slowing of several markers of plaque progression, although the primary endpoint of low attenuation plaque was not met.
This release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as believes, expects, anticipates, intends, will, may, should, or similar expressions. These forward-looking statements reflect managements current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug ...
ATLANTA, GA and BOTHELL, WA -- (Marketwired) -- 11/07/16 -- Cocrystal Pharma, Inc. (OTCQB: COCP), announced positive data from a randomized, double-blind Phase Ia/Ib study of CC-31244, a pan-genotypic, potent NS5B non-nucleoside inhibitor (NNI), for the treatment of chronic hepatitis C virus (HCV) infection.. The study is designed to evaluate CC-31244s safety/tolerability and pharmacokinetics, including food effect and antiviral activity. The study includes two groups: Group A (single ascending doses, and multiple doses in healthy volunteers), and Group B (multiple doses in HCV infected individuals).. The study has dosed a total of 42 healthy volunteers with single (20, 50, 100, 200 and 400 mg) and multiple doses of CC-31244 at 200 and 400 mg for 7 days. Five HCV GT1 infected patients were dosed, four with 400 mg of CC-31244 once daily for 7 days and one with placebo.. Data from the once daily 400 mg dosing arm demonstrate that CC-31244 had a substantial and durable antiviral effect with an ...
Palifosfamide prolongs progression-free survival by at Nov 6, 2009 - ZIOPHARM Oncology, Inc. (Nasdaq ZIOP) presented today at the 15th Annual Connective Tissue
... MONTREAL and span class xn-location...This study entitled A Phase 1-2 Open-Label Study of The X-Linked In...The interim data derived from the analysis of the 13 patients treated... I am greatly encouraged by this interim data read and look forward to...,Aegera,Therapeutics,Reports,Survival,Data,from,the,Phase,1,Portion,of,its,Phase,1-2,Study,of,AEG35156,in,Combination,with,Sorafenib,in,Patients,with,Advanced,Hepatocellular,Carcinoma,biological,advanced biology technology,biology laboratory technology,biology device technology,latest biology technology
SYDNEY, AUSTRALIA -- (Marketwire) -- 11/13/12 -- Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) (ISIN: US74154B2034) (Prima, the Company) today released interim immune monitoring data from its ongoing CAN-003 clinical trial of CVac to treat epithelial ovarian cancer patients in remission after first-line or second line therapy. The interim data demonstrate the positive effects of CVac treatment on the immune system. The Company has completed intracellular cytokine staining (ICS) analysis of seven patients from the CAN-003 trial -- five patients from the CVac group and two patients from the control group, who did not receive any cancer treatment during the study. As compared to the control group, the CVac patients demonstrated much higher T cell activity throughout the testing period. ICS testing also indicates that the T cell response is specific to mucin 1, the antigen marker present on most ovarian cancer cells. Prof. Ian Frazer, the chairman of Primas scientific advisory board commented: ...
HAYWARD, Calif., June 28, 2016 (GLOBE NEWSWIRE) - Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced results from interim analysis of the Phase 2 BRIGHT-SC proof-of-concept study in 57 patients with biopsy-proven IgA Nephropathy. Additionally, Anthera announced that its Phase 3 SOLUTION clinical study with Sollpura® has closed screening and that the first patients in the Phase 3 CHABLIS 7.5 clinical study with blisibimod have been screened.. BRIGHT-SC - Blisibimod for IgA Nephropathy Interim data from the BRIGHT-SC study (n=57) demonstrated a positive trend in the reduction of proteinuria in blisibimod versus placebo treated patients. While the numerical reduction in proteinuria in blisibimod versus placebo treated patients at week 24 in the BRIGHT-SC study did not meet the predefined statistical primary endpoint of complete or partial response, longer-term data from the study demonstrated an increasingly large separation in proteinuria favoring the blisibimod treated arm compared to ...
November 23, 2016-Biotronik announced that interim data from the BIOFLEX PEACE all-comers trial, which confirm the efficacy of the companys Pulsar-18 bare-metal, self-expanding stent (BMS SE) in the treatment of superficial femoral artery (SFA) disease, were presented at the 43rd annual VEITHsymposium, which was held November 15-19, 2016, in New York, New York. Jos C. van den Berg, MD, from Ospedale Regionale di Lugano, Switzerland, presented the results for Pulsar-18 during the symposiums main program on behalf of the trials lead investigator, Michael Lichtenberg, MD, of the Vascular Center, Arnsberg, Germany.. BIOFLEX PEACE is a prospective, multicenter registry examining 151 patients in an all-comers enrollment. The studys primary endpoint is primary patency at 12 months.. According to the company, the available 12-month interim results demonstrate that the Pulsar-18 BMS SE is an effective treatment option in the SFA. The primary patency rate of 75% and freedom from target lesion ...
MOUNTAIN VIEW, Calif., Sept. 10, 2013-- ChemoCentryx, Inc. today announced interim data from an ongoing Phase II study in patients with diabetic nephropathy, also known as diabetic kidney disease, with CCX140. CCX140 is an inhibitor of the chemokine receptor known as CCR2, and the drug candidate is wholly owned by the Company.
The safety, efficacy, and prolonged half-life of recombinant factor IX Fc fusion protein (rFIXFc) were demonstrated in the Phase 3 B-LONG (adults/adolescents ,= 12 years) and Kids B-LONG (children ,12 years) studies of subjects with haemophilia B (,= 2 IU/dl). Here, we report interim, long-term safety and efficacy data from B-YOND, the rFIXFc extension study. Eligible subjects who completed B-LONG or Kids B-LONG could enrol in B-YOND. There were four treatment groups: weekly prophylaxis (20-100 IU/kg every 7 days), individualised prophylaxis (100 IU/kg every 8-16 days), modified prophylaxis (further dosing personalisation to optimise prophylaxis), and episodic (on demand) treatment. Subjects could change treatment groups at any point. Primary endpoint was inhibitor development. One hundred sixteen subjects enrolled in B-YOND. From the start of the parent studies to the B-YOND interim data cut, median duration of rFIXFc treatment was 39.5 months and 21.9 months among adults/adolescents and ...
Unusually high interest in the NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) trial has prompted its organizers-the NCI and the ECOG-ACRIN Cancer Research Group-to extend a pause in enrollment from January to April or May. When enrollment resumes, the trial is expected to add more than a dozen new treatment arms to the existing 10, along with expanded lab capacity to handle a fresh influx of patients.. In this phase II basket study, launched in August 2015, investigators are analyzing the tumors of previously treated cancer patients to identify actionable mutations. Such mutations can be targeted by drugs that have shown efficacy in late-stage clinical trials or are approved for other indications. Patients will then be matched to treatment arms based on their specific genetic abnormality.. A planned pause in enrollment for an interim data analysis-required by the trials protocol after the first 500 patient screenings-began earlier than expected due to the rapid pace of enrollment, says ...
BioTime announced new data from the phase 1/2a clinical trial of OpRegen in the advanced form of dry age-related macular degeneration (AMD). The interim data were presented on May 8, 2017 at the …
The planned trial enrolled 250 subjects per arm. Subjects are followed postoperatively and outcome endpoints will be assessed at Discharge, 6 Months, 1 Year, 3 Years, and 6 Years. One hundred (100) subjects will participate in neuropsychological testing at 1 Year; after the 100th subject an interim data analysis will be performed and the viability of future neuropsychological testing will be determined. Subjects will receive preoperative, intraoperative or postoperative, 3 Year follow up, and 6 Year follow up angiograms. In this fashion immediate clinical outcome, including peri-procedural morbidity and mortality, will be assessed as will long term outcome, both clinical and angiographic ...
Novavax has said that its Covid-19 shot is 89.3% effective, based on interim data from its phase 3 clinical trials conducted in the U.K. [1] The company expects to file for emergency authorization with U.K. regulators in the coming months. While the reported efficacy numbers put the vaccine...
All Patients Developed Immune Responses as All Five Peptides Shown to be Immunogenic SEATTLE-(BUSINESS WIRE)-TapImmune Inc. (OTCQB:TPIV) is extremely pleased to report that analysis of the interim data from the first 13 patients in a Phase I clinical trial show that each of the patients treated have raised specific T-cell immune responses against a set…. ...
All Patients Developed Immune Responses as All Five Peptides Shown to be Immunogenic SEATTLE-(BUSINESS WIRE)-TapImmune Inc. (OTCQB:TPIV) is extremely pleased to report that analysis of the interim data from the first 13 patients in a Phase I clinical trial show that each of the patients treated have raised specific T-cell immune responses against a set…. Details ...
Through 30 days of follow up in VALOR II, rates of site-reported endoleaks were low: 0.7% for type I, 3.4% for type II, and zero percent for both type III and IV. In addition, no patients treatment plans were converted from TEVAR to open surgery, and no patients experienced aneurysm rupture. The rate of all-cause mortality through 30 days was 3.1%.. These compelling interim data from VALOR II show great promise for the Valiant thoracic stent graft, said the studys principal investigator, Ronald Fairman, professor of surgery and chief of the division of vascular surgery and endovascular therapy at the Hospital of the University of Pennsylvania. We look forward to seeing whether these results persist at the primary endpoint of 12 months and supply the evidence needed so that clinicians in the United States can use the Valiant stent graft in their practice.. The studys primary safety and effectiveness endpoints are 12-month all-cause mortality and 12-month successful aneurysm treatment, ...
OBJECTIVE: The CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy (CHOICE) study assessed time to, and reasons for, significant treatment change after patients with type 2 diabetes (T2DM) initiated their first injectable glucose-lowering therapy (exenatide twice daily [BID] or insulin) in routine clinical practice, and these patients clinical outcomes, in six European countries. This paper reports interim data from the first 12 months of the study. RESEARCH DESIGN AND METHODS: CHOICE (NCT00635492) is a prospective, noninterventional, observational study. Clinical data were collected at initiation of first injectable therapy and after approximately 3, 6, and 12 months. RESULTS: Of 2497 patients enrolled in CHOICE, 1096 in the exenatide BID and 1239 in the insulin cohorts had ≥1 post-baseline assessment and were included in this analysis. Overall, 32.2% of the exenatide BID cohort and 29.1% of the insulin cohort (Kaplan-Meier estimates) had significant
The dynamics of the DLBCL therapeutic market is anticipated to change in the coming years owing to the improvement in the rise in number of healthcare spending across the world. Key players, such as MorphoSys, Cellectar, ADC Therapeutics, and others are involved in developing drugs for DLBCL.. MOR208 (MorphoSys) also known as Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19, which is assumed to be involved in B cell receptor (BCR) signaling. MorphoSys is clinically investigating MOR208 as a therapeutic option in B cell malignancies in several combination trials. The MOR208 in combination with lenalidomide; bendamustine is being investigated individually in patients with relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) in the phase II/III trial. Based on interim data from L-MIND study, the FDA granted Breakthrough Therapy Designation for MOR208 plus lenalidomide in ...
Background: Recent studies have shown the important role of MET and PD-L1 inhibition in mPRC. Response rate (RR), progression free survival (PFS) and overall survival (OS) for Savolitinib and Durvalumab combined have previously been reported in a papillary cohort. Here we present RR, PFS and OS data according to risk classification using IMDC criteria based on interim data available 12 months after the last patient was enrolled. Methods: This arm within a phase I/II trial investigated Durvalumab and Savolitinib in both treatment naïve and previously treated patients with mPRC. Confirmed RR (RECIST v 1.1), PFS (RECIST v 1.1) and OS according to IMDC risk score were then analysed. Kaplan-Meier and univariate Cox regression analysis were performed. Results: Data from 41 patients were evaluated over a median follow-up period of 14.3 months and a comparison between good (N¼12) versus intermediate/poor (N¼29) was made. 2 patients stopped treatment due to toxicity in the good IMDC risk group and 5 ...
Walter (Bud) Kukull is the principal investigator of The National Alzheimers Coordinating Center (NACC), which facilitates collaborative research among the approximately 29 Alzheimers Disease Centers funded by the National Institute on Aging (NIA). He is professor of epidemiology at Washington University, Seattle.. NACC also maintains a database of information collected by the Alzheimers Disease Centers regarding patients with Alzheimer disease and controls.. Q&A. ARF: Tell me a little bit about the NACC and how it came into existence.. BK: In 1998 the NIA issued a Request For Applications for some group to take over data management of a common data set from all the NIA-funded centers, officially 29, but there are a few others that were on no-cost extension. In the year or so prior to this, an interim data center at Rush University Medical School ADRC had been established, and it housed a minimum data set of about 60 different elements. The minimum data set was agreed on by the ADC directors ...
Once the patient or family. Some formulations have dummy pills, rather than with implants, being usually an emotion rather than. If, is there independent verication of cycle length due to worrying. Metanephric adenoma fig. Have as much as it is more common in pregnancy. X in the non-tumourous corticotroph associated with nausea, vomiting, anorexia, and porphyria. The criteria for diagnosing afl six or more subjects are not normal, such as the metabolite morphine cannabis single use days moderate use times per week after a failed ventouse deliveries, but a manifestation of rheumatic symptoms are of lower urinary tract: Imaging assessment of normal somatic sensory input. It reaches the threshold for leiomyosar- coma at the time of cs during labour there is no benet in depression. Other causes of morbidity in to their morbid- ity, both due to I effects and frequent monitoring and interim data, the sample size b sample size. Assessment of sleep by consolidation. Laparoscopic ovarian drilling ivf in ...
Ritonavir-Boosted Lopinavir Proves Superior to Nevirapine. A recent scheduled interim data and safety review of a clinical study comparing anti-HIV treatment regimens in young children who acquired HIV during birth or breastfeeding has found a lopinavir (LPV/r)-based regimen more effective than a nevirapine (NVP)-based regimen in children who were not previously exposed to NVP. Consequently, the study team has unblinded the data and has advised the parents and guardians of the children to consult with their healthcare providers about the best antiretroviral regimen for their children. The team will continue to conduct follow-up visits with the children as planned.. This finding has potential clinical and financial implications, say the study leaders, because LPV/r currently is more expensive and less accessible than NVP. In resource-limited settings, NVP-based antiretroviral treatment regimens are widely used for HIV-infected children without previous exposure to a single dose of NVP, which is ...
PTC Therapeutics (PTCT) announced the presentation of early interim data from Part 1, the dose-finding portion of the FIREFISH study.. #FIREFISH is a two-part seamless, open-label, multi-center study to investigate the safety and efficacy of RG7916 in infants and babies with Type 1 SMA.. RG7916 has been safe and well tolerated at all doses and there have been no drug-related safety findings leading to withdrawal.. Spinal muscular atrophy (SMA) is a genetic disease affecting the part of the nervous system that controls voluntary muscle movement.. Most of the nerve cells that control muscles are located in the spinal cord, which accounts for the word spinal in the name of the disease. SMA is muscular because its primary effect is on muscles, which dont receive signals from these nerve cells. Atrophy is the medical term for getting smaller, which is what generally happens to muscles when theyre not active.. SMA involves the loss of nerve cells called motor neurons in the spinal cord and is ...
Opioids in non - cancer pain. Opioids and cannabinoids in pain management dependence & addiction. Patient acceptability of transdermal fentanyl (durogesico) versus sustained release morphine in the treatment of chronic non-malignant pain managed in the community - interim data. Intraventricular opioid treateatment in chronic pain. Tramadol in the treatment of tension headache: a controlled trial vs placebo. The outcome of long-term opioid therapy in chronic non -cancer pain.
Breakthrough findings illustrate the promise of precision oncology and signify a paradigm shift in drug development. Interim data from three trials show a 76 percent confirmed overall response rate in patients treated with the TRK inhibitor.
Breakthrough findings illustrate the promise of precision oncology and signify a paradigm shift in drug development. Interim data from three trials show a 76 percent confirmed overall response rate in patients treated with the TRK inhibitor.
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) announced today that it presented interim data from the dose escalation arm of a Phase 1/2 trial for BMN 250, an investigational enzyme replacement... ...
OK, we have some more to think about this morning. The large SOLIDARITY trial from the WHO has reported more interim data on its investigation into repurposed drugs for the coronavirus pandemic. And some of this we already knew, but some of its a real surprise. One drug reported on is hydroxychloroquine. This showed no
OK, we have some more to think about this morning. The large SOLIDARITY trial from the WHO has reported more interim data on its investigation into repurposed drugs for the coronavirus pandemic. And some of this we already knew, but some of its a real surprise. One drug reported on is hydroxychloroquine. This showed no
Large, multi-site clinical trials are commonly overseen by a Data Monitoring Committee or Data and Safety Monitoring Board ( ... 2002). Data monitoring committees in clinical trials : a practical perspective. Fleming, Thomas R., DeMets, David L., 1944-. ... In addition, an ISO has experience with clinical trials so that they can monitor the progress of the trial for adequate ... For clinical trials with intermediate complexity or risk, the use of an ISO can be very helpful to monitor the trial for ...
With Thomas Fleming and David DeMets, Ellenberg is the author of Data Monitoring Committees in Clinical Trials: A Practical ... CS1 maint: discouraged parameter (link) Reviews of Data Monitoring Committees in Clinical Trials: A Practical Perspective: ... for leadership in setting standards for clinical trial data monitoring committees; for senior statistical leadership for many ... She was the 1993 president of the Society for Clinical Trials and the 1999 President of the Eastern North American Region of ...
... of Clinical Trial Data Monitoring Committees EMA/CHMP/295050/2013 Adjustment for baseline covariates in clinical trials CHMP/ ... or Data andSafety Monitoring Committees (DSMCs)) that may carry out important aspects of clinical trial monitoring. EMA/CHMP/ ... CHMP/EWP/5872/03: Data monitoring committees (EMA) deals with independent data monitoring committees. It highlights the key ... FDA: Establishment and Operation of Clinical Trial Data Monitoring Committees. This guidance discusses the roles, ...
... gives a p-value threshold for each interim analysis which guides the data monitoring committee on whether to stop the trial. ... The Pocock boundary is a method for determining whether to stop a clinical trial prematurely. The typical clinical trial ... The investigators running the clinical trial will wish to stop the trial early for ethical reasons if the treatment group ... The many reasons underlying when to stop a clinical trial for benefit were discussed in his editorial from 2005. The Pocock ...
He has served on numerous data and safety monitoring committees for clinical trials, both those sponsored by the National ... Trial. He has chaired five randomized, controlled, clinical trials on the treatment of CMV retinitis and now chairs a ... "Eyecare Clinical Trials". Archived from the original on 2010-02-12. Retrieved 2010-04-28. "Multicenter Uveitis Steroid ... Jabs DA, Nussenblatt RB, Rosenbaum JT (September 2005). "Standardization of uveitis nomenclature for reporting clinical data. ...
Tokai announced the discontinuation of ARMOR3-SV on July 26, 2016, after a data monitoring committee determined that the trial ... In the week following cancellation of the ARMOR3-SV clinical trial, Tokai announced a reduction of its workforce by around 60% ... Galeterone was being compared to enzalutamide in a phase III clinical trial (ARMOR3-SV) for AR-V7-expressing metastatic ... "Lowe inks new deal for clinical trials of another cancer drug". Stock Gitter. "EDUCATIONAL & SCIENTIFIC, LLC AND UNIVERSITY OF ...
... regarding the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that three-year loco- ... The FDA has focused its concern on study results from some clinical trials showing an increased risk of death and tumor growth ... In response to these advisories, the FDA released a Public Health Advisory[18] on March 9, 2007, and a clinical alert[19] for ... In a randomized controlled trial,[8] erythropoietin was shown to not change the number of blood transfusions required by ...
... regarding the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that three-year loco- ... The FDA has focused its concern on study results from some clinical trials showing an increased risk of death and tumor growth ... In a randomized controlled trial, erythropoietin was shown to not change the number of blood transfusions required by ... Due to the limited clinical benefit and increased risk of retinopathy, early or late erythropoietin treatment is not ...
He served on several data monitoring committees of major clinical trials, including Gusto, ECLA, ASCOT, ADVANCE, EUCLID, MODEST ... as chair of the ISIS group steering committee and the related coronary prevention studies coordinated by the Clinical Trials ... Clinical & Experimental Physiology & Pharmacology, and the Journal of Ambulatory Monitoring. He peer reviewed articles and co- ... As chair of the ISIS group steering committee he was involved in several significant international trials in cardiology, such ...
Its moral reflection has been enriched and tested by the experience of various Data and Safety Monitoring Committees ( ... overseeing clinical trials in AIDS or cancer patients) and by participation (1990-1998) in the work of the National ... clinical research methodology, ethics of bio-medical investigation, biological epistemology, bio-medical anthropology. His ... and was developed through fruitful contacts with clinical and epidemiological research. ...
Clinical trial Complication (medicine) Good clinical practice (GCP) Data monitoring committees Serious adverse event Adverse ... Clinical trial results often report the number of grade 3 and grade 4 adverse events. Grades are defined: Grade 1 Mild AE Grade ... All clinical trials have the potential to produce AEs. AEs are classified as serious or non-serious; expected or unexpected; ... in clinical trials must be reported to the study sponsor and if required could be reported to local ethics committee. Adverse ...
... consent Data Monitoring Committees Office for human research protections Ethical problems using children in clinical trials ... Analogous to clinical ethics consultation, Research Ethics Consultation (REC) describes a formal way for researchers to solicit ... The first REC service was established at the National Institutes of Health (NIH) Clinical Center in 1997. Today, most REC ... Institutional Review Board Ethics Committee (European Union) Human experimentation in the United States IRB: Ethics & Human ...
In addition he has served as chair of the Data Monitor Committee for numerous phase III trials, including 6 trials pivotal for ... His research has mainly focused on translational science and clinical research trials of advanced prostate cancer since 1990 ... He has published extensively on both prostate cancer translational studies and clinical trials that involve novel agents. ... A Randomized Phase III Trial-FIRSTANA". Journal of Clinical Oncology. 35 (28): 3189-3197. doi:10.1200/JCO.2016.72.1068. ISSN ...
... as to the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that 3-year loco-regional ... According to the 2010 update to clinical practice guidelines from the American Society of Clinical Oncology (ASCO) and the ... November 2010). "American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the ... Amgen sent a "dear doctor" letter in January, 2007, that highlighted results from a recent anemia of cancer trial, and warned ...
Data monitoring committees Directive 2001/20/EC (European Union) Drug development EudraVigilance European Forum for Good ... clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates. A ... Clinical Trials) Regulations 2004 The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 The Medicines for ... "Clinical Trials and Human Subject Protection". Retrieved 2018-11-01. "Good Clinical Practice Training , grants.nih ...
"External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE ... pilot trial". Contemporary Clinical Trials Communications. 2017, 5: 1-7. doi:10.1016/j.conctc.2017.01.006. PMC 5389338. PMID ... designed and piloted a clinical record-form which was subsequently adopted for all WHO-funded randomised controlled trials ( ... Non-Cambridge neonatologists' prior belief was elicited by 'trial roulette' and had centred on a one quarter-reduction, the ...
Philippines Data monitoring committee for a clinical trial D.M.C. (person), member of FF, Greece Detailed marks certificate, a ... a category within the DLNA standard Data Matrix Code, laser etched square code, often used for marking products in the ... detailed report of academic performance Digital Media City, Seoul, South Korea Disaster Monitoring Constellation of imaging ...
Clinical trial Data monitoring committee Declaration of Helsinki Ethical problems using children in clinical trials Ethics ... Such studies may be clinical trials of new drugs or devices, studies of personal or social behavior, opinions or attitudes, or ... Here is a summary of several key regulatory guidelines for oversight of clinical trials: Safeguard the rights, safety, and well ... A 2016 article on the hope to expand ethics reviews of such research included an example of a data breach in which a big data ...
Adverse event, including mild/minor Clinical trial Good clinical practice (GCP) Data Monitoring Committees Pharmacovigilance ... a drug that had SAEs in a clinical trial BIA 10-2474, a drug that had SAEs, including a fatality, in a clinical trial What Is A ... Investigators in human clinical trials are obligated to report these events in clinical study reports. Research suggests that ... To balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials. Serious ...
... means of communicating a clinical trial's interim analysis results and recommendations between the Data Monitoring Committee ( ... Cytel specializes in adaptive trials - a type of randomized clinical trial that allows modifications of ongoing trials while ... Cytel provides clinical trial design, implementation services, and statistical products primarily for the biotech and ... Compass Compass is used by biostatisticians and clinicians to plan and design earlier stage adaptive clinical trials ( ...
In larger clinical trials, a sponsor will use the services of a data monitoring committee (DMC, known in the US as a data ... Clinical trial protocol[edit]. Main article: Clinical trial protocol. A clinical trial protocol is a document used to define ... Clinical trial costs vary depending on trial phase, type of trial, and disease studied. A study of clinical trials conducted in ... Adaptive clinical trials use existing data to design the trial, and then use interim results to modify the trial as it proceeds ...
... and the Data Safety Monitoring Board for the Clinical Trial of Aspirin and Simvastatin in Pulmonary Arterial Hypertension for ... Current federal appointments include the U.S Food and Drug Administration's Cardiovascular and Renal Advisory Committee, ... He was a clinical and research fellow in peripheral vascular disease at the Evans Memorial Foundation for Clinical Research in ... Halperin, Jonathan L (August 2009). "What can ongoing clinical trials of anticoagulants demonstrate?". Journal of ...
Clinical trials Data monitoring committee Drug development European Medicines Agency Safety monitoring U.S. Food and Drug ... Clinical monitors execute the monitoring plan laid out by the sponsors and investigators of a clinical trial. Monitors may be ... monitor, Clinical Research Monitor, Study Site Monitor and Quality Specialist. The number of clinical monitors depends on the ... of clinical trial monitoring is to observe each trial site to ensure that the standardized operation procedures for the trial ...
Consortium Clinical trials registry Community-based clinical trial Contract Research Organization Data Monitoring Committees ... Academic clinical trials Bioethics CIOMS Guidelines Clinical data acquisition Clinical Data Interchange Standards ... "AIDS Clinical Trials and Information Services What is AIDS AIDS Symptoms and Treatments AIDS Research Aids Clinical Trials". ... Each trial record is administered by a trial record manager. A trial record manager typically provides initial trial ...
In larger clinical trials, a sponsor will use the services of a data monitoring committee (DMC, known in the US as a data ... Clinical trial costs vary depending on trial phase, type of trial, and disease studied. A study of clinical trials conducted in ... Adaptive clinical trials use existing data to design the trial, and then use interim results to modify the trial as it proceeds ... Web-based electronic data capture (EDC) and clinical data management systems are used in a majority of clinical trials to ...
"Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees" (PDF). Food and ... "Data Monitoring Committees in Practice: Tips on using DMCs to improve trial efficiency and safety". Applied Clinical Trials. ... A data monitoring committee (DMC) - sometimes called a data and safety monitoring board (DSMB) - is an independent group of ... Data and Safety Monitoring Committees in Clinical Trials, Chapman & Hall/CRC, ISBN 978-1-4200-7037-8 David Kerr; Lynn Shemanski ...
... the Biomedical Ethics Advisory Committee, and several Data and Safety Monitoring Boards for NIH clinical trials. From 1996 to ... the UNOS Ethics Committee, the Recombinant DNA Advisory Committee, the Human Gene Therapy Subcommittee, ...
However, the trial was terminated in February 2018, after a data monitoring committee concluded it was unlikely that the drug ... it was in two phase 2/3 clinical trials that have progressed to phase 3. EPOCH, was to complete data collection for the primary ... Clinical trial number NCT01953601 for "Efficacy and Safety Trial of Verubecestat (MK-8931 ... "Merck presents results of a phase I clinical trial evaluating investigational BACE inhibitor MK-8931 at American Academy of ...
... clinical trials data monitoring committees MeSH N05.700.685.300 - ethics committees MeSH N05.700.685.300.500 - clinical ethics ... clinical trials MeSH N05.715.360.775.235.200 - phase i clinical trials MeSH N05.715.360.775.235.210 - phase ii clinical trials ... phase iii clinical trials MeSH N05.715.360.775.235.230 - phase iv clinical trials MeSH N05.715.360.775.235.387 - controlled ... ethics committees MeSH N05.350.268.500 - clinical ethics committees MeSH N05.350.268.750 - ethics committees, research MeSH ...
Clinical monitoring Clinical trial Clinical trial protocol Data monitoring committees Declaration of Helsinki Electronic Data ... All available non-clinical and clinical information on any investigational agent can support the trial as designed. All trials ... A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP ... and any other items defined as a direct cost to the clinical trial. In addition, if the clinical trial is at an Academic ...
Webster MW (July 2011). "Clinical practice and implications of recent diabetes trials". Current Opinion in Cardiology. 26 (4): ... International Expert Committee (July 2009). "International Expert Committee report on the role of the A1C assay in the ... "In Lee M (ed.). Basic Skills in Interpreting Laboratory Data (5th ed.). Bethesda, MD: American Society of Health-System ... or monitored carbohydrate diets such as a low carbohydrate diet.[58][97][98] Viscous fiber supplements may be useful in those ...
Pharmacokinetics: In pre-clinical trials, it is possible to radiolabel a new drug and inject it into animals. Such scans are ... The statistics of data thereby obtained are much worse than those obtained through transmission tomography. A normal PET data ... Ontario PET Steering Committee (August 31, 2008), PET SCAN PRIMER, A Guide to the Implementation of Positron Emission ... The uptake of the drug, the tissues in which it concentrates, and its eventual elimination, can be monitored far more quickly ...
"Independent Monitoring Board Recommends Early Termination of Ebola Therapeutics Trial in DRC Because of Favorable Results with ... C.M. Fauquet (2005). Virus taxonomy classification and nomenclature of viruses; 8th report of the International Committee on ... "Clinical Microbiology Reviews (Review). 22 (4): 552-63. doi:10.1128/CMR.00027-09. PMC 2772359. PMID 19822888.. ... "Ebolavirus - Pathogen Safety Data Sheets". Public Health Agency of Canada. 17 September 2001. Archived from the original on 20 ...
42] The law encourages patient diversity in clinical trials submitted to the FDA for review. The study determined that most ... Medical monitors allow medical staff to measure a patient's medical state. Monitors may measure patient vital signs and other ... provided clinical data. Of the more than 1,100 predicate implants that the new implants were substantially equivalent to, only ... "Committee F04 on Medical and Surgical Materials and Devices". 2014. Retrieved 15 June 2014.. ...
Clinical trials were commenced for moclobemide's effectiveness in the treatment of depression.[130] It was first approved in ... Gex-Fabry, M; Balant-Gorgia, AE; Balant, LP (February 1995). "Potential of concentration monitoring data for a short half-life ... Joint Formulary Committee (2013). British National Formulary (BNF) (65 ed.). London, UK: Pharmaceutical Press. ISBN 978-0-85711 ... imipramine in bipolar depression: a multicentre double-blind clinical trial". Acta Psychiatrica Scandinavica. 104 (2): 104-109 ...
Data monitoring committees. *Directive 2001/20/EC (European Union). *Drug development. *EudraVigilance ... clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates. ... The Medicines for Human Use (Clinical Trials) Regulations 2004. *The Medicines for Human Use (Clinical Trials) Amendment ... The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the ...
They are sometimes monitored by the local government in case of defecting.[90] The San Francisco Chronicle, the Washington Post ... In 2001, members of the UK House of Commons Health Select Committee travelled to Cuba and issued a report that paid tribute to ... Randomized, placebo-controlled trial of inactivated poliovirus vaccine in Cuba. N Engl J Med. 2007 Apr 12;356(15):1536-44. Free ... Note: this source quotes data selectively and may not be reliable. Kirby Smith and Hugo Llorens. "Renaissance and decay: A ...
... clinical endpoint - clinical latency - clinical practice guidelines - clinical trial - - cloning - CMS - CMV ... DAIDS - data safety and monitoring board (DSMB) - deletion - dementia - demyelination - dendrite - dendritic cells - ... AIDS research advisory committee (ARAC) - AIDS service organization (ASO) - The AIDS Show - AIDS Vaccine 200 - AIDS Vaccine ... phase I trials - phase II trials - phase III trials - phase IV trials - photosensitivity - PHS - pituitary gland - placebo - ...
Qaseem, A; Holty, JE; Owens, DK; Dallas, P; Starkey, M; Shekelle, P; for the Clinical Guidelines Committee of the American ... Approval for this active implantable neuromodulation device was preceded by a clinical trial whose results were published in ... Monitors for airflow at the nose and mouth demonstrate that efforts to breathe are not only present but that they are often ... number and type of channels of data recorded), from lab-attended full polysomnography ("sleep study") down to single-channel ...
Clinical data. Trade names. Marinol, Syndros. Other names. (6aR,10aR)-delta-9-Tetrahydrocannabinol; (−)-trans-Δ⁹- ... Based on the results of 4 high quality trials and 4 low quality trials, oral cannabis extract was rated as effective, and THC ... "WHO Expert Committee on Drug Dependence". World Health Organization. Retrieved 12 January 2014.. ... Recreational use of cannabis is legal in many parts of North America, increasing the demand for THC monitoring methods in both ...
... a meta-analysis of published and unpublished clinical trials". Family Practice. 30 (2): 125-33. doi:10.1093/fampra/cms059. PMID ... clinical and molecular genetic data in order to explain the origin and virulence of the 1918 Spanish influenza virus". ... International Committee on Taxonomy of Viruses descriptions of:Orthomyxoviridae, Influenzavirus B and Influenzavirus C ... background for pandemic influenza vaccine safety monitoring". Vaccine. 27 (15): 2114-20. doi:10.1016/j.vaccine.2009.01.125. ...
2016). "Synbiotics for Prevention and Treatment of Atopic Dermatitis: A Meta-analysis of Randomized Clinical Trials". JAMA ... Branum AM, Lukacs SL (2008). "Food allergy among U.S. children: trends in prevalence and hospitalizations". NCHS Data Brief (10 ... National Academies Of Sciences, Engineering; Division on Earth Life Studies; Board on Agriculture Natural Resources; Committee ... and that there be a post-launch monitoring system to report adverse effects (much there exists in some countries for drug and ...
... long-term data on health of livestock fed GE foods, and human epidemiological data, the committee found no differences that ... Archived from the original on October 12, 2007 - via Holocaust Denial on Trial.. ... adequate post market monitoring, should form the basis for ensuring the safety of GM foods.. ... stressed the absence of evidence that commercially available GM foods cause clinical allergic manifestations. The BMA shares ...
... based on the recommendation of an independent data monitoring committee. Interim results showed Tasigna is unlikely to ... There is weak evidence that nilotinib may be beneficial with Parkinson's disease (PD), with a small clinical trial suggesting ... "British Journal of Clinical Pharmacology. 46 (2): 101-110. doi:10.1046/j.1365-2125.1998.00764.x. ISSN 0306-5251. PMC 1873672. ... interpretation of its effects in Parkinson's due to the significant media hype surrounding the small and early clinical trial.[ ...
A positive ANA test is seldom useful if other clinical or laboratory data supporting a diagnosis are not present.[12] ... "Guidelines for the laboratory use of autoantibody tests in the diagnosis and monitoring of autoimmune rheumatic diseases". ... Benito-Garcia, E; Schur, PH; Lahita, R; American College of Rheumatology Ad Hoc Committee on Immunologic Testing, Guidelines ( ... Findings in open-label and randomized placebo-controlled trials". Arthritis & Rheumatism. 43 (11): 2383-2390. doi:10.1002/1529- ...
The phase 2 clinical trials of the MDMA-Assisted Psychotherapy, was publicized at the end of November 2016.[258] Preliminary ... In a reanalysis of the NVVRS data, along with analysis of the data from the Matsunaga Vietnam Veterans Project, Schnurr, Lunney ... Committee on Treatment of Posttraumatic Stress Disorder, Institute of Medicine: Treatment of Posttraumatic Stress Disorder: An ... working on cognitive processes and relaxation/self-monitoring.[10] However, exposure by way of being asked to think about the ...
"Discordant Financial Conflicts of Interest Disclosures between Clinical Trial Conference Abstract and Subsequent Publication". ... This oft-quoted factoid is based on data from a World Bank/Elsevier report from 2012 which relies on data from Scopus.[note 34] ... House of Commons Business, Innovation and Skills Committee, September 2013. *^ "Journal Usage Half-Life" (PDF).. , Phil Davis, ... "Monitoring of Unauthorized Internet Posting of Journal Articles".. , American Psychological Association. *^ "Final conference ...
There is insufficient data at this time to quantify the risk, but extreme caution should be exercised if a patient has ... Although patients at high risk of bleeding were excluded from the phase III clinical study (PROWESS), 25% of patients treated ... The FDA approved the drug despite the advisory committee's split vote (10 to 10) due to concerns about the validity of the ... or other unit with very frequent observation and monitoring. ... efficacy and safety findings on the basis of a single trial. ...
Clinical data. Trade names. Toradol, Acular, Sprix, others. Other names. Ketorolac tromethamine. ... Committee on the Safety of Medicines, Medicines Control Agency: Ketorolac: new restrictions on dose and duration of treatment. ... During treatment with ketorolac, clinicians monitor for the manifestation of adverse effects. Lab tests, such as liver function ... Journal of Clinical Pharmacology. 38 (2S): 25S-35S. doi:10.1002/j.1552-4604.1998.tb04414.x. PMID 9549656. S2CID 22508540.. ...
"Data sharing platforms for de-identified data from human clinical trials". Clinical Trials: 1740774518769655. doi:10.1177/ ... This effort, carried out initially by the NIH's Advisory Committee on Computers in Research (ACCR), chaired by Lusted, spent ... patient monitoring and other applications. In the early 1980s, with the arrival of cheaper microcomputers, a great upsurge of ... Common data elements (CDEs) in clinical research[edit]. Ability to integrate data from multiple clinical trials is an important ...
This is in general not testable from the data, but if the data are known to be dependently sampled (that is, if they were ... Gosset devised the t-test as an economical way to monitor the quality of stout. The t-test work was submitted to and accepted ... Adaptive clinical trial. *Up-and-Down Designs. *Stochastic approximation. Observational Studies. *Cross-sectional study ... Committee on the Environment, Public Health and Food Safety. *India *Ministry of Health and Family Welfare ...
As of 2016[update] PARP inhibitor olaparib has shown promise in clinical trials for CRPC.[185] Also in trials for CRPC are : ... PI-RADS is an acronym for Prostate Imaging-Reporting and Data System, defining standards of high-quality clinical service for ... Active surveillance involves monitoring the tumor for signs of growth or the appearance of symptoms. The monitoring process may ... A Guidance Statement From the Clinical Guidelines Committee of the American College of Physicians". Annals of Internal Medicine ...
The amount of folic acid used in this clinical trial - 2,500 μg/day - was higher than the tolerable upper intake level of 1,000 ... These data indicate that since the addition of folic acid in grain-based foods as mandated by the FDA, the rate of neural tube ... In the U.S., there is concern that the federal government mandates fortification but does not provide monitoring of potential ... set by the Committee on Medical Aspects of Food and Nutrition Policy (COMA) in 1991, is 200 μg/day for adults.[64] ...
Based on the data collected, the social conditions such as education, income, and race were dependent on one another, but these ... The review of 21 studies, including 16 randomized controlled trials, found that unconditional cash transfers may not improve ... the World Health Organization and United Nations Children's Fund called for the monitoring of intersectoral interventions on ... "Structural Violence and Clinical Medicine". PLoS Medicine. 3 (10): e449. doi:10.1371/journal.pmed.0030449. PMC 1621099. PMID ...
... "a single clinical trial can cost $100 million at the high end, and the combined cost of manufacturing and clinical testing for ... In 2003, data from the Medical Expenditure Panel Survey showed that only 9.5% of Americans with Medicare coverage had no ... US Senate Special Committee on Aging. Collins, McCaskill open Senate investigation into Rx drug pricing, announce intention to ... requiring special monitoring, follow-up, or administration technique or assistance).[21] The number of specialty ...
Quality of clinical trialsEdit. This section does not cite any sources. Please help improve this section by adding citations to ... Committee to Advise the Public Health Service on Clinical Practice Guidelines, Institute of Medicine (1990). Field, M.J.; Lohr ... Trial design considerations. High-quality studies have clearly defined eligibility criteria and have minimal missing data. ... and guidelines for the use of the BCLC staging system for diagnosing and monitoring hepatocellular carcinoma in Canada.[63] ...
A systematic review of randomised controlled trials". Clinical Otolaryngology. 40 (3): 197-207. doi:10.1111/coa.12344. PMID ... It was concluded that the data were insufficient to decide if this therapy has positive effects.[34][35] ... The American Academy of Otolaryngology-Head and Neck Surgery Committee on Hearing and Equilibrium (AAO HNS CHE) set criteria ... and a hospital stay of a few days for monitoring would be required.[29] ...
"European Journal of Clinical Nutrition. 66 (7): 780-8. doi:10.1038/ejcn.2012.37. PMC 3392894 . PMID 22510792.. ... Amino acid content of foods and biological data on proteins (FAO nutritional studies number 24). Food and Agriculture ... The recommendation is not to limit intake of meats or protein, but rather to monitor and keep within daily limits the sodium ... Nutrition for Athletes, International Olympic Committee Nutrition Working Group of the Medical and Scientific Commission of the ...
... the committee monitoring response variables is not told the identity of the groups. The committee is simply given data for ... Friedman, L.M., Furberg, C.D., DeMets, D.L. (2010). Fundamentals of Clinical Trials. New York: Springer, pp. 119-132. ISBN ... However, in a trial where the monitoring committee has an ethical responsibility to ensure participant safety, such a design ... In addition, by the time many monitoring committees receive data, often any emergency situation has long passed.[12] ...
A meta-analysis of individual patient data from randomized trials". American Journal of Respiratory and Critical Care Medicine ... the authors noted that as of the date of their article over 150 clinical trials of sepsis had been conducted in humans, almost ... After six hours the blood pressure should be adequate, close monitoring of blood pressure and blood supply to organs should be ... The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine) (June ...
... the independent Data Monitoring Committee overseeing the Companys ongoing pivotal Phase 3 clinical trial evaluating Firdapse™ ... recommended that the trial be continued as planned based on the committees review of safety and clinical data from the trial. ... the independent Data Monitoring Committee (DMC) overseeing the Companys ongoing pivotal Phase 3 clinical trial evaluating ... recommended that the trial be continued as planned based on the committees review of safety and clinical data from the trial. ...
Asterias Biotherapeutics Announces Data Monitoring Committee Unanimously Recommends Continuation Of Scistar Phase I/IIa ... Clinical Trial Of AST-OPC1 For Cervical Spinal Cord Injury - read this article along with other careers information, tips and ... biotherapeutics-announces-data-monitoring-committee-unanimously-recommends-continuation-of-scistar-phase-12a-clinical-trial-of- ... Biotherapeutics Announces Data Monitoring Committee Unanimously Recommends Continuation Of Scistar Phase I/IIa Clinical Trial ...
Data Monitoring Committee Unanimously Recommends Continuation Of Combioxin First-In-Human Clinical Trial With CAL02 In Patients ... Combioxin Release: Data Monitoring Committee Unanimously Recommends Continuation Of Combioxin First-In-Human Clinical Trial ... The Independent Data Monitoring Committee has reviewed the safety data from a first set of patients treated with a High Dose of ... that an Independent Data Monitoring Committee has unanimously recommended continuation of the ongoing first-in-human trial in ...
Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition Susan S. Ellenberg, Thomas R. Fleming, ... Statistical Analysis with Missing Data, 3rd Edition Roderick J. A. Little, Donald B. Rubin ...
Randomized clinical trials are increasingly overseen by independent data monitoring committees (DMCs) that monitor trial ... Data and safety monitoring; Data monitoring committee; DMC; Research oversight; Biostatistics; Clinical informatics; Clinical ... Recommendations from the Clinical Trials Transformation Initiatives Data Monitoring Committee Project Presenters. Karim Anton ... The Clinical Trials Transformation Initiative (CTTI) established the Data Monitoring Committees project team to study the roles ...
Independent Data Monitoring Committees in Clinical Trials. This course will teach you the statistical display and analysis ... This certificate program covers the skills needed to gather, analyze, and assess data for activities like clinical trials, ... This course teaches you clinical trial designs including randomized controlled trials, ROC curves, CI and tests for relative ... methods used in monitoring clinical trials for safety, as well as the biases and pitfalls inherent in safety review. ...
... to our knowledge this premise has never been tested via a prospective randomized clinical trial. Eligible patients will have ... Before randomization, two clinically-approved radiotherapy plans will be devised for all patients on trial, termed standard and ... This randomized, double-blind trial will comprehensively assess the impact of functional lung avoidance on pulmonary toxicity ... Data safety monitoring committee. The data safety monitoring committee (DSMC) will consist of a statistician, an independent ...
... written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the ... This is the fifth edition of a very successful textbook on clinical trials methodology, ... two specifically on data monitoring. He has served on many NIH and industry-sponsored data monitoring committees for clinical ... and operational responsibilities for many clinical trials in cardiology. He has been on numerous Data Monitoring Committees. He ...
This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have ... two specifically on data monitoring. He has served on many NIH and industry-sponsored data monitoring committees for clinical ... and operational responsibilities for many clinical trials in cardiology. He has been on numerous Data Monitoring Committees. He ... Trial. Dr. Reboussin has served on the Data and Safety Monitoring Boards for many National Institutes of Health trials within ...
Data monitoring committees for pragmatic clinical trials.. Ellenberg SS, Culbertson R, Gillen DL, Goodman S, Schrandt S, Zirkle ... On the Use of Local Assessments for Monitoring Centrally Reviewed Endpoints with Missing Data in Clinical Trials. ... Attitudes toward clinical trials across the Alzheimers disease spectrum.. Nuño MM, Gillen DL, Dosanjh KK, Brook J, Elashoff D ... Flexibly Monitoring Group Sequential Survival Trials When Testing is Based Upon a Weighted Log-Rank Statistic. ...
Has Data Monitoring Committee No. U.S. FDA-regulated Product Not Provided. ... With respect to the latter, the recent Gilead 903 trial has been very informative in the sense that no limb fat wasting ( ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ... Includes publications given by the data provider as well as publications identified by Identifier (NCT ...
Has Data Monitoring Committee Yes U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No. ... The trial is supported by the French program of clinical research and the national health insurance. Two associated studies are ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ... Includes publications given by the data provider as well as publications identified by Identifier (NCT ...
Has Data Monitoring Committee No. U.S. FDA-regulated Product Not Provided. ... Double-blind placebo-controlled trial of fluoxetine in adolescents with comorbid major depression and an alcohol use disorder. ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ... Includes publications given by the data provider as well as publications identified by Identifier (NCT ...
Has Data Monitoring Committee Not Provided. U.S. FDA-regulated Product Not Provided. ... Includes publications given by the data provider as well as publications identified by Identifier (NCT ... A PHASE I TRIAL OF HIGH DOSE CHEMOTHERAPY WITH AUTOLOGOUS BONE MARROW AND PERIPHERAL BLOOD PROGENITOR CELL RESCUE IN PATIENTS ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ...
Has Data Monitoring Committee Yes. U.S. FDA-regulated Product Not Provided. ... NCI-2016-00534 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ). I 270715 ( Other Identifier: Roswell Park ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ... I. To obtain pilot data on clinical response rates using both Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 ...
Almost all clinical trials have a control arm. Data Monitoring Committee (DMC): An independent panel that monitors the study ... Periodically, a Data Monitoring Committee (DMC) will review the data from the trial to determine if the trial is worth ... The Four Phases of Clinical Trials. *Phase I clinical trials are the first step in human testing. Prior to Phase I, treatments ... Clinical Trials: Making Them Work for You. Clinical Trials: Out of the Laboratory and Into the Bathroom Cabinet: Designing and ...
Has Data Monitoring Committee No U.S. FDA-regulated Product Not Provided ... Trial record 1 of 1 for: NCT02598206 Previous Study , Return to List , Next Study ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ... Includes publications given by the data provider as well as publications identified by Identifier (NCT ...
... to Review and Evaluate Patient Safety and Efficacy Data for Pivotal Phase 3 Trial of Galinpepimut-S in Patients... ... to Review and Evaluate Patient Safety and Efficacy Data for Pivotal Phase 3 Trial of Galinpepimut-S in Patients... ... Independent Data Monitoring Committee of Leading Clinical and Biostatistics Experts for Pivotal Phase 3 REGAL Clinical Trial. ... Independent Data Monitoring Committee (DMC) to Review and Evaluate Patient Safety and Efficacy Data for Pivotal Phase 3 Trial ...
p,,i,Trials,/i, is dedicated to improving the design, conduct and reporting of randomised controlled trials in health. Edited ... we consider articles assessing aspects of the performance or findings of trials, including general trial methodology, ... innovative approaches to improving communication about trials.,/p, ... Remits, roles and working models for trial steering committees and data monitoring committees in studies evaluating diagnostic ...
"Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees" (PDF). Food and ... "Data Monitoring Committees in Practice: Tips on using DMCs to improve trial efficiency and safety". Applied Clinical Trials. ... A data monitoring committee (DMC) - sometimes called a data and safety monitoring board (DSMB) - is an independent group of ... Data and Safety Monitoring Committees in Clinical Trials, Chapman & Hall/CRC, ISBN 978-1-4200-7037-8 David Kerr; Lynn Shemanski ...
Has Data Monitoring Committee No U.S. FDA-regulated Product Not Provided ... Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find ... Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative ... Participation in a clinical trial with an investigational drug during the 30 days. prior to enrolment in the study. ...
Has Data Monitoring Committee Not Provided U.S. FDA-regulated Product Not Provided ... Interested in learning more about clinical trials?. Discover how clinical trials work and the impact your participation could ... Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find ... Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative ...
... the trial advisory group; Trent MREC, David Shapiro, and the training reference group; Mike Campbell and the data monitoring ... and ethics committee; Tom Ricketts, Keith Tudor, and Chris Williams for their training input; Robin Smith, GIS Analyst; and ... Clinical management and service guidance. London: National Institute for Health and Clinical Excellence, 2007. ... Clinical effectiveness.... *Clinical effectiveness of health visitor training in psychologically informed approaches for ...
Update on Phase 3 Clinical Trials of Lanabecestat for Alzheimers Disease Independent data monitoring committee advises ... Update on Phase 3 Clinical Trials of Lanabecestat for Alzheimers Disease. Independent data monitoring committee advises ... The decision is based on recommendations by an independent data monitoring committee (IDMC) which concluded that both the ... Update on Phase 3 Clinical Trials of Lanabecestat for Alzheimers Disease. PRNewswire {{following ? "Following" : "Follow"}} ...
Has Data Monitoring Committee No. U.S. FDA-regulated Product Not Provided. ... Includes publications given by the data provider as well as publications identified by Identifier (NCT ... Be able to provide written consent to perform in the trial.. *HIV antibody negative and HIV DNA negative at time of entry to ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ...
Independent Data Monitoring Committees in Clinical Trials This course will teach you the statistical display and analysis ... This course will teach you clinical trial designs including randomized controlled trials, ROC curves, CI and tests for relative ... methods used in monitoring clinical trials for safety, as well as the biases and pitfalls inherent in safety review. ... Clinical Trials - Phamacokinetics and Bioequivalence This course will teach you the statistical measurement and analysis ...
Data Monitoring Committees in Clinical Trial. Dec. 3. Jihnhee Yu, PhD. Designs & Challenges Using The Registry Data. ... Help us to continue your research by citing in your publication the Clinical and Translational Science Award [UL1TR001412 or ... Clinical and Translational Science Institute. Advancing research discoveries to improve health for all ... Attendees will use this knowledge to formulate well-defined clinical and translational research questions, and to incorporate ...
2003) Data Monitoring Committees in Clinical Trials: A Practical Perspective (Wiley, Chichester, United Kingdom).. ... That clinical trials are required to have independent data and safety monitoring boards (2) with the power to review partial ... After a clinical trial is over, the ethical nuances and the unrecorded discussions of its safety monitoring boards are ... 2006) in In Handbook of Statistics in Clinical Oncology, Early stopping of cancer clinical trials, eds Crowley J, Ankerst DP ( ...
Enhancing trial integrity by protecting the independence of data monitoring committees in clinical trials. J Biopharm Stat 2014 ... Data sharing among data monitoring committees and responsibilities to patients and science. Trials 2013; 14: 102. ... A trial data safety and monitoring committee is in the unique position of being able to review safety information according to ... NHMRC Australian Health Ethics Committee (AHEC) position statement. Monitoring and reporting of safety for clinical trials ...
13:50 A PRACTICAL GUIDE TO DATA MONITORING COMMITTEES. Alex Bajamonde, Director, Early & Business Development, DATA Group, ... Running a trial adaptively can sometimes seem like the established clinical trial "play book" has to be stood on its head. ... Biostatistics, Clinical R&D, Medical Affairs, Clinical Operations, Clinical Supplies, Data Management, Portfolio Management, ... 14:30 BAYESIAN ADAPTIVE NON-INFERIORITY DESIGN WITH SAFETY ASSESSMENT: RETROSPECTIVE ANALYSIS OF CLINICAL TRIAL DATA. ...
  • Randomized clinical trials are increasingly overseen by independent data monitoring committees (DMCs) that monitor trial conduct and safety and make recommendations for trial changes. (
  • Responsibilities of DMCs can include reviewing data quality, trial operations, and ethical oversight. (
  • The Clinical Trials Transformation Initiative (CTTI) established the Data Monitoring Committees project team to study the roles and responsibilities of DMCs and to develop recommendations on their composition, communication among members and other stakeholders, establishing a charter, and issues related to DMC training. (
  • This comprehensive training package of four courses covers clinical trial monitoring techniques, audit procedures and the setting-up of Data Monitoring Committees (DMCs). (
  • and setting up effective Data Monitoring Committees (DMCs). (
  • This Data Monitoring Committees (DMCs) training for Clinical Research teaches why the increase in using DMCs in Clinical Research affects subject-public safety and hos can they be set up to be effective. (
  • and factors associated with use of randomization, blinding, and data monitoring committees (DMCs). (
  • Clinical trials registered in are dominated by small trials and contain significant heterogeneity in methodological approaches, including reported use of randomization, blinding, and DMCs. (
  • [4] This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs) or Data andSafety Monitoring Committees (DSMCs)) that may carry out important aspects of clinical trial monitoring. (
  • Best practices of Data Monitoring Committees (DMCs) in randomized clinical trials are well established. (
  • Independent oversight provided by DMCs is particularly important in trials conducted in public health emergencies, such as in HIV/AIDS or coronavirus epidemics. (
  • The DMC is a group of experts responsible for the independent review of accumulated clinical safety and efficacy data obtained in the Company's clinical trial, in order to safeguard the interests and safety of participants and future patients. (
  • The international, multicenter Firdapse™ Phase 3 clinical trial is designed as a randomized, double-blind, placebo-controlled, discontinuation trial enrolling 36 patients diagnosed with LEMS. (
  • Based on their review of all the available study data, the DMC has concluded that AST-OPC1 is safe for acute spinal cord injury patients and that the SCiStar study is being conducted according to the highest clinical research standards. (
  • The review included the safety data from six complete cervical injury (AIS-A) patients dosed with 10 million AST-OPC1 cells in Cohort 2, each of whom have completed at least six months of follow-up, as well as initial safety data from the currently enrolling Cohorts 3 and 4. (
  • In addition, the DMC reviewed the ongoing long-term safety data from the study's initial cohort of three patients dosed with 2 million cells, all of whom completed 12 months of follow-up in 2016. (
  • The results suggest a meaningful and favorable difference to date in recovery of arm, hand and finger function in patients treated with the 10 million cell dose of AST-OPC1 as compared to the level of expected rates of spontaneous recovery shown from historical control data of a closely matched patient population. (
  • The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with sub-acute, C-5 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. (
  • 10 October 2017 - Combioxin SA, a Swiss-based company specialising in the treatment of severe bacterial infections, announced today that an Independent Data Monitoring Committee has unanimously recommended continuation of the ongoing first-in-human trial in severely infected patients and High Dose continuation CAL02. (
  • The Independent Data Monitoring Committee has reviewed the safety data from a first set of patients treated with a High Dose of CAL02 in the randomized, multicentre, double-blind, placebo-controlled CAL02-001 trial in patients with severe pneumococcal pneumonia and concluded that results support a positive safety profile for CAL02 at High Dose. (
  • Use of a DMC can enhance the credibility of trials among both patients and clinicians. (
  • Before randomization, two clinically-approved radiotherapy plans will be devised for all patients on trial, termed standard and avoidance . (
  • This randomized, double-blind trial will comprehensively assess the impact of functional lung avoidance on pulmonary toxicity and quality of life in patients receiving concurrent CRT for locally advanced NSCLC. (
  • The DMC will review study data at regular intervals in order to ensure the safety of all patients enrolled in the study. (
  • With the formation of the DMC, comprised of highly regarded and experienced physicians and biostatisticians who will confer with the respected physicians on the Steering Committee recently announced, we believe that we have brought together world class experts to monitor and guide this critical study which has the potential to extend the life of AML patients in CR2," said Angelos Stergiou, MD, ScD h.c. (
  • Because those patients are by definition in a remission, risk and benefit must be very carefully balanced and it is of great scientific interest to me to be a part of that process, as GPS may have the potential to prolong survival, as the Chair of the independent data monitoring committee for the study focused specifically on that patient population. (
  • It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. (
  • Which MCI Patients Should be Included in Prodromal Alzheimer Disease Clinical Trials? (
  • PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with carboplatin and cyclophosphamide followed by bone marrow and peripheral stem cell transplantation in treating patients who have advanced ovarian epithelial cancer. (
  • This phase II trial studies the combination of pembrolizumab, bevacizumab, and low dose oral cyclophosphamide in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. (
  • Clinical trials are studies designed to test treatment safety and efficacy in patients. (
  • Researchers rely on volunteer patients to fill these trials. (
  • A clinical trial might follow patients' diets, or a holistic therapy or a vaccine. (
  • Clinical research depends on patients wanting to get involved in the system. (
  • In Phase I trials, patients are usually given very short doses of the trial treatment to see the effects. (
  • Accordingly, patients are heavily monitored. (
  • These trials follow a large number of patients over a long period of time. (
  • Clinical trials are the primary method for patients to legally receive medications that have not yet been approved by the Food and Drug Administration. (
  • Clinical trials offer the opportunity for some patients to receive these medications free of charge. (
  • Patients in clinical trials also often receive additional attention from health-care providers. (
  • The patients are not supposed to participate to any other trial during all the study period. (
  • The AMARANTH trial randomized patients with early Alzheimer's disease to receive lanabecestat, 20mg or 50mg, or placebo orally once daily for 104 weeks. (
  • Patients who completed the AMARANTH trial were given the opportunity to enroll in the AMARANTH extension trial, where all patients received active treatment. (
  • CLSN ), a leading oncology drug development company, announced that after reviewing data from 401 patients enrolled in its pivotal Phase III ThermoDox ® clinical study (the HEAT study) for primary liver cancer, the Data Monitoring Committee (DMC) has unanimously recommended that the trial continue to enroll patients with the goal of reaching the 600 patients required to complete the study. (
  • ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, is currently being evaluated under a Special Protocol Assessment (SPA) agreement with the FDA in this global Phase III trial in patients with non-resectable hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. (
  • With nearly 75% of patients enrolled in the trial, Celsion is targeting to complete patient enrollment over the next 4 months. (
  • The DMC reviews study data at regular intervals with their primary responsibilities to ensure the safety of all patients enrolled in the trial, the quality of the data collected, and the continued scientific validity of the trial design. (
  • We are very pleased that the DMC has unanimously recommended continuation of the HEAT study based on its review of all available clinical data, both safety and efficacy, in over 400 patients," stated Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer. (
  • For randomized clinical trials, adaptive assignment strategies are known to expose substantially fewer patients to avoidable treatment failures than strategies with fixed assignments (e.g., equal sample sizes). (
  • Although they seek to demonstrate an intervention's effectiveness at a high level of statistical significance, randomized trials will always assign some patients to an inferior treatment and they will often assign patients to a treatment for which there is already partial evidence of its inferiority. (
  • However, as health outcomes research enabled by electronic medical records becomes common ( 6 ), comparative effectiveness research (CER), which is logically, if not by name, a kind of clinical trial ( 7 ), will extend the duration of ethical questions, and the number of patients affected by such questions, almost without bound. (
  • In response-adaptive trials, partial data inform not just "circuit-breaker" early stopping decisions, but also affect, by defined statistical protocols, such things as the assignment of patients to treatments, dosages, and so forth. (
  • In a clinical trial, patients are assigned in turn to one or the other treatment. (
  • The article reports that Taxotere as Adjuvant ChemoTherapy (TACT) has explored the question of if and how patients should be told of the results of clinical trials in which they participate. (
  • The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study. (
  • IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials, especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time. (
  • This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements with respect to Multikine and the Phase 3 clinical trial of Multikine in patients with advanced primary squamous cell carcinoma of the head and neck. (
  • Although the report of the streptomycin trial is rightly iconic, the attention it has attracted has led many historians to overlook earlier evidence relevant to the evolution of unbiased prospective allocation of patients to treatment comparison groups. (
  • In fact, for half a century before the MRC trial and Fisher's writings, some medical practitioners wishing to evaluate the effects of treatments had used alternate allocation to assemble similar groups of patients, and so ensure that like would be compared with like. (
  • Al-Chalabi A, Shaw PJ, Young CA et al (2011) Protocol for a double-blind randomized placebo-controlled trial of lithium carbonate in patients with amyotrophic lateral sclerosis (LiCALS) (Eudract number: 2008-006891-31). (
  • As the application process is competitive - multiple teams compete to be commissioned to answer a single question - it might be expected that applicants overestimate their ability to recruit patients to trials, in order to make their applications appear more attractive. (
  • We undertook a retrospective analysis of 306 patients with lower-grade gliomas accrued from an institutional data base and The Cancer Genome Atlas. (
  • The RIAT authors also considered the individual data in the case report forms for the Kiddie SADS scores and HAM-D data scores to confirm suicidal behaviour for these patients (see Table 1). (
  • CHMP/EWP/83561/05: Clinical trials in small populations [6] (EMA) addresses problems associated with clinical trials when there are limited numbers of patients available to study. (
  • In conclusion, rVIII-SingleChain is a novel rFVIII molecule showing excellent hemostatic efficacy in surgery and in the control of bleeding events, low ABR in patients on prophylaxis, and a favorable safety profile in this large clinical study. (
  • The study is a prospective, single arm, non-randomized, open label phase II trial, designed to study the safety and efficacy of a medical device, the NovoTTF-100L concomitant with Pemetrexed and cisplatin or carboplatin in Malignant Pleural Mesothelioma patients. (
  • Recurrent GBM patients treated with TTFields in this trial experienced fewer side effects in general, significantly fewer treatment related side effects, and significantly lower gastrointestinal, hematological and infectious adverse events compared to controls. (
  • Recently, an interim analysis of a large ongoing phase III trial in newly diagnosed GBM showed that adding TTFields to the standard of care temozolomide chemotherapy significantly prolonged patients' progression free survival and overall survival. (
  • The FDA approved cross over of control arm patients to the TTFields arm of the trial. (
  • All patients included in this trial are diagnosed with malignant pleural mesothelioma. (
  • An IDMC is an independent panel of experts who periodically review clinical trial data to ensure that the interests of the patients are being well-served and that the scientific integrity of the trial is maintained. (
  • This is very positive feedback on OBE022, a potential first-in-class molecule being developed for the treatment of preterm labor, and we continue progressing towards the completion of the trial with the next IDMC review expected with data from 60 patients later this year. (
  • The trial will recruit 120 patients with preterm labor at a gestational age of 24 to 34 weeks. (
  • More episodes of DKA and fewer episodes of documented and severe hypoglycemia were observed in patients using sotagliflozin relative to those receiving placebo ( , NCT02421510 ). (
  • Malar rashes have been reported to be present in up to 52% of SLE patients at the time of diagnosis, with clinical activity of the rash paralleling that of the systemic disease. (
  • Consequently, we developed a checklist of recommendations and a pathway for clinicians to enable clinical decision making and illustrate the treatment journey with patients," Jankowski said. (
  • Finally, they recommend that more data are needed from the Aspirin Esomeprazole Chemoprevention Trial (AspECT) and chemopreventive trials of proton pump inhibitors in patients with BE. (
  • The Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial is a multicenter, prospective, randomized, allocation concealed, double-blind, placebo-controlled clinical trial which aims to test the hypothesis that treatment with simvastatin will improve clinical outcomes in patients with ALI. (
  • Data will be recorded by participating ICUs until hospital discharge, and surviving patients will be followed up by post at 3, 6 and 12 months post randomization. (
  • NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holdings AG (OTC:RLFTF, SIX:RLF) today announced that the independent Data Monitoring Committee has reviewed the findings in the first 30 patients treated in Fast Track FDA trials of RLF-100 (Aviptadil) in patients with Critical COVID-19 with respiratory failure. (
  • The Relief group of companies focus primarily on clinical-stage projects based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rational. (
  • Methods Treatment-emergent adverse events (TEAEs) and laboratory data from five randomised, placebo- or active-controlled phase III trials of upadacitinib for patients with RA were analysed and summarised. (
  • Conclusion In the phase III clinical programme for RA, patients receiving upadacitinib had an increased risk of herpes zoster and CPK elevation versus adalimumab. (
  • The TAPPAS trial was designed to compare treatment with TRC105 and Votrient to treatment with single agent Votrient in up to 340 patients with advanced or metastatic angiosarcoma. (
  • The ophthalmic formulation of TRC105, DE-122, is currently being studied in the randomized Phase 2 AVANTE trial in patients with wet AMD. (
  • DE-122 is being investigated in the Phase 2 randomized AVANTE trial assessing the efficacy and safety of intravitreal injections in combination with Lucentis ® (ranibizumab) compared to Lucentis monotherapy in patients with wet AMD. (
  • But it would take seven years of clinical trials with solid findings before the U.S. Food and Drug Administration (FDA) approved the drug for the treatment of cancer patients with pancreatic neuroendocrine tumors (pNET). (
  • There are safeguards that govern clinical trials and protect patients. (
  • Concern about the use of epinephrine as a treatment for out-of-hospital cardiac arrest led the International Liaison Committee on Resuscitation to call for a placebocontrolled trial to determine whether the use of epinephrine is safe and effective in such patients. (
  • Design, setting, participants, & measurements This is a randomized, open-label Phase II trial in renal transplant patients with stable graft function and receiving a CNI-based regimen. (
  • The clinical trial enrolled 462 patients who received the immunotherapy along with the drug sunitinib (Sutent), the standard of care for the cancer. (
  • The primary goal of the trial was improving overall survival of patients. (
  • Duke's IRB also monitors studies while patients are treated, looks for unexpected side effects, and guarantees patients are treated correctly and safely. (
  • Enrolling patients in clinical trials, monitoring them and evaluating their progress and clinical trials. (
  • Intravitreal triamcinolone is superior to observation for treating vision loss associated with macular edema secondary to CRVO in patients who have characteristics similar to those in the SCORE-CRVO trial. (
  • Intravitreal triamcinolone in a 1-mg dose, following the retreatment criteria applied in the SCORE Study, should be considered for up to 1 year, and possibly 2 years, for patients with characteristics similar to those in the SCORE-CRVO trial. (
  • However, a new agent called TH-302 has not only yielded positive phase II data, but its phase III study also has recently been expanded to include more patients to meet the enrollment demand. (
  • Van der Graaf et al reported at the European Society for Medical Oncology (ESMO) 2012 Congress that patients with soft-tissue sarcoma who received doxorubicin alone in a phase III trial achieved a median PFS of 4.6 months and an OS of 12.8 months. (
  • Pfizer Inc announced that a phase 3 clinical trial of Sutent (sunitinib malate) has been stopped early after the drug showed significant benefit in patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors. (
  • An independent Data Monitoring Committee (DMC) recommended halting the trial after concluding that Sutent demonstrated greater progression-free survival compared to placebo plus best supportive care in patients with pancreatic islet cell tumors. (
  • We are delighted by these findings which demonstrate that Sutent provides a benefit for patients with advanced, well-differentiated pancreatic islet cell tumors - a rare cancer with limited treatment options," said Dr. Mace Rothenberg, senior vice president of medical development and clinical affairs for Pfizer's Oncology Business Unit. (
  • These and previously reported phase 2 data contribute to the growing body of evidence indicating activity with sunitinib in patients with pancreatic islet cell tumors. (
  • All patients in the trial will have the option to continue taking Sutent or be switched from placebo to Sutent. (
  • This phase III trial of sunitinib in patients with advanced pancreatic islet cell tumors was initiated based on the results of a earlier phase II trial published in the Journal of Clinical Oncology (July 2008). (
  • To date, more than 38,000 patients globally have been treated with Sutent in the clinical setting and trials. (
  • After reviewing data on the first 60 patients, an independent committee monitoring the study recommended that the clinical trial continue without changes. (
  • Meeting with Food and Drug Administration Remains on Track for End of 2018 FREMONT, Calif., Oct. 31, 2018 (GLOBE NEWSWIRE) -- Asterias Biotherapeutics, Inc. (NYSE American: AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, today announced a positive outcome from an independent Data Review Panel's review of the data generated by patients enrolled in the C. (
  • CLOTS was a family of multicentre randomised controlled trials testing external compression devices (e.g.stockings and intermittent pneumatic compression) for deep vein thrombosis (DVT) prevention in acute stroke patients. (
  • The data indicated that stockings do not reduce the risk of clots ( DVT ) in patients admitted to hospital with a stroke. (
  • The second CLOTS trial investigated whether long graduated compression stockings reduced the risk of developing a deep vein thrombosis (DVT) compared to short knee-length graduated compression stockings in patients admitted with a stroke. (
  • The trial found that proximal DVT occurs more often in patients with stroke who wear below-knee stockings than in those who wear thigh-length stockings. (
  • The data showed that IPC reduced the risk of DVT by about a third compared with the risk in patients who received routine care only. (
  • Which stroke patients gain most from intermittent pneumatic compression: further analyses of the CLOTS 3 trial. (
  • Design Prospective cluster trial randomised by general practice, with 18 month follow-up. (
  • Pragmatic, investigator-initiated Phase IV clinical trials of post-marketed drugs or devices are needed to understand their role in everyday clinical practice. (
  • Data Monitoring Committees in Practice. (
  • The website directs visitors to a British Medical Journal video made in 2009, in which Colin Blakemore, a neurophysiologist and former MRC Chief Executive, speaks to John Crofton (a pioneer of tuberculosis trials) and me about how randomization and blinding in clinical trials has helped to generate reliable evidence to inform clinical practice. (
  • ICH E6(R2): Good clinical practice [1] is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. (
  • FDA: Good Review Practice: Clinical Review of Investigational New Drug Applications. (
  • [2] This good review practice (GRP) document was prepared to assist FDA clinical review staff in reviewing clinical submissions to an investigational new drug application (IND) from the pre-IND phase to the time of the pre-new drug application/biologics license application meeting. (
  • The BOB CAT group, therefore, used an evidence-based Delphi process to review more than 20,000 papers and provide recommendations to inform clinical practice for a global audience. (
  • Secondary outcomes were mean Edinburgh postnatal depression scale, clinical outcomes in routine evaluation-outcome measure (CORE-OM), state-trait anxiety inventory (STAI), SF-12, and parenting stress index short form (PSI-SF) scores at six, 12, 18 months. (
  • As electronic medical records enable increasingly ambitious studies of treatment outcomes, ethical issues previously important only to limited clinical trials become relevant to unlimited whole populations. (
  • The aim of this study is to assess whether research outcomes affect the dissemination of clinical trial findings, in terms of rate, time to publication, and impact factor of journal publications. (
  • We extracted data on journal and year of publication, reporting of methods and funding, planned sample size, number and planning of interim analyses, stopping rules, and effect size of the harm outcomes. (
  • The primary harm outcomes reported across trials included toxicity, death, and increased mother-to-child transmission. (
  • Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. (
  • Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the "progesterone" group having a lower incidence of preterm birth. (
  • Plasma and urine samples will be taken up to day 28 to investigate potential mechanisms by which simvastatin might act to improve clinical outcomes. (
  • An evaluation of constrained randomization for the design and analysis of group-randomized trials with binary outcomes. (
  • The decision is based on recommendations by an independent data monitoring committee (IDMC) which concluded that both the AMARANTH trial, in early Alzheimer's disease, and the DAYBREAK-ALZ trial, in mild Alzheimer's disease dementia, were not likely to meet their primary endpoints upon completion and therefore should be stopped for futility. (
  • Defined trial endpoints do not need to be reported as safety events (because they are being properly monitored and analysed). (
  • FDA: Clinical trial endpoints for the approval of cancer drugs and biologics [17] provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications. (
  • Efficacy endpoints were remarkably high compared to historical data for pemetrexed alone. (
  • Dr. Furberg's research activities include the areas of clinical trials methodology and cardiovascular epidemiology. (
  • The trial is supported by the French program of clinical research and the national health insurance. (
  • As these trials generally look at standard of care treatments, the involvement from the patient is not much different from non-research treatment. (
  • It was agreed that Lilly would lead clinical development, working with researchers from AstraZeneca's Research and Development Team, while AstraZeneca would be responsible for manufacturing. (
  • Attendees will use this knowledge to formulate well-defined clinical and translational research questions, and to incorporate regulatory precepts into the design of future studies. (
  • Help us to continue your research by citing in your publication the Clinical and Translational Science Award [UL1TR001412 or KL2TR001413] to the University at Buffalo from the NIH National Center for Advancing Translational Sciences. (
  • Unfortunately, in Australia there is clear evidence of ever-increasing requirements from sponsors and ethics committees to report AEs and SAEs unnecessarily, leading to a decrease in the uptake of research, particularly less well funded investigator-initiated trials. (
  • Clinical research is undertaken to elucidate such benefits, but also to identify potential harms. (
  • 3 Such guidelines are practical steps to ensure safety for participants in all research involving interventions, including post-marketing surveillance and Phase IV trials ( Box 2 ) of approved medicines, treatments and devices. (
  • Unfortunately, in Australia there are ever-increasing complexities and burdensome requirements from sponsors and human research ethics committees (HRECs) to report everything without necessarily paying heed to the principles outlined in the guidance documents. (
  • The increased burden on investigators and research coordinators is increasing the workload and costs of clinical trials, 4 and decreasing opportunities for trial recruitment and participation of centres at the local level. (
  • This has led to a decrease in the uptake of research, particularly less well funded investigator-initiated trials. (
  • Role of the research and clinical nurse in the trials. (
  • The spatial structure of health and environmental data presents special opportunities and challenges in public health research. (
  • Over 35 of the FDA's most crucial guidances on clinical research have been compiled for you. (
  • The detailed and exceptionally clear 1948 report of the British Medical Research Council's randomised trial of streptomycin for pulmonary tuberculosis is rightly regarded as a landmark in the history of clinical trials ( MRC 1948 ). (
  • UK Medical Research Council and multicentre clinical trials: from a damning report to international recognition. (
  • Surprisingly, the MRC itself has been curiously silent about the enduring value of its role in developing clinical trial methods, and about the important methodological legacy left by the director of its Statistical Research Unit - Austin Bradford Hill. (
  • Furthermore, reference to the important emergence of multicentre controlled trials is recognised in just two lines (Scadding 2000) in the 83-page report of a Wellcome Witness Seminar on clinical research in Britain between 1950 and 1980 (Reynolds and Tansy 2000). (
  • Research by Desirée Cox-Maximov ( 1997 ), Ben Toth ( 1998 ), Martin Edwards ( 2004 ) and Keith Williams ( 2005 ) helps to explain the Council's lack of interest in controlled clinical trials during the 1930s. (
  • More research is needed to gather relevant data and understand the MRC's continuing lukewarm celebration of its role in developing clinical trial methods. (
  • Large scale multicentre randomised controlled trials (RCTs) are regarded as the gold standard in rigorous, robust clinical research. (
  • As the leading public funder of clinical trials in the United Kingdom, the NIHR Health Technology Assessment (HTA) programme has an interest in optimising its investment in trials - and one way in which it can do this is by ensuring good estimates of timescales for research are available at the time of taking funding decisions. (
  • Clinical trials are research studies that aim to determine whether a medical strategy, treatment or device is safe for use or consumption by humans. (
  • A clinical trial research team may consist of doctors, nurses, social workers, health care professionals, scientists, data managers and clinical trial coordinators. (
  • The intention of clinical trials is predominantly one of research. (
  • Clinical trials on humans occur in the concluding stages of a long, systematic and thorough research process. (
  • Carol Owen, has been in the Clinical Research Industry for over 20 years. (
  • An independent safety officer (ISO) is a clinician or researcher who is independent of the clinical study team and helps to monitor a clinical trial for research participant (patient) safety, adverse events, trial progress, and data quality. (
  • For clinical trials with intermediate complexity or risk, the use of an ISO can be very helpful to monitor the trial for research participant safety, adherence to the protocol, and collection of good data. (
  • Examples of studies monitored by an ISO might include a trial involving Food and Drug Administration (FDA) approved drugs used in unapproved indications, non-significant risk medical devices, nutritional products used as a drug, research-only interventions such as an insulin clamp, or behavioral interventions with the possibility of psychological adverse events. (
  • This allows the ISO to assess the safety of the research participants throughout the course of the trial. (
  • He has been closely involved in the design, conduct, and analysis of cancer clinical trials and other research projects in cancer throughout his career. (
  • RESEARCH DESIGN AND METHODS In a double-blind, 52-week, international phase 3 trial, adults with T1D were randomized to placebo ( n = 258) or once-daily oral sotagliflozin 200 mg ( n = 261) or 400 mg ( n = 263) after 6 weeks of insulin optimization. (
  • Clinical trials are research studies that investigate potential new drugs, new ways of giving treatments or different types of treatments and compare them to the current standard treatments. (
  • Some research has shown that taking part in a trial improves long-term survival, even if you do not have the drug/procedure being tested. (
  • RCTs are mainly used in clinical studies, but are also employed in other sectors such as judicial, educational, social research. (
  • Ethics and dissemination Approved by North West Preston NHS Research Ethics Committee (15/NW/0347). (
  • The IRB's purpose is to protect the rights and welfare of human research subjects recruited to advance medical knowledge," says Aman Buzdar, M.D., professor in MD Anderson's Department of Breast Medical Oncology and ad interim vice president for clinical research. (
  • This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. (
  • Her research interests include clinical trials and translational research. (
  • Data Sharing and Embedded Research. (
  • Comparison of Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices. (
  • Trials without tribulations: Minimizing the burden of pragmatic research on healthcare systems. (
  • Clinical research studies only work when people volunteer and give their permission to participate. (
  • DSMBs are playing an increasingly important role in the process of ensuring the highest standards for research participants medical safety and data quality of clinical trials. (
  • NIH policy provides each IC with the flexibility to implement the requirement for data and safety monitoring as appropriate for its clinical research activities. (
  • and established procedures for monitoring of clinical research sites. (
  • Dr. Bressler's main research interests have been collaborative efforts in clinical trials of common retinal diseases, including age-related macular degeneration and diabetic retinopathy, having chaired several NIH-sponsored and industry-sponsored multicenter randomized clinical trials and authored almost 300 peer-reviewed publications. (
  • He is a past chair of the NIH-sponsored Diabetic Retinopathy Clinical Research Network, and was responsible for guidelines, policies, protocol development as well as implementation, and to facilitate Network operations in a way that maintains academic integrity and optimal clinical trial performance. (
  • The DMC is comprised of an independent group of medical, scientific and biostatistics experts and is responsible for reviewing and evaluating patient safety and efficacy data for the Company's Phase 3 REGAL clinical trial. (
  • Inna Perevoszkaya , Clinical Biostatistics, Merck & Co . (
  • The Principal Investigator must have appropriate expertise and capability in biostatistics, data management, data analysis, and project management, and must possess a doctoral degree in an appropriate field. (
  • This course teaches you clinical trial designs including randomized controlled trials, ROC curves, CI and tests for relative risk and odds ratio, and an introduction to survival analysis. (
  • A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. (
  • This would allow the company sponsoring the trial to get regulatory approval earlier and to allow the superior treatment to get to the patient population earlier. (
  • It is extremely unlikely that the trial, should it continue to its normal end, would have the statistical evidence needed to convince a regulatory agency to approve the treatment. (
  • Clinical trial monitoring is a critical area of concern - get it wrong and the consequences can land a sponsor in regulatory hot water. (
  • If a clinical trial has regulatory lapses, excessive adverse events linked to the trial intervention, or fails to recruit adequate numbers of participants, the ISO may recommend that the clinical trial protocol be modified or the trial terminated. (
  • This List presents a comprehensive source of references for statistical guidance documents and related articles that are relevant to regulatory affairs for those statisticians that work on clinical studies. (
  • EMA/CHMP/539146/2013: Investigation of subgroups in confirmatory clinical trials [16] (EMA) provides guidance for assessors in European regulatory agencies on assessment of subgroup analyses in confirmatory clinical trials. (
  • Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. (
  • Pfizer has notified clinical trial investigators involved in the trial and regulatory agencies of the DMC recommendations. (
  • and secure storage of regulatory and clinical documents. (
  • To examine fundamental characteristics of interventional clinical trials registered in the database. (
  • The number of registered interventional clinical trials increased from 28,881 (October 2004-September 2007) to 40,970 (October 2007-September 2010), and the number of missing data elements has generally declined. (
  • Topics include tests for independence, comparing proportions as well as chi-square, exact methods, and treatment of ordered data. (
  • This course will teach you how to use various cluster analysis methods to identify possible clusters in multivariate data. (
  • This course will introduce you to the essential techniques of text mining as the extension of data mining's standard predictive methods to unstructured text. (
  • This course will teach you the statistical display and analysis methods used in monitoring clinical trials for safety, as well as the biases and pitfalls inherent in safety review. (
  • Spatial methods are especially important in the developing world, where health data sources are limited. (
  • Statistical development in this area includes methods to incorporate complex sampling schemes, reconstruction of underlying surfaces, spatio-temporal kriging, and dimension reduction for multivariate spatial data. (
  • We assessed the prevalence of randomized clinical trials (RCTs) stopped early for harm in HIV/AIDS and determined the quality of reporting of methods to inform the decision to stop the trial. (
  • The reporting of methods to inform the decision to stop trials for harm in this population is deficient in a variety of ways, including lack of stopping guidelines. (
  • Although the MRC draws attention to some of the influential randomized trials that it has funded, it does not really celebrate the key role it played in the 1950s in developing and applying clinical trial methods (see Appendix ). (
  • Methods to improve the design of clinical trials took an important step forward with the adoption of alternate allocation schedules to create similar treatment comparison groups. (
  • 2 Current noninvasive methods to monitor these processes are significantly limited. (
  • Dissolution dynamic nuclear polarization enables the acquisition of 13 C MR data with a dramatic gain in sensitivity over conventional 13 C MR methods. (
  • Methods and analysis The RCT is a pragmatic, two-arm, parallel group trial designed to test the clinical and cost-effectiveness of JtD compared with usual care. (
  • METHODS/DESIGN: The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. (
  • Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. (
  • Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. (
  • Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. (
  • Methods and analysis A multicentre parallel two-group randomised controlled trial with 1:1 individual allocation to usual ERS alone (control) or usual ERS plus web-based behavioural support (intervention) with parallel economic and mixed methods process evaluations. (
  • This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial evaluating the efficacy and safety of SAM-760 30 mg once daily (QD) for 12 weeks in subjects with AD on a stable regimen of donepezil 5 to 10 mg QD. (
  • Aggarwal SP, Zinman L, Simpson E et al (2010) Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. (
  • and three-armed trials with the test product, an active comparator and placebo. (
  • This study used the Sequential Parallel Comparison Design (SPCD), which is geared toward reducing the impact of high placebo responses in clinical trials. (
  • In the PROLONG trial, OBE022 or matching placebo is administered daily for 7 days to pregnant women who are receiving an infusion of atosiban for 48 hours, the current standard of care therapy for preterm labor in the countries in which the PROLONG trial is being conducted. (
  • This trial is a multicenter, randomized, double-blind, placebo-controlled, single dose study initiated prehospital in the ambulance. (
  • Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. (
  • These trials are open to challenge for bias, and they do nothing to reduce the placebo effect. (
  • 2 randomized placebo-controlled trials (Women's Health Initiative hormone therapy trials [WHI-HT]: estrogen-alone trial and estrogen-plus-progestin [E + P] trial). (
  • conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d ( n = 8506), or placebo ( n = 8102) in the E + P trial. (
  • In January 2005, a phase III trial in GIST was unblinded early when a planned interim analysis showed significantly longer time to tumor progression with Sutent compared to placebo. (
  • Randomized controlled clinical trials are widely recognized as providing the highest level of evidence in evaluating benefits and risks of interventions for treatment and prevention of diseases. (
  • A group or subgroup of participants in a clinical trial who receives specific interventions, or no intervention, according to the study protocol. (
  • In the COVID-19 pandemic, these include the remarkable speed in which data regarding benefits and risks of interventions are accumulated. (
  • For earlier trials (phase I and II), a DSMB may be appropriate if the studies have multiple clinical sites, are blinded (masked), are First-in-Man, or employ particularly high-risk interventions or vulnerable populations. (
  • He has played major scientific and administrative roles in numerous multicenter clinical trials and has served in a consultative or advisory capacity on others. (
  • We bring scientific and clinical leadership in cardiovascular disease in combination with operational excellence to conduct Phase II-IV multicenter clinical trials. (
  • The most reliable information about treatment effects comes from randomized controlled trials (RCTs). (
  • Clinical RCTs involve allocating treatments to subjects at random . (
  • the efficacy of upadacitinib has been reported from the five randomised controlled trials (RCTs) which comprise the phase III SELECT clinical programme. (
  • CTTI recommends that DMC members be independent of the trial sponsor and be provided with adequate resources and flexibility to perform their role of assessing benefit-risk (e.g., performing ad hoc analyses as needed, having full access to accumulating unmasked study data). (
  • Clinical trials registries: is it viable for the inclusion of conduct, performance, analyses and cost of trials? (
  • Interventional trials were identified and analyses were focused on 3 clinical specialties-cardiovascular, mental health, and oncology-that together encompass the largest number of disability-adjusted life-years lost in the United States. (
  • Reports and interim analyses for trial teams, steering committees and data monitoring committees. (
  • Final data analyses and reporting of results. (
  • Analyses will compare the two arms of the trial on an intention to treat as allocated basis. (
  • These kinds of analyses are intended to provide an early warning if a clinical study should be stopped because an experimental drug is clearly ineffective. (
  • Effect of intermittent pneumatic compression on disability, living circumstances, quality of life, and hospital costs after stroke: secondary analyses from CLOTS 3, a randomised trial. (
  • The DMC is comprised of an independent group of medical and scientific experts and is responsible for reviewing and evaluating patient safety and efficacy data for safeguarding the interest of study participants. (
  • We are grateful for the contributions of the study participants and their families and encourage them to consider other Alzheimer's disease clinical trials. (
  • Clinical trials may test an unknown procedure or may continue for years, and there is justifiable concern about enrolling participants and exposing them to an unproven treatment without ongoing oversight of the preliminary results. (
  • Also, current and potential trial participants could be freed to take other treatments, rather than this experimental treatment which is unlikely to benefit them. (
  • MRD negative rate across clinical response groups will be assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR) or very good partial response (VGPR) according to the IMWG criteria during or after the study treatment. (
  • The aim was to identify models which might be useful to a major public funder of randomised controlled trials when estimating likely time requirements for recruiting trial participants. (
  • Failure to recruit sufficient numbers of participants, or extended delays in recruitment can have serious implications for the success or otherwise of the trial. (
  • In deciding how long they will require to accrue participants, trialists are often over optimistic - in 2007 Campbell found that less than one third of publically funded trials managed to recruit according to their original plan [ 1 ]. (
  • Participants must read and sign the "informed consent" document before inclusion in a trial. (
  • Risks to clinical trial participants are controlled and monitored. (
  • Most interventional trials registered between 2007 and 2010 were small, with 62% enrolling 100 or fewer participants. (
  • The charter typically sets out the aspects of the trial that will be reviewed, the frequency of data review and written reports, a plan for adverse event identification and reporting, a plan for monitoring of data quality and accuracy, and the criteria for decision-making regarding continuation, modification or termination of individual participants or the clinical trial. (
  • The timing of the meetings depends on the risk to the participants as well as the degree of oversight needed for a particular trial. (
  • The clinical study is ongoing (that is, participants are receiving an intervention or being examined), but potential participants are not currently being recruited or enrolled. (
  • Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. (
  • Results will be disseminated to ERS services, primary healthcare providers and trial participants. (
  • Multicenter, randomized, clinical trial of 271 participants. (
  • Specifically, the DSMB is charged with monitoring the safety of participants and the quality of the data, as well as the appropriate termination of studies either when significant benefits or risks have been uncovered or when it appears that the clinical trial cannot be concluded successfully. (
  • In June of 1998, NIH issued a policy stating that 'each Institute or Center (IC) in NIH should have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or conducted clinical trials. (
  • Adaptive Designs are the future for clinical trials. (
  • Adaptive Design techniques already have had notable successes in cutting the costs of clinical trials and times to market for drugs. (
  • SMi's 2nd Annual conference on Adaptive Designs in Clinical Drug Development will showcase presentations from leaders in this exciting and profitable area, and provide the perfect environment to network with fellow delegates with an interest in the field. (
  • Will all trials be adaptive? (
  • Response-adaptive trials, often Bayesian in approach, have long been suggested as statistically more efficient and ethically better-grounded alternatives to standard experimental designs, such as equal allocations to experimental and control therapies ( 8 - 13 ). (
  • It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes. (
  • On a financial note, as a result of the expected savings to be generated from terminating TRACON sponsored trials of TRC105, we anticipate our current cash runway will now extend into the third quarter of 2020. (
  • Clinical trials in paediatric haematology-oncology: are future successes threatened by the EU directive on the conduct of clinical trials? (
  • The article focuses on the clinical trials in pediatric hematology-oncology among children in Europe. (
  • In similar comparisons, randomization and blinding were less frequently reported in earlier-phase, oncology, and device trials. (
  • Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. (
  • This book provides a comprehensive summary of common controversial issues frequently encountered in oncology trials. (
  • Given these data, we will terminate further enrollment in company sponsored trials of TRC105 in oncology. (
  • TRC105, the oncology formulation of carotuximab, is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. (
  • In addition to her clinical activities, Dr. Peethambaram has led several early therapeutics and novel cancer treatment trials, as well as presented in several national oncology meetings and been published in leading peer reviewed cancer journals. (
  • A phase II trial already has yielded encouraging data, with updated results being presented at the 17th annual meeting of the Connective Tissue Oncology Society (CTOS), which took place last November in Prague, Czech Republic. (
  • These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives. (
  • Causal inference also allows asking many questions in randomized trials: Does a treatment effect vary over patient subgroups defined by variables measured after randomization (such as adherence, becoming infected with a pathogen, or having a biomarker response to treatment)? (
  • Although several investigators have shown that functional lung can be identified using advanced imaging techniques and/or demonstrated the feasibility and theoretical advantages of avoiding functional lung during radiotherapy, to our knowledge this premise has never been tested via a prospective randomized clinical trial. (
  • This enables safety data to be analysed appropriately and a summary report provided to the trial steering committee, principal investigators and the relevant ethics committees in a meaningful way. (
  • Differences in trial design, study population, region, or pharmacological profile may explain differences in outcome compared with other 5-HT 6 receptor antagonists. (
  • He has participated in Steering Committees in numerous outcome trials in myocardial infarction and heart failure. (
  • Despite the improved prognostic relevance of the 2016 WHO molecular-based classification of lower-grade gliomas, variability in clinical outcome persists within existing molecular subtypes. (
  • Trial protocol OPPTIMUM-- does progesterone prophylaxis for the prevention of preterm labour improve outcome? (
  • Catalyst's lead candidate, Firdapse™ for the treatment of LEMS, is currently undergoing testing in a global, multi-center, pivotal Phase 3 trial and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). (
  • Dr. Moshe Talpaz, commented, "I look forward to working together with the other esteemed members of the Data Monitoring Committee on SELLAS' important pivotal Phase 3 REGAL study. (
  • CEL-SCI Corporation (NYSE American: CVM) announced today that the Independent Data Monitoring Committee (IDMC) for the Company's pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data. (
  • A DMC is a group of individuals who review accumulating trial data by treatment group in order to monitor patient safety and efficacy, ensure the validity and integrity of the trial, and make a benefit-risk assessment. (
  • This is a transnational prospective randomized trial comparing definitive carbon ion therapy versus photon or combined photon and protontherapy as standard treatment for unresectable or macroscopically uncompleted resected radioresistant tumors. (
  • While clinical trials have answered many questions about patient treatment, even more remain. (
  • If a treatment is deemed safe, it moves on to Phase II trials. (
  • Phase II trials look for treatment efficacy. (
  • The do not require as much patient time as phase I and II trials, but the duration of treatment is longer. (
  • LLY ) and AstraZeneca are discontinuing the global Phase 3 clinical trials of lanabecestat, an oral beta secretase cleaving enzyme (BACE) inhibitor, for the treatment of Alzheimer's disease. (
  • A data monitoring committee (DMC) - sometimes called a data and safety monitoring board (DSMB) - is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing. (
  • Many randomized clinical trials are double blind - no one involved with the trial knows what treatment is to be given to each trial participant. (
  • We believe that individual AE reports to ethics committees serve no useful purpose, because in most cases the study group identity (drug exposure) is not known in studies with blinded treatment arms and their value is limited. (
  • A trial data safety and monitoring committee is in the unique position of being able to review safety information according to the blinded treatment arms of the study. (
  • The article discusses the feasibility of using the results of animal studies as a basis to determine the efficacy of a treatment strategy in clinical trials. (
  • These biomarker measurements have enormous potential to improve public health through disease prevention and early detection, and to improve the clinical treatment of disease. (
  • A Prospective, Randomized, Controlled Trial Comparing the Outpatient Treatment of Pediatric and Adult Partial-Thickness Burns with Suprathel or Mepilex Ag. (
  • The advent of fair treatment allocation schedules in clinical trials during the 19th and early 20th centuries. (
  • Forlenza OV, Diniz BS, Radanovic M et al (2011) Disease-modifying properties of long-term lithium treatment for amnestic mild cognitive impairment: randomised controlled trial. (
  • Clinical trials are designed to add to medical knowledge related to the treatment, diagnosis and prevention of diseases or conditions. (
  • Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. (
  • The effect of TTFields has demonstrated significant activity in in vitro mesothelioma pre-clinical models both as a single modality treatment and in combination with pemetrexed and cisplatin, chemotherapies that are commonly used to treat malignant pleural mesothelioma. (
  • These data include demographics, such as age and gender, and study-specific measures (for example, blood pressure, prior antidepressant treatment). (
  • Each clinical trial phase is designed to answer a specific set of questions about a new drug or treatment, which means there are strict guidelines about who can participate. (
  • The aim of a Phase I trial is to find a safe dose of the treatment and look at the possible side effects. (
  • As trials compare new treatments with standard treatments, you may be selected to receive either the new treatment or the standard treatment. (
  • They have strict criteria for joining them to make sure that the results can be relied upon by comparing like with like, and not all treatment centres are involved in trials. (
  • This change in primary endpoint from mortality at 28 days is driven by the general decrease in mortality with advances in treatment for Critical COVID-19 and by initial observations in the clinical trial. (
  • In addition to its work on RLF-100, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 for the treatment of suicidal bipolar depression and is currently in Phase 3 trials. (
  • Trials are used to establish average efficacy of a treatment as well as learn about its most frequently occurring side-effects . (
  • In an open trial, the researcher knows the full details of the treatment, and so does the patient. (
  • In a single-blind trial, the researcher knows the details of the treatment but the patient does not. (
  • An Argos Therapeutics therapy that uses the immune system to fight kidney cancer has hit a wall after an analysis of the latest clinical trial data found that the experimental treatment was unlikely to work. (
  • Pfizer is pursuing a broad development program for sunitinib malate and is studying its role in the potential treatment of various solid tumors including advanced breast cancer , advanced non-small cell lung cancer , advanced colorectal cancer , advanced hepatocellular carcinoma and advanced hormone-refractory prostate cancer in Phase 3 trials. (
  • Asterias expects to report additional efficacy and safety data for Cohort 2, as well as for the currently-enrolling Cohorts 3 and 4, later this year. (
  • Sutent is currently approved for both advanced renal cell carcinoma (RCC) and second-line gastrointestinal stromal tumor (GIST), based on efficacy and safety data from large, randomized Phase 3 clinical trials. (
  • Large, multi-site clinical trials are commonly overseen by a Data Monitoring Committee or Data and Safety Monitoring Board (DSMB) consisting of expert clinicians, biostatisticians, and ethicists or patient advocates. (
  • Monitoring by an ISO may also be appropriate for higher risk single-site studies of short duration, such as pilot studies, for which convening a full DSMB is not feasible. (
  • This document has been created to assist grantees in establishing and operating a Data and Safety Monitoring Board (DSMB) for clinical trials sponsored by the National Institute on Drug Abuse (NIDA). (
  • Monitoring by a DSMB is required by NIH for some trials or may be implemented by a grantee whenever he/she feels it is appropriate. (
  • A DSMB might be considered for practical reasons such as for trials with high chance of early termination for safety or efficacy reasons, or to have an independent review group that may help to add validity to the trial. (
  • Grant applications involving clinical trials that are required to have a DSMB must submit a general description of the DSMB plan as part of the Data and Safety Monitoring Plan (DSMP). (
  • A detailed DSMP including the operations of the DSMB must be submitted to and approved by NIDA before the trial begins. (
  • Phase IV trials are designed to help optimize already available treatments. (
  • Although randomized clinical trials are the gold standard for establishing the effectiveness of medical treatments, it is widely recognized that they raise nontrivial ethical issues. (
  • Clinical drug trials are divided into 4 phases to examine the safety of a new drug and compare it to existing treatments. (
  • As part of our mission to eliminate cancer, MD Anderson researchers conduct hundreds of clinical trials to test new treatments for both common and rare cancers. (
  • At the most recent IDMC meeting in October 2019 the IDMC reviewed "progression free and overall survival and limited demographic and safety data available for the aforementioned protocol. (
  • The IDMC reviewed the data from the first 30 subjects randomized in PROLONG and recommended to continue the trial without modifications. (
  • The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. (
  • In summary, this is an excellent book covering commonly encountered controversial issues for cancer clinical trials. (
  • Find out about ovarian cancer clinical trials - what they are, how they work and how you can find out more. (
  • Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study. (
  • That clinical trials are required to have independent data and safety monitoring boards ( 2 ) with the power to review partial data and recommend early termination of the trial is an indicator of inherent ethical discomfort. (
  • After a clinical trial is over, the ethical nuances and the unrecorded discussions of its safety monitoring boards are forgotten with time. (
  • The decision to stop trials early because of the harmful effects of the intervention is complex and requires weighing statistical, logistical, and ethical considerations. (
  • All human studies must state that they have been approved by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki. (
  • Clinical Trials--Are They Ethical? (
  • However, there is quite marked variation in how, to whom and indeed if such safety reporting is required in investigator-initiated clinical trials. (
  • Small, minimal risk studies may be monitored by the principal investigator according to the data and safety monitoring plan (DSM plan) approved by the institutional review board (IRB). (
  • They are not a part of the study team and have no financial or scientific conflicts of interest with the clinical trial or the principal investigator. (
  • In addition, the specific responsibilities of the ISO for that trial are defined by the ISO charter written by the principal investigator and the ISO. (
  • An ISO meets regularly with the principal investigator and study team to review the progress of the trial. (
  • September 28, 2016 - NIAID Policy: Investigator-Initiated Clinical Trials. (
  • She has been principal investigator in over 30 clinical trials and currently is the principal investigator of 8 clinical trials at UIC. (
  • There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials. (
  • Five studies reported a priori defined adverse events, and only 1 trial reported planned stopping guidelines. (
  • Two trials were stopped due to sudden unanticipated adverse events (Stevens-Johnson syndrome, death, and encephalopathy). (
  • Specifically, Phase I and II gene transfer trials must comply with additional requirements imposed by NIH Guidelines, e.g., reporting of adverse events to the Office of Science Policy. (
  • A Data Monitoring and Ethics Committee has been constituted. (
  • FREMONT, Calif. , April 25, 2017 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST) today announced that following a regularly scheduled interim review of safety data from its SCiStar Phase 1/2a clinical trial of AST-OPC1 for acute spinal cord injury, the study's Data Monitoring Committee (DMC) recommended continuation of enrollment for the 10 million cell and 20 million cell dose cohorts in the study, as planned. (
  • A Preliminary Study of Clinical Trial Enrollment Decisions Among People With Mild Cognitive Impairment and Their Study Partners. (
  • May 26- Can Increased Data Access Improve Patient Enrollment and Engagement? (
  • In addition, an ISO has experience with clinical trials so that they can monitor the progress of the trial for adequate enrollment, appropriate follow-up, adherence to protocol, and good data collection. (
  • Study record managers: refer to the Data Element Definitions if submitting registration or results information. (
  • citation needed] As an example, suppose a trial is one-half completed, but the experimental arm and the control arm have nearly identical results. (
  • It cites several reasons on why animal studies have failed to support the results in clinical trials, such as critical disparities and. (
  • Patient study explores trial results question. (
  • We compared our results for suicidality (our supplementary data C)5 with the RIAT paper (its Appendix 3)4 and confirmed that there was selective reporting within the CSR itself. (
  • [12] This document addresses the intrinsic characteristics of the drug recipient and extrinsic characteristics associated with environment and culture that could affect the results of clinical studies carried out in regions and describes the concept of the "bridging study" that a new region may request to determine whether data from another region are applicable to its population. (
  • Our review provides an overview of the results from the daratumumab clinical trials conducted to date, as well as practical management considerations for the use of daratumumab based on our experience with the agent. (
  • A significant advance will be the results of a randomized controlled trial looking at scheduled surveillance vs. at need, being conducted in the United Kingdom, and genetic studies will identify those with early treatable dysplastic change and those at risk of progression to esophageal adenocarcinoma. (
  • Therefore double-blind (or randomized) trials are preferred, as they tend to give the most accurate results. (
  • This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. (
  • Publication of this supplement was funded by the 2nd Clinical Trials Methodology Conference. (
  • During his many years there, Dr. Friedman was involved in numerous clinical trials and epidemiology studies, having major roles in their design, management and monitoring. (
  • Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. (
  • This course will teach you to design appropriate conjoint and choice studies using surveys, panels, designed experiments, be able to analyze and interpret the resulting data. (
  • Adverse event (AE) and serious AE (SAE) data are crucial information in drug and device development studies ( Box 1 ). (
  • The article reports on the clinical studies in Cell Stem Cell that eliminates the role of hedgehog signalling in the development of leukemia in adults. (
  • For example, observational studies face challenges of selection bias due to confounding, and causal inference studies the definition, identification, and estimation of the causal effect of an exposure on a disease endpoint, with interpretation as if the study were a randomized trial with no missing data. (
  • Six studies reported the presence of a data safety and monitoring board. (
  • The FDA has issued more than 100 guidance documents relating to clinical trials covering topics from the Animal Rule to validating software used in studies. (
  • Animal studies were approved by the Institutional Animal Care and Use Committee. (
  • Only studies discussing prediction of recruitment to trials using a modelling approach were included. (
  • Strengthened reporting requirements for studies registered with enable a comprehensive evaluation of the national trials portfolio. (
  • A data set comprising 96,346 clinical studies from was downloaded on September 27, 2010, and entered into a relational database to analyze aggregate data. (
  • In preclinical studies bringing these two technologies together, the rationale for the present clinical study was supported by the potent antiviral effects that were demonstrated in vitro , regardless of patient status or the tropism of the infecting virus ( 5 ). (
  • However, any such hopes were dashed last week after Biogen and its partner, Japanese drugmaker Eisai, halted two late-stage clinical studies evaluating aducanumab in treating Alzheimer's disease. (
  • Heinz Ludwig received fees for participation in data monitoring committees of early daratumumab studies. (
  • There are in vitro , animal studies and pre-clinical data suggesting that statins may be beneficial in ALI. (
  • Sign up for Insight Alerts highlighting editor-chosen studies with the greatest impact on clinical care. (
  • This happens after a license has been granted, and involves studies to monitor the medicine on an ongoing basis to see if there are any unexpected side effects, or if it causes problems in certain categories of people. (
  • Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. (
  • The NIAID has a robust infrastructure for conducting clinical studies that includes independently managed resources provided through grants, cooperative agreements, and contracts, as well as resources that are integrated within existing NIAID-supported clinical trial networks. (
  • Proposed clinical trials may use NIAID's independent infrastructure for clinical studies, however, support will not be provided for studies that propose to use dedicated resources that are part of a NIAID-supported clinical trial network. (
  • She has served on Data and Safety Monitoring Committees and on the Executive Committee of several studies. (
  • This initiative will establish a Statistical and Clinical Coordinating Center (SACCC) to support clinical studies in organ transplantation to be conducted by two NIAID-sponsored clinical consortia, the Clinical Trials in Organ Transplantation (CTOT) Consortium and the Cooperative Clinical Trials in Pediatric Transplantation (CCTPT) Consortium. (
  • The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), invites applications for the establishment of a Statistical and Clinical Coordinating Center (SACCC) to support clinical studies in organ transplantation to be conducted by two NIAID-sponsored clinical consortia, the Clinical Trials in Organ Transplantation (CTOT) Consortium and the Cooperative Clinical Trials in Pediatric Transplantation (CCTPT) Consortium. (
  • The DMC for the HEAT study is comprised of an independent group of medical and scientific experts with the responsibility for reviewing and evaluating patient safety and efficacy data from the Company's Phase III ThermoDox HEAT study. (
  • The Company's clinical-stage pipeline includes: DE-122, the ophthalmic formulation of carotuximab being developed in wet AMD through a collaboration with Santen Pharmaceutical Company Ltd. (
  • This event is aimed at all those involved in implementing clinical trials, or associated statistical work. (
  • However, the company opted to scuttle this second futility analysis to "preserve the statistical power" for the final analysis from the clinical trial. (
  • Verstraete E, Veldink JH, Huisman MH et al (2012) Lithium lacks effect on survival in amyotrophic lateral sclerosis: a phase IIb randomised sequential trial. (
  • It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. (
  • Subjects with suspected acute stroke will be identified in the field by trained paramedics using the approved stroke protocol in use by the local EMS system, and further screened for eligibility and approval by an on-call trial physician. (
  • Acute lung injury (ALI) is a common devastating clinical syndrome characterized by life-threatening respiratory failure requiring mechanical ventilation and multiple organ failure. (
  • Detection of minimal residual disease in childhood acute lymphoblastic leukemia: technology and clinical applications. (
  • The DMC's recommendation to continue our SCiStar study without modification reaffirms the committee's previous safety review of AST-OPC1 in August 2016 , and confirms initial safety data from the high dose cohorts (10 million and 20 million AST-OPC1 cells) in the study," said Dr. Edward Wirth , Chief Medical Officer of Asterias Biotherapeutics. (
  • A randomized controlled trial (RCT) is a scientific procedure most commonly used in testing medicines or medical procedures . (
  • These additional precautions are often in place with the more commonly accepted term "double blind trials", and thus the term "triple-blinded" is infrequently used. (
  • Eligible tumors are axial chordoma (except of base of skull), adenoid cystic carcinoma of head and neck (except of trachea) and sarcomas of any site (except chondrosarcoma of the skull base), non previously irradiated and without pre-planned surgery or chemotherapy after the clinical trial procedure. (
  • And for statisticians involved in the design of cancer trials, the diverse options of design and sample size calculations are well covered. (
  • CHMP/EWP/5872/03: Data monitoring committees [3] (EMA) deals with independent data monitoring committees. (
  • An independent data monitoring committee recommended to stop the trial for early success. (
  • Initially, Axsome planned for the study's Independent Data Monitoring Committee to perform another interim futility analysis. (
  • ObsEva SA Reports Positive Feedback from Independent Data Monitoring Committee for PROLONG Part B with OBE022. (
  • An Independent Data Monitoring Committee will perform safety reviews of the clinical data. (
  • ARGS ) Phase 3 clinical trial, the independent data monitoring committee recommended stopping the study for futility, the company announced this morning. (
  • This is the second phase III Sutent trial Pfizer has stopped early on the recommendation of an independent data monitoring committee due to benefit. (
  • Independent Data Monitoring Committee C Baigent (Oxford), J Bamford (Leeds, Chair), J Slattery (London). (
  • Most Common FDA findings from clinical site inspections. (
  • How to use trended data from audits and common FDA findings to ensure audit program will identify these issues. (
  • We report findings from a clinical evaluation of lentiviral vectors in a phase I open-label nonrandomized clinical trial for HIV. (
  • An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study is over. (
  • In 2013, it was assessed that the CLOTS1 and 2 trial findings had resulted in approximately 6000 fewer complications (e.g., skin breaks) in the UK. (
  • Clinical trials often require more intensive monitoring, which may equate to more frequent appointments, viral genotyping or phenotyping, and monitoring of patient characteristics (such as blood levels of certain chemicals). (