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
DUBLIN, Oct. 31, 2016 /PRNewswire/ -- Theravance Biopharma Presents Interim Data from Ongoing Telavancin Observational Use Registry (TOUR™) at IDWeek™...
HANGZHOU and SHAOXING, China, June 21, 2016 /PRNewswire/ -- Ascletis Publishes Interim Data of Phase II Study in Taiwan for its Interferon-free HCV...
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 ...
Reviews of Data Monitoring Committees in Clinical Trials: A Practical Perspective: Levin, Bruce (January-February 2003), "No, ... With Thomas Fleming and David DeMets, Ellenberg is the author of Data Monitoring Committees in Clinical Trials: A Practical ... 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 and Safety 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, ...
"Coronado Biosciences Announces Independent Data Monitoring Committee Recommendation to Discontinue Falk Phase 2 Trial of TSO in ... Early clinical trials suggested that exposure to helminths such as Trichuris suis or Necator americanus can improve IBD. ... Early trials of Trichuris suis ova (TSO) showed promising results when used in people with IBD but later trials failed at Phase ... However, the phase 2 trials had used a different formulation of TSO from the one that had been used in the earlier studies that ...
... 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 ...
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 ...
Independent Data Monitoring Committee Halts Study Early for Overwhelming Efficacy". Veru Inc. (Press release). 11 April 2022. ... "Veru Enrolls First Patient in Phase 3 Clinical Trial of Sabizabulin (VERU-111) in High Risk Hospitalized COVID-19 Patients". ... "Veru Announces Oral Late-Breaking Presentation of Phase 2 Data of Sabizabulin for the Treatment of Hospitalized Severe COVID-19 ... (Press release). 13 April 2021. Retrieved 1 May 2022. Li, Chien-Ming; Lu, Yan; Chen, Jianjun; Costello, ...
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 ... "Otic Pharma to Become Majority Owner of Tokai Pharma (TKAI)". "Lowe inks new deal for clinical trials of another cancer drug". ... 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 ...
"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 ... "Home Affairs Committee - Drugs: Breaking the CycleWritten evidence submitted by Sheila M Bird OBE MA PhD CStat FFPH, Medical ... Parmar MK, Strang J, Choo L, Meade AM, Bird SM (2016). "Randomized controlled pilot trial of naloxone-on-release to prevent ...
... 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 ... Psychiatric diseases Randomized clinical control trials have shown promising results of EPO in improving cognition which is ... In a randomized controlled trial, erythropoietin was shown to not change the number of blood transfusions required by ...
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. Her ... and was developed through fruitful contacts with clinical and epidemiological research. ...
Philippines Data monitoring committee for a clinical trial Detailed marks certificate, a detailed report of academic ... a category within the DLNA standard Data Matrix Code, laser etched square code, often used for marking products in the ... performance Digital Media City, Seoul, South Korea Disaster Monitoring Constellation of imaging satellites DMC International ...
Clinical trial Complication (medicine) Good clinical practice (GCP) Data monitoring committees Serious adverse event Adverse ... influences the extent and nature of data. A 2018 review conducted found that some participants in clinical drug trials were ... "Eliciting adverse effects data from participants in clinical trials". The Cochrane Database of Systematic Reviews. 1: MR000039 ... Clinical trial results often report the number of grade 3 and grade 4 adverse events. Grades are defined: Grade 1 Mild AE Grade ...
... 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 ...
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 ...
... 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 stockholders" letter in January, 2007, that highlighted results from a recent anemia of cancer trial, and ...
"Coronado Biosciences Announces Independent Data Monitoring Committee Recommendation to Discontinue Falk Phase 2 Trial of TSO in ... Early clinical trials suggested that exposure to helminths such as Trichuris suis or Necator americanus can improve IBD. ... "Evidence Check 2: Homeopathy - Science and Technology Committee". British House of Commons Science and Technology Committee. ... Vermeire S (June 2004). "NOD2/CARD15: relevance in clinical practice". Best Practice & Research. Clinical Gastroenterology ( ...
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) Amendment (No.2) Regulations 2006 (Good clinical practice, Clinical research, Pharmaceutical industry, Good ...
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 ...
... data monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the ... Data and Safety Monitoring Board or Independent Data Monitoring Committee DSMB. An impartial group that oversees a clinical ... The terms clinical trial and clinical study are synonymous. (ICH E6) Clinical Trial/Study Report A written description of a ... Also called a clinical trial. (NCI) A clinical trial is a research study to answer specific questions about vaccines or new ...
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 ...
... 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 ...
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 ...
... 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 ( ...
... 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 ...
"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 concept of a controlled clinical trial was first described in 1662 by Jan Baptist van Helmont in reference to the practice ... 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.[65] ... or reports of expert committees. ... Analysis of clinical trials. *Risk-benefit ratio. *Systematic ...
Meta-analysis of individual patient data in randomised trials of self monitoring of blood glucose in people with non-insulin ... American College of Obstetricians and Gynecologists Committee on Practice Bulletins-. ACOG Practice Bulletin. Clinical ... 29,0 29,1 29,2 International Expert Committee (July 2009)։ «International Expert Committee report on the role of the A1C assay ... Mary Lee (2013)։ Basic Skills in Interpreting Laboratory Data։ ASHP։ էջեր Chapter 13։ ISBN 9781585283453 ...
... randomised clinical trial". British Medical Journal. 325 (362): 362. doi:10.1136/bmj.325.7360.362. PMC 117885. PMID 12183307. ... Twentieth report of the WHO Expert Committee 2015 (including 19th WHO Model List of Essential Medicines and 5th WHO Model List ... "FDA issues proposed rule to address data gaps for certain active ingredients in health care antiseptics". U.S. Food and Drug ... Sanchez-Prado, Lucia; Llompart, Maria; Lores, Marta; García-Jares, Carmen; Bayona, Josep M.; Cela, Rafael (2006). "Monitoring ...
A Bayesian Network Meta-analysis of Randomized Clinical Trials". American Journal of Kidney Diseases (Systematic Review & Meta- ... "United States Renal Data System (USRDS)". Diarsipkan dari versi asli tanggal 2007-02-13.. Parameter ,url-status=. yang tidak ... Qaseem A, Hopkins RH, Sweet DE, Starkey M, Shekelle P (December 2013). "Screening, monitoring, and treatment of stage 1 to 3 ... report from the panel members appointed to the Eighth Joint National Committee (JNC 8)". JAMA. 311 (5): 507-20. doi:10.1002/ ...
... data collection, or administration) or, Patient management prior to or following administration (monitoring, disease or ... "introduce important medicines to the market based on very promising phase 2 rather than phase 3 clinical trial results". ... a b c Committee on Rheumatologic Care, (2015). The Complexity of Biologics and their Coverage and Payment. American College of ... monitor patients for adverse events and work with primary care provider offices to monitor the outcomes of the medication.[69] ...
"A Low-Fat Vegan Diet Improves Glycemic Control and Cardiovascular Risk Factors in a Randomized Clinical Trial in Individuals ... jūnijā, Wayback Machine vietnē., Physicians Committee for Responsible Medicine. *↑ "A new food guide for North American ... "Is Tel Aviv's vegan craze here to stay?, Al-Monitor, 6 March 2014.Veidne:Pb Tova Cohen, "In the land of milk and honey, ... "American Journal of Clinical Nutrition 78 (3): 533S-538S. PMID 12936946. Atjaunināts: 2008-01-31. "Secinājums - gan britu ...
Variants: distribution of cases data» (en anglès), 18-02-2021. *↑ Risk related to the spread of new SARS-CoV-2 variants of ... Moderna Launches Trial For Covid-19 Vaccine Booster To Tackle South African Strain» (en anglès). Forbes Breaking News, 25-01- ... Neutralization of variant under investigation B.1.617 with sera of BBV152 vaccinees». Clinical Infectious Diseases. Oxford ... Following a risk assessment with the relevant expert committee, they may be designated Variant of Concern (VOC)» ...
Funds Dissemination Committee (FDC). The Funds Dissemination Committee (FDC) makes recommendations about how to allocate ... infoboxes (making it possible to store the data that is currently in infoboxes in one central place and share the data) ... We will be monitoring the usage to check for any failures or issues, but please do let us know on the Content Translation talk ... DynaMed - clinical reference tool for medical topics. *Royal Pharmaceutical Society - pharmaceutical information and practice ...
A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19) ... Kinesiske data har vist andelene på henholdsvis 80.9%, 13.8% og 4.7%. For de kritisk tilfælde er dødeligheden fundet til 49%.[ ... The virus itself has been designated SARS-CoV-2 by the International Committee on Taxonomy of Viruses..." ... risk with acute life-threatening events that require adequate treatment with anticoagulants based on laboratory monitoring with ...
... an instrumental variables re-analysis of randomized clinical trials". Alcoholism: Clinical and Experimental Research. 38 (11): ... voted to dissolve its Institutions Committee and form two separate committees, one for treatment facilities, and one for ... "Historical Data: The Birth of A.A. and Its Growth in the U.S./Canada",, retrieved 18 April 2019 ... but recent high quality clinical meta-studies using randomized trials show that AA costs less than other treatments and results ...
While these are made available to those who wish to license this data, Elsevier cannot make such a large corpus of data, to ... "American Committee on Asian Economic Studies. Retrieved 20 August 2020.. *^ Wiemer, Calla. "The state of journal publishing: ... J. Cardiol.), the Australasian Journal of Clinical Pharmacy (Australas. J. Clin. Pharm.), and the Australasian Journal of ... "Hated Science Publisher Elsevier To Help EU Monitor Open Science - Including Open Access". Techdirt. Retrieved 5 April 2018.. ...
Clinical trials[edit]. Bedaquiline has been studied in phase IIb studies for the treatment of multidrug-resistant tuberculosis ... Twentieth report of the WHO Expert Committee 2015 (including 19th WHO Model List of Essential Medicines and 5th WHO Model List ... Collaborative Group for the Meta-Analysis of Individual Patient Data in MDR-TB treatment-2017) (September 2018). "Treatment ... Centers for Disease Control Prevention (October 2013). "Provisional CDC guidelines for the use and safety monitoring of ...
It can be monitored to ensure that a page, or a set of pages, keeps its quality. A person willing to maintain pages will be ... Au, C. H. (December 2017). "Wiki as a research support system - A trial in information systems research". 2017 IEEE ... and committee work.[41] In the mid-2000s, the increasing trend among industries toward collaboration placed a heavier impetus ... a data systems specialist, summarizes the controversy as follows: "Most people when they first learn about the wiki concept, ...
Committee on Temporomandibular Disorders (TMDs): From Research Discoveries to Clinical Treatment; Board on Health Sciences ... Ear canal inserts are also available, but no published peer-reviewed clinical trials have shown them to be useful. ... "Medical Science Monitor. 24: 812-817. doi:10.12659/MSM.908810. PMC 5813878. PMID 29420457.. ... Data concluded from a systematic review showed that only extensive erosions and large osteophytes can be detected by panoramic ...
Monitoring in clinical trials. *Ethics committee. *Institutional review board. *Data monitoring committee ... Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical ... Main article: Phases of clinical research. Clinical trials involving new drugs are commonly classified into four phases.[6] ... "Clinical science" redirects here. For the journal, see Clinical Science (journal).. Clinical research is a branch of healthcare ...
National Institute Clinical Excellence (August 2011). "1.5 Initiating and monitoring antihypertensive drug treatment, including ... Data from the health examination surveys, 1960 to 1991". Hypertension. 26 (1): 60-9. doi:10.1161/01.HYP.26.1.60. PMID 7607734. ... A scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood ... februar 2006). "Lifestyle interventions to reduce raised blood pressure: a systematic review of randomized controlled trials". ...
How to conduct European clinical trials from the Paris Region ? Clinical Trials. Paris. February 2003 ... Christian Science Monitor (12 July 2012)Retrieved on 25 April 2013 *↑ France. Berkley Center for Religion, Peace, and World ... Although it is illegal for the French state to collect data on ethnicity and ancestry, a law with its origins in the 1789 ... Paris was the first home of the International Olympic Committee, before it moved to Lausanne.[៣៧១] Since 1900, France has ...
"No clinical benefit from use of hydroxychloroquine in hospitalised patients with COVID-19". Recovery Trial, Nuffield Department ... Also opposed to the bill was the conservative National Physicians Committee. The committee began a membership drive in February ... A Critical Review of Recent Studies Based on Prospective Data" (PDF). Journal of American Physicians and Surgeons. 10 (4): 105- ... They went to court to block enforcement of a Social Security amendment that would monitor the treatment given to Medicare and ...
Reviews on Recent Clinical Trials. 2 (1): 3-19. CiteSeerX doi:10.2174/157488707779318107. PMID 18473983. ... these patients show a very robust clinical response consistent with that observed in pediatric studies. These data suggest that ... "Monitor on Psychology. 34 (2): 28. Archived from the original on 9 April 2017.. ... "Background Document for the Food Advisory Committee: Certified Color Additives in Food and Possible Association with Attention ...
American Society of Clinical Oncology Resource-Stratified Clinical Practice Guideline". Journal of Global Oncology. 2 (5): 311- ... August 2018). "Evidence for single-dose protection by the bivalent HPV vaccine-Review of the Costa Rica HPV vaccine trial and ... Committee on Practice Bulletins-Gynecology (November 2012). "ACOG Practice Bulletin Number 131: Screening for cervical cancer ... Interventions such as playing music during the procedure and viewing the procedure on a monitor can reduce the anxiety ...
In doing so, the committee concluded, through blind trials that mesmerism only seemed to work when the subjects expected it, ... The Christian Science Monitor. Retrieved August 21, 2018. Charles Osborne (April 1, 1994). The bel canto operas of Rossini, ... International Journal of Clinical and Experimental Hypnosis. 50 (4): 332-363. doi:10.1080/00207140208410109. PMID 12362951. ... News from Wikinews Quotations from Wikiquote Texts from Wikisource Textbooks from Wikibooks Resources from Wikiversity Data ...
... on Immunizationand is a member of the National Health Data Advisory and Coordination Committee chairing the TB/HIV committee. ... She was the Protocol Chair of the first SA microbicide network trial (FACTS 001), a Phase 3 trial of 1% tenofovir gel for HIV ... She is a member of the SAGE Working Group on Measles and Rubella, and of the SAGE Working Group monitoring the progress of the ... Rees is an Honorary Professor in the Department of Clinical Research at the London School of Hygiene and Tropical Medicine. ...
For external monitoring of the fetus during childbirth, a simple pinard stethoscope or doppler fetal monitor ("doptone") can be ... American Academy of Pediatrics Committee on Fetus Newborn; American College of Obstetricians Gynecologists Committee on ... Unless there is some other indication, mothers can attempt a trial of labour and most are able to have a vaginal birth after C ... Obstetric Data Definitions Issues and Rationale for Change Archived 6 November 2013 at the Wayback Machine, 2012 by ACOG. Boyle ...
PsycLAW: Romer v. Evans Kersting, Karen (May 2003), "APA submits a record four Supreme Court amicus briefs", APA Monitor, p. 58 ... He testified in Perry v. Schwarzenegger trial. Herek has also conducted research documenting the prevalence of stigma directed ... From 1995 to 2007, he served as chairperson of the Scientific Review Committee of the American Psychological Foundation's Wayne ... Journal of Consulting and Clinical Psychology, vol. 67, no. 6, pp. 945-951, doi:10.1037/0022-006x.67.6.945, PMID 10596515, ...
A second man pleads not guilty and iis committed for trial on 23 November. The latest NHS hospital data for England indicates ... a joint report published by the House of Commons Health and Social Care Committee and the Science and Technology Committee, as ... The clinical guidelines regarding the booster vaccine are to be changed for some people, such as care home workers, to allow ... "Covid: Pulse oxygen monitors work less well on darker skin, experts say". BBC News. 31 July 2021. Retrieved 4 August 2021. "UK ...
While these are made available to those who wish to license this data, Elsevier cannot make such a large corpus of data, to ... The suit came to trial in November 2011 and was dismissed in July 2012, with the judge ruling that the article was " ... As a consequence, all but one of the journal's editorial advisory committee members co-signed a letter of resignation. In ... J. Cardiol.), the Australasian Journal of Clinical Pharmacy (Australas. J. Clin. Pharm.), and the Australasian Journal of ...
The incidence of side effects with doxepin and its safety at these doses was similar to that of placebo in clinical trials; the ... Elks J (14 November 2014). The Dictionary of Drugs: Chemical Data: Chemical Data, Structures and Bibliographies. Springer. pp. ... ECG monitoring is recommended for several days after doxepin overdose due to the potential for cardiac conduction abnormalities ... Joint Formulary Committee (2013). British National Formulary (BNF) (65 ed.). London, UK: Pharmaceutical Press. ISBN 978-0-85711 ...
PARP inhibitor olaparib is an approved breast/ovarian cancer drug that is undergoing clinical trials. Also in trials for CRPC ... "Prostate Imaging-Reporting and Data System Steering Committee: PI-RADS v2 Status Update and Future Directions". European ... Active surveillance involves monitoring the tumor for growth or symptoms, which trigger treatment. The monitoring process may ... American Society of Clinical Oncology Provisional Clinical Opinion". Journal of Clinical Oncology. 30 (24): 3020-3025. doi: ...
Arteriovenous oxygen differences were calculated from the measured oxygen consumption and cardiac output data. The data ... In a 90-day bed rest trial, a 26% ± 7 decline in the CSA of the calf muscle was observed. This rate of decline is consistent ... Medical requirements for the Mercury astronauts were formulated by the NASA Life Sciences Committee, an advisory group of ... Highly refined exercise protocols and robust exercise equipment and methods to monitor functional capacity are mandatory for ...
Has Data Monitoring Committee No U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes. ... NCI-2014-02621 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ). I 247913 ( Other Identifier: Roswell Park ... 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 ...
What Participants Need to Know About Clinical Trials - Explore from the Merck Manuals - Medical Consumer Version. ... Data safety and monitoring boards and committees In many large clinical trials, a group of experts who are not involved in the ... Leaving a clinical trial Clinical trial participants can always quit a trial if it proves to be uncomfortable or too ... The Clinical Trial Participants Bill of Rights. Any participant who gives consent to participate in a clinical trial or who is ...
Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and ... Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and ... Data Monitoring Committees in Clinical Trials: A Practical Perspective (Statistics in Practice) By: Susan S. Ellenberg (Author ... Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing ...
All-cause mortality was not affected during the trial. The risk-benefit profile found in this trial is not consistent with the ... Clinical Trials Data Monitoring Committees * Colorectal Neoplasms / epidemiology * Coronary Disease / epidemiology* * Coronary ... the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test ... This report includes data on the major clinical outcomes through April 30, 2002. Estimated hazard ratios (HRs) (nominal 95% ...
What Participants Need to Know About Clinical Trials - Explore from the MSD Manuals - Medical Consumer Version. ... Data safety and monitoring boards and committees In many large clinical trials, a group of experts who are not involved in the ... Leaving a clinical trial Clinical trial participants can always quit a trial if it proves to be uncomfortable or too ... The Clinical Trial Participants Bill of Rights. Any participant who gives consent to participate in a clinical trial or who is ...
Has Data Monitoring Committee No U.S. FDA-regulated Product Not Provided ... Riche DM, McEwen CL, Riche KD, Sherman JJ, Wofford MR, Deschamp D, Griswold M. Analysis of safety from a human clinical trial ... 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 ...
Join this webinar to learn more about incorporating microsampling into a clinical trial and evaluating the performance of ... Data Monitoring Committees in the Changing Landscape of Clinical Trials. April 29, 2021 Decentralized Clinical Trials: Lets ... The Promise of Microsampling in Supporting Remote Clinical Trials. Life Sciences, Clinical Trials, Pharmaceutical, Laboratory ... How Digital Therapeutics and Remote Patient Monitoring Can Drive Pharmaceutical Product Differentiation. ...
Clinical trial for NonHodgkin Lymphoma , Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma. ... Independent data monitoring committee (IDMC). The Tata Memorial Hospital Ethics Committee has established the Data and Safety ... Monitor the overall progress of institutional clinical trials and for ensuring adherence to clinical trial and procedural ... Monitoring Sub Committee for monitoring the conduct of the institutional trials. The Committee has 15 members and meets on the ...
Trial has a data monitoring committee. No E.8.8. Definition of the end of the trial and justification where it is not the last ... The EU Clinical Trials Register currently displays 43207 clinical trials with a EudraCT protocol, of which 7151 are clinical ... Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be ... Clinical trials The European Union Clinical Trials Register allows you to search for protocol and results information on: * ...
Independent academic Data Monitoring Committees for clinical trials in cardiovascular and cardiometabolic diseases. Filippatos ... Individual participant data analysis of two trials on aldosterone blockade in myocardial infarction. Beygui, F., van Belle, E. ... Influence of systolic blood pressure on clinical outcomes in elderly heart failure patients treated with nebivolol: data from ... a meta-analysis with 5-year patient-level data from the ARTS, ERACI-II, MASS-II, and SoS trials. Daemen, J., Boersma, E., ...
Trial has a data monitoring committee. Yes E.8.8. Definition of the end of the trial and justification where it is not the last ... The EU Clinical Trials Register currently displays 42869 clinical trials with a EudraCT protocol, of which 7063 are clinical ... Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be ... Clinical trials The European Union Clinical Trials Register allows you to search for protocol and results information on: * ...
Clinical Trials Data Monitoring Committees 100% * Practice Guidelines 60% * Committee Membership 21% ... Data monitoring committees: Promoting best practices to address emerging challenges. Fleming, T. R., Demets, D. L., Roe, M. T. ... Zhang, J., Carlin, B. P., Neaton, J. D., Soon, G. G., Nie, L., Kane, R., Virnig, B. A. & Chu, H., Apr 2014, In: Clinical Trials ... Lan, G., Lindborg, S. & Neaton, J., Dec 2012, In: Clinical Trials. 9, 6, p. 736-740 5 p.. Research output: Contribution to ...
When the independent data monitoring committee and the regulatory authorities agreed to continuation of the study (clinical ... Clinical Programming Lead]); Clinical Working Group members (Sanne de Ridder [Clinical Trial Manager], Len Roza [ID&V Risk ... An independent data monitoring committee was established to assess the safety data regularly during the study. The study was ... EUCLID/F-CRIN Clinical Trials Platform (Christine Schwimmer, PhD [EUCLID Executive Director], Christine Betard [Clinical Trial ...
During a cluster-randomized clinical trial for trachoma in Ethiopia, two rounds of adverse event surveillance were performed in ... We thank the project officer for the clinical trial (Donald Everett, National Eye Institute, Bethesda, MD); the data safety and ... monitoring committee including William Barlow (University of Washington, Washington, DC; Chair), Donald Everett (National Eye ... On estimating efficacy from clinical trials. Stat Med 10: 45-52.. Sommer. A. Zeger. SL. , 1991. . On estimating efficacy from ...
... following a report by Economic Times which revealed that a serious adverse event was seen in a case during the Phase I trial of ... Bharat Biotech said that all adverse events were reported to the site ethics committee, CDSCO, data monitoring board and the ... Bharat Biotech said on Saturday that it had reported the adverse event that happened during the Phase I clinical trials to the ... 72hrs" data-no-of-words="315.0">. Reported adverse event during Covaxin phase 1 trial within 24 hours: Bharat Biotech. ...
Clinical Protocols, Clinical Trials Data Monitoring Committees, Research Groups, Neoplasmas Cerebrales, Neoplasmas de la Médula ... Clinical Protocols, Research Design, Child, Adolescent, Clinical Trials Data Monitoring Committees, Research Groups, Pediatrics ... ACRIN both funds and provides a complete infrastructure for multi-institutional clinical trials of imaging and related ... Clinical Protocols, Cancer Care Facilities, Neoplasmas Cerebelosos, Estadificación de Neoplasmas, recurrencia local del ...
Present/past member/chair of Independent Data Monitoring Committees of international clinical trials. November 2014 3 ... Luca Gianni has conducted clinical trials according to ICH / GCP. Last training on Sept 24th, 2013 (Clinical Trial SIV) ... 2010: Member of the evaluation committee (President) for the designation of early Phase clinical trials centers of the INCa of ... research clinical study cancer breast scientific gianni medical oncology tumori nazionale member istituto milan committee ...
... this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee ... "In the pivotal phase 3 clinical trial, ... said the Pfizer/BioNTech trial data indicated that there were ... Pfizers trial protocol shows that people with a history of severe allergic reaction (e.g., anaphylaxis) "to any component of ... The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination." ...
He is a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial. ... It also treats-in our view wrongly-clinical data as "confidential business information" (CBI), thereby confirming secrecy as ... which has carried out a number of clinical trials sponsored by vaccine manufacturers. MH has not been involved, in any way, ... Open data Post navigation. Ashish K Jha and Liana Woskie: Funding, trust, and the 69th World Health Assembly ...
Health Safety of Blood Tissues and Organs Advisory Committee and of the Data Monitoring Committee of the NHSBT Clinical Trials ... A progressive approach to organ utilisation, based on extensive clinical experience.. *Close collaboration between surgeons, ... Principal Statistician within the Statistics and Clinical Studies team at NHS Blood and Transplant (NHSBT) ...
Teva has discontinued development of the 1.2-mg and 1.5-mg doses because of eight cardiovascular events in two clinical trials ... The change comes at the recommendation of the data monitoring committee (DMC) overseeing two active clinical studies in MS. The ... Clinical trials such as these are made both scientifically and ethically better through the dedicated efforts of these ... "The main message from this story is how important the data monitoring committee is in the determination of public safety. ...
... changing the way that clinical trials are conducted. Find out more >> ... several clinical trial data monitoring committees and has been the principal statistician for over 50 completed clinical trials ... changing the way that clinical trials are conducted. Where-as placebo-controlled randomized trials control trials remain the ... Innovative Trial Design. Cytel is the largest provider of statistical software and advanced analytics for clinical trial design ...
13/06/2013 A systematic review of the reporting of Data Monitoring Committees roles, interim analysis and early termination in ... pediatric clinical trials Blog archives. Select Month. October 2020. September 2020. January 2019. September 2018. April 2018. ...
... in dose-ascending phase of study following recommendation by Independent Data Monitoring Committee... ... Dosed first patient in final cohort, Cohort 4, in dose-ascending phase of Imagine-1 clinical trial for GM1 gangliosidosis; ... Advanced Imagine-1 clinical trial for GM1 gangliosidosis to recruitment of final cohort, Cohort 4, ... Passage Bio Doses First Patient in Global Clinical Trial of PBFT02 Gene Therapy for Frontotemporal Dementia with Granulin ...
... the Data Monitoring Committee and the Trial Steering Committee. In this model, the Trial Steering Committee is the executive ... keywords = "trials, oversight committee, clinical trials unit, trial steering committee, clinical trial, randomised controlled ... the Data Monitoring Committee and the Trial Steering Committee. In this model, the Trial Steering Committee is the executive ... the Data Monitoring Committee and the Trial Steering Committee. In this model, the Trial Steering Committee is the executive ...
... is likely to be the first to have any efficacy data. ... by an independent committee called a data and safety monitoring ... If the vaccine is shown to be effective in the interim analysis of a well run clinical trial it should IMMEDIATELY be granted ... A warning, then, from past attempts from investors to read the tea leaves on clinical trials: They are frequently wrong. ... Making educated guesses about what is happening in a clinical trial is normal practice for investors who follow pharmaceutical ...
Alongside designing and recruiting to clinical trials, Dr Field chairs the Independent Data Monitoring Committee for an ongoing ... Dr Michael is a Medical Director for Surrey Clinical Trials Unit and a Cancer Lead for Kent Surrey And Sussex Clinical Research ... She led as PI/CI over 60 clinical trials - including global multi-national trials - in various therapeutic areas both early and ... He is also a member of the steering committees for Association of British Clinical Diabetologists national audits on COVID-19 ...
He serves on several Data Safety Monitoring Boards and protocol review committees.. ... Holubkov also regularly teaches courses on the design and analysis of randomized clinical trials and mentors clinical ... Co-Director of the Study Design and Biostatistics Center in the Center for Clinical Sciences (CCTS), and the chief ... and he also directed the Coordinating Center for an industry-sponsored international randomized trial comparing two mechanical ...
Overview The NISS Academic Affiliate Committee is holding a virtual meet-up on November 30, from 1:30-3pm ET, on How to ... Her book on clinical trials data monitoring committees, co-authored with Drs. Thomas Fleming (University of Washington) and ... Particular areas of interest include efficient trial designs, interim monitoring and the operation of data monitoring ... and special issues in trials of cancer and AIDS therapies, and of vaccines. She is an associate editor of Clinical Trials and ...
  • I. To collect preliminary data on therapeutic efficacy of this combination against multiple myeloma, including response rate, time to progression and disease progression slope. (
  • The authoritative guide for Data Monitoring Committees--fully revised and updated The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. (
  • Commenting for Medscape Medical News , Jeffrey Cohen, MD, Cleveland Clinic, Ohio, who is not involved in trials of the drug, said, "The higher dose of laquinimod was being evaluated to assess for better efficacy compared to 0.6 mg. (
  • Pfizer and BioNTech are under a white-hot spotlight because their Covid-19 vaccine, by design, is likely to be the first to have any efficacy data. (
  • At an advisory panel of outside experts the FDA held last week, the agency signaled that it was not certain it would grant an EUA for a vaccine until a sufficient amount of data had been accumulated to more fully understand the safety and efficacy of a vaccine prospect. (
  • Committees established to review interim data and efficacy outcomes in clinical trials. (
  • We examined the association between baseline UACR and the effects of the SGLT2 inhibitor, canagliflozin, on efficacy and safety outcomes in the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) randomized controlled trial. (
  • Identify clinical implications of safety and efficacy of Omr-IgG-am compared with that of IVIG and NS in patients with WNV neuroinvasive disease in a phase 2, randomized, double-blind, multicenter study. (
  • Preoperative use of the somatostatin analogue pasireotide has been studied but its efficacy in reducing clinical relevant POPFs remains questionable, and its expense and adverse effects limit its usefulness. (
  • From October 2013 to February 2015, the ACIP HPV Vaccine Work Group reviewed clinical trial data assessing the efficacy, immunogenicity, and safety of 9vHPV, modeling data on cost-effectiveness of 9vHPV, and data on burden of type-specific HPV-associated disease in the United States. (
  • In a phase III efficacy trial comparing 9vHPV with 4vHPV among approximately 14,000 females aged 16 through 26 years, 9vHPV efficacy for prevention of ≥CIN2, vulvar intraepithelial neoplasia grade 2 or 3, and vaginal intraepithelial neoplasia grade 2 or 3 caused by HPV 31, 33, 45, 52, or 58 was 96.7% in the per protocol population* ( Table 2 ) ( 2 , 16 ). (
  • This review aims to summarise the current data for COVID-19 vaccine efficacy in patients with cancer, suggest priority areas for future research and look at potential disparities at a global level. (
  • Advanced Imagine-1 clinical trial for GM1 gangliosidosis to recruitment of final cohort, Cohort 4, in dose-ascending phase of study following recommendation by Independent Data Monitoring Committee. (
  • Safety data will be periodically reviewed by an Independent Data Monitoring Committee (IDMC). (
  • Merck last month stopped enrolling new participants in two of the trials after an independent data monitoring committee observed more deaths occurred among participants who received Keytruda in combination with another treatment than among participants in the studies' control groups. (
  • On November 3, GSK announced that they were halting enrollment of a new phase 3 trial in response to substantial positive findings, on the basis of a recommendation by the Independent Data Monitoring Committee (see Infographic). (
  • In the pivotal phase 3 clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee. (
  • In mid-April, at the recommendation of an independent data monitoring committee, AstraZeneca unblinded a phase 3 trial of Tagrisso two years early. (
  • The adverse event during phase I clinical trials during August 2020 was reported to the CDSCO-DCGI within 24 hours of its occurrence and confirmation. (
  • In November 2020, the company initiated a phase 2 clinical trial of ANX005 for treating HD patients. (
  • These units include a custom retrofitted recreational vehicle (RV) to support clinical development and, if approved, market demand, including our production estimates for 2020 and approximately 1. (
  • Based on its deep expertise in mRNA vaccine development and manufacture of health care products, including innovative medicines and biosimilars across more than a century ago by a man committed what do i need to buy spiriva to developing these novel vaccines with pre-clinical and clinical data at the 2020 Tokyo Olympics may become a symbol of a global supply. (
  • The Regional Committee is invited to endorse the proposed regional strategy to improve access to medicines and vaccines in the Eastern Mediterranean, 2020-2030. (
  • During December 2020, the vaccine was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA), and the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use among persons aged ≥18 years (1), which was adopted by CDC. (
  • Given the urgent public health need to address cVDPV2 in polio-affected countries, the vaccine is being made available through WHO's Emergency Use Listing (EUL) procedure since 2020.ii · nOPV2 is a live type 2 poliovirus and can currently be handled outside of GAPIII containment requirements for the purposes of production, quality control testing, clinical trials, stockpile, and outbreak response. (
  • Trial registration: NCT04251429 (retrospectively registered January 29, 2020), protocol version 1. (
  • This report includes data on the major clinical outcomes through April 30, 2002. (
  • ATMOSPHERE (Aliskiren Trial to Minimize Outcomes in Patients with Heart Failure) randomized more than 7,000 heart failure patients to the ACE inhibitor enalapril (Vasotec), aliskiren, or the combination of the two. (
  • Medical data and outcomes regarding emotional symptoms, disability, quality of life, and emotion regulation biases will be collected at baseline, immediately after treatment, and 6 and 12 months later. (
  • Digital health interventions' effectiveness vary across outcomes: clinical (mixed), behavioral (positively inclined), and service implementation outcomes (clear effectiveness). (
  • Pay for performance had no discernible effects on processes of care or on hypertension related clinical outcomes. (
  • Nutrition education with inclusion of peer to peer support was of clinical benefit in improving metabolic outcomes and reducing MetS in T2DM patients. (
  • Study outcomes will determine whether HealthLinks is an effective approach to increasing evidence-based health promotion in small , low-wage worksites and whether wellness committees are a capacity-building tool that increases HealthLinks' effectiveness. (
  • Process evaluation outcomes include fidelity of the HWPP intervention, extent of individual DT member activity, expansion of committee scope to include employee well-being, program obstacles and opportunities in each setting, and sustainability (within the available time frame). (
  • Simulation (patient data acquisition) guidelines. (
  • BACKGROUND: The Medical Research Council Guidelines for Good Clinical Practice outlines a three-committee trial oversight structure - the day-to-day Trial Management Group, the Data Monitoring Committee and the Trial Steering Committee. (
  • METHODS: A survey to establish Trial Steering Committee's current practices, role and the use and opinion on the Medical Research Council guidelines was undertaken within UK Clinical Research Collaborative registered Clinical Trials Units. (
  • We have identified a widespread adoption of Medical Research Council Guidelines for Trial Steering Committees in the United Kingdom, but limitations in this existing provision have been identified that need to be addressed. (
  • Serves as a point of contact activities related to monitoring adherence to DSMP and policies and procedures adopted by Winship Cancer Institute as required by the Cancer Center Support Grant Guidelines (CCSG). (
  • Coordinates and attends Data Safety and Monitoring Committee meetings in accordance with Cancer Center Support Grant guidelines to ensure the success of the Cancer Center's protocol review and monitoring process. (
  • and 3) to describe the positive and negative predictive values (PPV and NPV, respectively) of meeting the guidelines by calculating the percentage of women meeting the physical activity recommendation by the 7D-PAR who also met this recommendation based on data from the accelerometer. (
  • The self-reported data from the national surveys suggested that approximately 50 % of all adults met the 2008 Physical Activity Guidelines [ 5 ]. (
  • Devlin specifically advocates for clinical practice guidelines from the Infectious Diseases Society of America (IDSA), which is currently working on updated guidance for acute uncomplicated cystitis and pyelonephritis treatment. (
  • In 1996, the Department of Health and Human Services and the Henry J. Kaiser Family Foundation convened the Panel on Clinical Practices for the Treatment of HIV to develop guidelines for the clinical management of HIV-infected persons. (
  • These guidelines were developed by the Panel on Clinical Practices for Treatment of HIV Infection, convened by the Department of Health and Human Services (DHHS) and the Henry J. Kaiser Family Foundation. (
  • The guidelines contain recommendations for the clinical use of antiretroviral agents in the treatment of adults and adolescents (defined in Considerations for Antiretroviral Therapy in the HIV-Infected Adolescent) who are infected with the human immunodeficiency virus (HIV). (
  • As the FDA continues to develop evolving guidelines, our industry has experienced a sudden, paradigm shift towards hybrid and virtual trials, with telemedicine becoming the "norm" for patient interaction across a variety of therapeutic areas. (
  • Research efforts on the analytic validity, clinical validity and utility of cfDNA as a diagnostic and therapeutic biomarker have expanded in the past decade, yet very few applications fall into CDC Tier 1 classified guidelines (genomic applications with a level of evidence established for use in practice. (
  • Current National Comprehensive Cancer Network (NCCN) 2022 guidelines specific to NSCLC (V5.2022) advise plasma cell-free/circulating tumor DNA testing should not be used in lieu of histologic tissue diagnosis, although it can be considered in specific clinical circumstances (i.e., if a patient is not suitable for invasive tissue sampling, if insufficient material following pathologic confirmation or incomplete assessment of all recommended biomarkers in the initial diagnostic setting). (
  • A special panel session regarding the recent American College of Medical Genetics and Genomics (ACMG) guidelines for reporting incidental findings in clinical sequencing. (
  • This spiral-bound, 5" x 7.5" book is a compilation of the European Union Directives, implementing guidances and ICH guidelines governing the conduct of clinical research in the EU. (
  • PharmaLex customizes the monitoring and signal detection activities as per client requirements ensuring reliable, high quality, trackable data in compliance with the regulatory guidelines (e.g. (
  • Bharat Biotech said on Saturday that it had reported the adverse event that happened during the Phase I clinical trials to the drug regulatory body within 24 hours. (
  • In addition to the usual trial details, the NEJM publications contained a fascinating round of articles from the trial's Data Monitoring Committee, executives from drug sponsor Novartis, and officials from European regulatory agencies, offering their perspectives on the pandemonium that ensued when the drug began to fall. (
  • In a separate NEJM paper, members of the ATMOSPHERE Data Monitoring Committee- Karl Swedberg, Jeffrey Borer, Bertram Pitt, Stuart Pocock, and Jean Rouleau- issued a harsh condemnation of regulatory intervention in the trial. (
  • They wrote that they consider the regulatory action "to be a threat to the function of data monitoring committees [DMCs] and potentially to the integrity of monitored trials. (
  • Problems with aliskiren first emerged in the ALTITUDE trial, resulting in the early termination of the trial and a regulatory warning against use of the drug in diabetic patients. (
  • and 2) fulfilling the role of liaison to Committee Chairmen, Program Leaders, Principal Investigators, Regulatory Specialists, and Study Coordinators. (
  • Partnering with Training/Education to ensure monitoring trends are addressed within the clinical trials teams and regulatory and training/competency materials are revised to meet compliance standards. (
  • The importance of systematically involving patients from early development through regulatory process to ongoing monitoring and safe use in everyday healthcare. (
  • The problem of substandard and falsified (SF) medical products affects all countries but few regulatory authorities or pharmaceutical companies have policies of publicly releasing data. (
  • Clinical trial (CT) sites face a continually changing legal and regulatory landscape, making research conduct and program operations challenging. (
  • COLUMBIA, Md. , Jan. 25, 2023 /PRNewswire/ -- Advarra, the market leader in regulatory review solutions, clinical research technology for sites and sponsors, and research quality and compliance consulting services, announced today that Scott Hoffman has joined the company as Chief Commercial Officer. (
  • Human subjects research involving individually identifiable human specimens or data and subject to federal and state regulatory requirements. (
  • We offer biostatistical consulting focusing on clinical trials, Bayesian statistics, and strategic statistical communication for regulatory designs and filings. (
  • The name ConfluenceStat signifies the importance of having an experienced clinical trial statistician at the intersection, or confluence, of your executive, clinical and regulatory teams throughout drug or device development. (
  • The BERD Core provides training and assistance with research design, epidemiology, and biostatistics, including implementation of data collection tools and methods, data management and monitoring, and data analysis for manuscripts and grants, and it works with the Research Service Center to ensure that MCCTR investigators are thoroughly trained in regulatory principles and management. (
  • How this will affect clinical trials and regulatory approvals in the future remains to be seen, but there is reason to be optimistic. (
  • Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. (
  • Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight. (
  • Umer Raffat, a senior managing director at the investment bank Evercore ISI, wrote in an analyst note that the fact that Pfizer hasn't conducted an interim analysis was "a good thing" because it means that, based on the details of the trial protocol, the vaccine had not failed to prevent more than 77% of Covid cases, the benchmark for success at this early juncture. (
  • In that spirit, we are committed to decreasing health disparities in underrepresented populations through the clinical trial design allows for interim analyses and unblinded reviews by an independent external Data Monitoring Committee (DMC) at a high risk of exposure. (
  • Is there an interim analysis planned for this trial? (
  • In a complex clinical trial, data monitoring committee's oversee interim data to ensure adequate safety monitoring. (
  • In addition to initial clinical trial data, ACIP considered new information gathered in the 12 months since issuance of the interim recommendations, including additional follow-up time in the clinical trial, real-world vaccine effectiveness studies, and postauthorization vaccine safety monitoring. (
  • It said that it had submitted all documentation within timelines, and as mandated by the ethics committees and CDSCO, including a complete causality report. (
  • 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. (
  • The people who conduct clinical trials are called clinical researchers, or investigators. (
  • Investigators are usually doctors, but may be other health care professionals, who are paid to conduct the trials by the National Institutes of Health (NIH) or by a pharmaceutical, biotechnologic, or medical device company. (
  • Investigators may also conduct trials supported by professional organizations such as the American Diabetes Association or the American Heart Association. (
  • Investigators follow a detailed protocol (list of instructions) that dictates who is eligible to participate in the trial, what interventions will be given or used, how often participants will be evaluated, and how data will be collected. (
  • Dr. Holubkov also regularly teaches courses on the design and analysis of randomized clinical trials and mentors clinical investigators as well as students in the Masters of Statistics Program. (
  • D program involving Pfizer, BioNTech, clinical investigators, and study participants with symptomatic COVID-19 disease. (
  • Advarra advances the way clinical research is conducted: bringing life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety, technology, and collaboration. (
  • A clinical trial statistician who understands the clinical situation and effectively communicates with investigators, sponsors, regulators, patients, patient advocates, and other key stakeholders is vital to the success of a clinical trial. (
  • DXA,CV core), and research nutrition resources to ICTR investigators, based on merit and willingness to be actively monitored by the Translational Research Evaluation Committee (TREC) for study-specific milestones. (
  • BOOST- For junior investigators, first-time R01 awardees, K awardees, and KL2 scholars to generate pilot data for a larger grant submission or to supplement research funds for the K project. (
  • PROPEL- For established investigators who are performing early stage clinical trials, deep phenotyping studies, or studies that address Maryland health priorities. (
  • The objective of the MCCTR Pilot Project Program is to assist junior investigators in generating sufficient data to be competitive for extramural funding. (
  • From the onset of the pandemic, scientists have been openly sharing their data with investigators from other centers or countries. (
  • Thousands of clinical trials are conducted each year and may take place at a variety of locations, including universities, hospitals, clinics, doctors' private offices, and professional clinical research sites. (
  • What are the credentials and research experience of the trial doctor and trial staff? (
  • Adapted from The Center for Information and Study on Clinical Research Participation, . (
  • Join this webinar for a discussion of the ideal applications of microsampling in clinical research, including details on how to evaluate sample stability. (
  • Consent, then randomization will be performed by statistician at Clinical Research Secretariat, Institutional Review Board. (
  • PLOS Medicine publishes research and commentary of general interest with clear implications for patient care, public policy or clinical research agendas. (
  • The company is conducting Phase III clinical trials of Covaxin, in collaboration with Indian Council of Medical Research . (
  • His research focuses on Bayesian statistical methods for evidence synthesis, innovative clinical trial designs, real world analytics, and global decision-making. (
  • His teaching and educational efforts focuses on making complex Bayesian methods widely applicable and interpretable to the global clinical research community. (
  • CONCLUSION: We present the first survey reporting on practices within UK Clinical Research Collaborative registered Clinical Trials Units on the experience and remits of Trial Steering Committees. (
  • Dr Hana Hassanin is an associate professor and the Director of Surrey Clinical Research Facility. (
  • She is a clinical consultant for the Dementia Research Institute (DRI) at the Surrey Sleep Research Centre. (
  • Seek out new practice methods and principles, applying them to existing clinical research practices. (
  • The conclusion was made on the basis of findings of an unblinded Independent Data Monitoring Committee's (iDMC) preplanned examination of data from the phase III research. (
  • This trial aims to contribute to clinical practice research. (
  • Clinical research is a highly specialized and rapidly evolving field of expertise. (
  • Ready to Advance Your Clinical Research Capabilities? (
  • The positive safety data in the previous phase 1 study and in the ongoing phase 1/2a study gives us the confidence to now proceed to administration of 20 million cells, which based on our significant pre-clinical research is likely well within the dosing range where we would expect to see clinically meaningful improvement in these patients," said Dr. Edward Wirth, Chief Medical Officer of Asterias Biotherapeutics. (
  • Further data were provided via direct correspondence with staff at the RANZCR and the Trans-Tasman Radiation Oncology Group (TROG), the major RO research group in Australasia. (
  • These leadership appointments reinforce the company's focus on advancing clinical research through integrated solutions for sites, sponsors, and CROs and underscore Advarra's commitment to operational excellence. (
  • His expertise in building and leading collaborative, high-performing sales organizations will support our strategy of connecting the clinical research ecosystem globally by offering holistic, integrated solutions that provide transformational benefits to our customers. (
  • Hoffman commented, "I'm excited to join Advarra to enhance how the commercial organization engages with the clinical research industry and contributes to meeting the company's strategic goal of advancing clinical research to make it safer, smarter, and faster. (
  • Learn more on NIAID's Clinical Trial Research page. (
  • Research using human specimens or data. (
  • With increasing amounts of novel technologies becoming available and more patients taking part in remote health care monitoring, further evaluation and research into digital technologies is needed. (
  • Long-term use of digital devices is critical for successful clinical or research use, but digital health studies are challenged by a rapid drop-off in participation. (
  • In view of the fact that statistical research forms the base of executive planning to achieve measles elimination by 2010, we studied measles epidemiological indexes in Ghazvin city and its territories (as a pilot model) from April 1997 to April 2003 and compared our data with those for the Islamic Republic of Iran as a whole for the same time. (
  • Clinical registries are used for quality management and clinical research. (
  • Randomized controlled trials (RCTs) enable us to gain level I evidence for treatment strategies but have the disadvantage of well-defined subgroups as their target of research and a standardized environment that does not reflect clinical reality. (
  • While raising funds to support lung cancer research, LCFA will raise the public's awareness and serve as a resource for patients or anyone seeking answers, hope, and access to updated treatment information, scientific investigation, and clinical trials. (
  • BOOST and PROPEL awards are quarterly clinical research grants that award Clinical Research Unit (CRU) resources such as research space, specialized research nursing, imaging assistance (i.e. (
  • ETHICS AND DISSEMINATION: The study has Human Research Ethics Committee approval. (
  • The Mississippi Center for Clinical and Translational Research (MCCTR) is a partnership involving the University of Mississippi Medical Center, the University of Southern Mississippi, and Tougaloo College. (
  • The Professional Development Core oversees the Clinical and Translational Research Scholars Program, Mentor Academy, and Seminar Series. (
  • The RSC also provides administrative and logistical assistance to lower the barriers to research implementation and enhance the success of the MCCTR's clinical, translational, and community-engaged research. (
  • Understand a data strategy's role in clinical research and how enforcing one will benefit your studies. (
  • Download our white paper for practical strategies for enhancing innovation, efficiency, and talent development in clinical research. (
  • About BioNTech Biopharmaceutical New Technologies is a critical step forward in strengthening sustainable access to results from analyses of whole browse this site exome sequencing data from 300,000 research participants from the BNT162 program, and if obtained, whether or when considering continuing XELJANZ in patients with pre-existing severe gastrointestinal narrowing. (
  • Training Mentors of Clinical and Translational Research Scho. (
  • Dr. Pfund is researcher, Institute for Clinical and Translational Research and Wisconsin Center for Education Research, University of Wisconsin-Madison, Madison, Wisconsin. (
  • Ms. House is research project director, Research Education and Career Development, Institute for Clinical and Translational Research, University of Wisconsin-Madison, Madison, Wisconsin. (
  • Dr. Sorkness is professor, School of Pharmacy and School of Medicine, and senior associate executive director, Institute for Clinical and Translational Research, University of Wisconsin-Madison, Madison, Wisconsin. (
  • This project has been funded in whole or in part with federal funds from the National Center for Research Resources (NCRR), grant no. 1UL1RR025011, and the National Center for Advancing Translational Sciences (NCATS), grant no. 9U54TR000021, National Institutes of Health, through the Clinical and Translational Science Awards (CTSA) Program (University of Wisconsin-Madison). (
  • The consortium includes four academic centers (Amsterdam UMC, University of Utrecht, University of Amsterdam and Maastricht University), five companies (Winclove Probiotics B.V., Springfield Nutraceuticals, Microbiome Center, Biovis Diagnostics, Danone/Nutricia Research) and two citizen/patient organizations (My Data Our Health Foundation and the Holland Health Data Cooperative). (
  • Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. (
  • Greater transparency is needed so that researchers can independently assess a drug's safety and effectiveness and doctors can examine the data to ensure the appropriateness of their prescribing, while investigative journalists and civil society at large put public pressure on regulators and industry to improve their practices. (
  • The United States (US) Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) convened the regularly scheduled quarterly meeting of the Advisory Committee on Immunization Practices (ACIP) on February 24-25, 2021. (
  • Our second presenter is Dr. Kathleen Dooling, who is a co-lead for the Advisory Committee for Immunization Practices COVID-19 Vaccines Workgroup as part of CDC's COVID-19 response. (
  • An early version of the HIT system was introduced during the 2003 football season: four football players from Virginia Polytechnic Institute and State University, in Blacksburg, Va., were monitored through 35 practices and 10 games. (
  • During its February 2015 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended 9-valent human papillomavirus (HPV) vaccine (9vHPV) (Gardasil 9, Merck and Co., Inc.) as one of three HPV vaccines that can be used for routine vaccination ( Table 1 ). (
  • The advisory committee on immunization practices' recommendation for use of Moderna COVI. (
  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies. (
  • Teva is notifying trial sites to discontinue the higher doses immediately in both trials and will encourage participants to continue follow-up. (
  • Both trials, CONCERTO and ARPEGGIO, are continuing the lower-dose arms (0.6mg daily), and participants in the trials will be provided with an update to confirm re-consent for participation. (
  • Merck said FDA suspended the trials in response to data that showed trial participants who had received Keytruda were more likely to die than those who had received other treatments. (
  • Merck said FDA placed a full clinical hold on the two blood cancer trials in which the company had stopped enrolling new participants and a partial hold on the third trial. (
  • According to the Journal , Merck said a portion of participants in the third trial also will stop receiving Keytruda. (
  • 12 In the Cochrane meta-analysis, a subanalysis restricted to trial participants who actually reached the active phase of labour showed little or no effect on the caesarean section rate. (
  • The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination. (
  • Most hospitals and clinics across the globe reported that post the second quarter of 2021, clinical visits frequency for the diagnosis and treatment of HD has improved. (
  • The data were collated in February 2021. (
  • In January 2021, Pfizer announced that the Phase 2 clinical trials for product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. (
  • LILACS Brazil's evaluation and permanence criteria are compatible with LILACS regional criteria and were discussed and approved at a meeting of the LILACS Brazil Journal Evaluation and Selection Committee in March 2021 and have taken effect in July 2021. (
  • The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. (
  • There is yet to be in-depth consideration establishing the Trial Steering Committee's role and functionality. (
  • In special cases, the data monitoring committee's statistical analysis plan to deal with these concerns should be shared with the regulators. (
  • Committee chair sends letter to the investigator informing of the committee's decision, and includes any relevant comments. (
  • Dr. Thorlund sits on several clinical trial data monitoring committees and has been the principal statistician for over 50 completed clinical trials. (
  • We also provide expertise for sponsors seeking an experienced data monitoring committee (DMC) statistician . (
  • To address the urgent medical need during the 2014 to 2016 outbreak, the clinical development of the 2-dose vaccine regimen comprising of Ad26.ZEBOV and MVA-BN-Filo was accelerated. (
  • Based on an international symposium organized by the Medical School of the University of Duisburg-Essen (Germany) and held in January 2016, we discuss the opportunities and challenges of three specific areas, i.e., public-private partnerships, adaptive designs and big data. (
  • At the University of Pittsburgh, Dr. Holubkov was chief biostatistician for the NHLBI Registries of Percutaneous Coronary Interventions and the two NHLBI Bypass Angioplasty Revascularization Investigations (BARI), and he also directed the Coordinating Center for an industry-sponsored international randomized trial comparing two mechanical heart valves. (
  • While our data suggest that self-report could be used to identify a physically inactive sample, it would be likely to over-estimate the proportions of women who become active in one or both arms of trials of interventions promoting MVPA. (
  • NCCN reports ctDNA testing studies have shown high specificity but compromised sensitivity for detecting molecular biomarkers that guide therapeutic interventions, therefore data supports complementary testing to reduce turnaround time and increase yield of targetable alteration detection. (
  • This study is a three-arm randomized controlled trial testing the impact of the HealthLinks intervention on worksites' adoption and implementation of evidence-based interventions. (
  • Estrogen plus progestin component of the Women's Health Initiative, a randomized controlled primary prevention trial (planned duration, 8.5 years) in which 16608 postmenopausal women aged 50-79 years with an intact uterus at baseline were recruited by 40 US clinical centers in 1993-1998. (
  • Out of 17 centers willing to participate, 4 were still lacking any data entries. (
  • Due to the high inaccuracy, the high number of centers lacking mandatory entries at all and the number of false entries, these data alert us to advocate unannounced audits and further measures to improve the situation. (
  • As noted in the ACIP Policies and Procedures manual, Dr. Cohn reminded everyone that ACIP members agree to forgo participation in certain activities related to vaccines during their tenure on the committee. (
  • Members who conduct vaccine clinical trials or serve on data safety monitoring boards (DSMBs) may present to the committee on matters related to those vaccines, but are prohibited from participating in committee votes. (
  • Dr. Sharon Frey serves as a Principal Investigator on several COVID-19 vaccines trials. (
  • Responsible for the maintenance, revision and oversight for the Data Safety and Monitoring Plan (DSMP). (
  • Advarra designs your data monitoring committee to provide the appropriate independent oversight to support participant safety and statistical evaluations. (
  • She has served as PI on several NIH R01 grants, served on the Executive Steering Committees for international clinical trials and national registries, Event Adjudication Committees, and Data Safety Monitoring Boards. (
  • On May 31, 2002, after a mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits. (
  • He has taught a variety of courses at Cornell including Statistical Methods II, the second semester of a statistical methods sequence for graduate students from a wide variety of disciplines, Biological Statistics I, Data Science for All, as well as core courses for statistics undergraduates, professional masters students, and Ph.D. students in the Fields of Statistics. (
  • METHODS: De-identified data were provided from two recent FRO workforce censuses conducted in 2014 and 2018 with permission from the EWC. (
  • METHODS AND ANALYSIS: This open-label, seven-centre, randomised controlled parallel group clinical trial will compare home-based hybrid closed-loop versus standard diabetes therapy in Australia. (
  • A 2015 updated American College of Obstetrics and Gynecology (ACOG) Committee Opinion (Tier 2) recommended conventional screening methods as the most appropriate choice for first-line screening for most women in the general obstetric population since cell-free DNA screening has limitations in performance and limited data on cost-effectiveness in the low-risk obstetric population. (
  • In the literature we find data evaluating the installation of sympathetic block through HRV using linear methods however, there is a lack of studies using methods based on the domain of chaos. (
  • We ensure Signal detection methods applied are appropriate for the data set under analyses as qualitative analyses alone may not suffice for large data sets and complex statistical tools may not be appropriate for smaller data sets. (
  • With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/IWRS) expertise at our core, our services are scalable via our diverse and complementary strategic partnerships to provide full service clinical trial solutions. (
  • Study record managers: refer to the Data Element Definitions if submitting registration or results information. (
  • All study visits will consist of brief clinical examination (including vital signs), subjective adverse event reporting, and fasting donated blood and urine for clinical laboratory tests. (
  • The trial is expected to continue until 150 of the volunteers in the study have had Covid-19. (
  • Disseminates policy decisions and resolutions to Winship study teams from the Data Safety and Monitoring Committees. (
  • The informative lecture provided useful recommendations which included ensuring DSMB members are supportive of the trial and structuring the study team to maintain blind during the construction and review of DSMB reports. (
  • The SciStar study, funded in part by the California Institute for Regenerative Medicine (CIRM) is a Phase 1/2a clinical trial that is designed to test first the safety and then the effectiveness of Asterias' AST-OPC1 cells. (
  • This clinical trial is the first study to evaluate the effect of vitamin D dosing interval on susceptibility to acute respiratory infection. (
  • This study aimed to assess the determinants of competency levels for health workers who utilized data from health information systems in Eastern Ethiopia . (
  • GSK has announced that it will seek approval for gepotidacin and pursue peer-reviewed publication of study data early next year. (
  • The study used UK Biobank data, COVID-19 test results, and deaths recorded March-July. (
  • to know whether clinical trial rules and regulations will apply to your study. (
  • Sunitinib is also approved by the FDA for PNET, on the basis of a study that was discontinued after the independent data and safety monitoring committee observed more serious adverse events and deaths in the placebo group but an improvement in PFS in the sunitinib group. (
  • The aim of this study was to determine the accuracy and completeness of registry data o the example of the German Spine Society (DWG) registry. (
  • It assists applicants for MCCTR resources and MCCTR awardees through the Investigator Development Program and Pilot Projects Program with study design and execution, including instrument, protocol, and Manual of Procedure development, data coordination, analytics, and reporting. (
  • The study was approved by the Ethics Committee of the Kansai University of Welfare Sciences. (
  • As a clinical trial moves through phases, how does the return on investment benefit study design and the program overall? (
  • Data on MetS risk factors as well as food intake patterns and physical activity levels were taken at baseline and at different time points during the study. (
  • The results are "very encouraging," said Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, who was not involved in the trial, which he called a "very difficult study under very difficult circumstances. (
  • The purpose of this paper is to (a) describe the intervention design and study protocol of the HealthLinks Trial and (b) report baseline findings. (
  • The design seeks to achieve comparable study engagement and data quality between groups. (
  • Potential challenges include difficulty in pooling data across study sites if Design Teams select different intervention topics, and follow-up periods too short for change to be observed. (
  • Currently, Cellavita, in collaboration with AzidusPharma, is investigating stem cell therapy, CELLAVITA-HD in phase 2/ 3 ADORE-DH trial. (
  • Clinical trials require extensive collaboration and communication. (
  • In addition, the MCCTR pursues extensive collaboration with the IDeA-funded Louisiana Clinical and Translational Science Center and Mayo Clinic's Center for Clinical and Translational Sciences. (
  • Another positive note is that the pandemic has accelerated laboratory and clinical trial collaboration far beyond what has ever been seen before. (
  • Does the trial involve a placebo or a treatment that is already on the market? (
  • In this randomised, observer-blind, placebo-controlled Phase II trial, 668 healthy 18- to 70-year-olds and 142 HIV-infected 18- to 50-year-olds were enrolled from 1 site in Kenya and 2 sites each in Burkina Faso, Cote d'Ivoire, and Uganda. (
  • Where-as placebo-controlled randomized trials control trials remain the gold standard, in some situations synthetic control arms can be used instead. (
  • Synthetic control arms leverage real world data from various sources or evaluations of historical clinical data to demonstrate the positive effects of a new therapy or treatment , without the need to use a placebo or standard of care as a control. (
  • In a randomized trial of 240 women, 3 months of daily administration resulted in 56% of women avoiding UTIs for 1 year, compared with 25% of women treated with placebo. (
  • The placebo-controlled randomised trials that supported the temporary authorisation of these two antivirals were conducted in unvaccinated patients with COVID-19, so an evidence-based prescription practice would only use these drugs for unvaccinated patients until further data become available. (
  • In postsurgery patients with EGFR-mutated non-small cell lung cancer , Tagrisso cut the risk of disease recurrence or death by a whopping 83% compared with placebo, AstraZeneca revealed ahead of the American Society of Clinical Oncology's (ASCO's) virtual annual meeting. (
  • Merck on Wednesday announced that FDA has placed a hold on three clinical trials that were testing the company's drug Keytruda as a treatment for blood cancer. (
  • Following numerous parliamentary committees, auditor general reports, journalist investigations, and academic researchers calling for greater transparency, Health Canada has offered up several supposed transparency initiatives. (
  • The device would provide, for the first time, a data set large enough for researchers to understand when a concussion is likely to have occurred, according to how hard a hit was and to which part of the helmet. (
  • The researchers conducted a randomized clinical trial protocol to assess autonomic function at motor recovery in patients receiving spinal anesthesia with isobaric bupivacaine alone or clonidine-associated isobaric bupivacaine. (
  • W.H. Freeman and Company has published a printed version of Mentor Training for Clinical and Translational Researchers. (
  • Obtaining experience with this device in both the laboratory and clinical setting will help the user to gain knowledge about the advantages and disadvantages. (
  • Scandinavian Journal of Clinical and Laboratory Investigation. (
  • Public health scientists at CDC will collect and analyze epidemiologic and laboratory data to determine pandemic severity using the PSAF 1 . (
  • The change comes at the recommendation of the data monitoring committee (DMC) overseeing two active clinical studies in MS. The DMC identified an imbalance in the number of cardiovascular events in the studies. (
  • The Food and Drug Administration's (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) will review the WHO recommendation and make a recommendation to the Commissioner of Food and Drugs at FDA for viruses to include in the pandemic vaccine for the United States. (
  • Risk of fracture with thiazolidinediones: An up to date meta-evaluation of randomized clinical trials. (
  • The aim of this paper is to present the AEPC position on frequently asked questions regarding Covid-19 in a Paediatric and Congenital Cardiology setting, based on continuous monitoring and evaluation of scientific papers. (
  • evaluating and critically appraising ICSRs, aggregate data, and literature and thereby providing a comprehensive evaluation report considering the strengths and weaknesses of all the data sets and sources reviewed. (
  • Brazilian scientific journals are selected by the LILACS Brazil Journal Evaluation and Selection Committee, coordinated by BIREME, in support of the coordination activities of LILACS and VHL 3 Brazil networks, led by the Brazilian Ministry of Health. (
  • and receiving honoraria from Synlogic Medical Advisory Committee (personal honorarium). (
  • Advisory Committee (EAC). (
  • For these recommendations, ACIP reviewed additional data on 9vHPV in males aged 16 through 26 years ( 4 ). (
  • ACIP also considered comparisons of mRNA vaccine effectiveness and safety in real-world settings when first doses were administered 8 weeks apart instead of the original intervals used in clinical trials (3 weeks for BNT162b2 [Pfizer-BioNTech] COVID-19 vaccine and 4 weeks for Moderna COVID-19 vaccine). (
  • Such analyses are a standard part of clinical trials, and are conducted by an independent committee called a data and safety monitoring board, or DSMB. (
  • BIREME coordinates LILACS's International Journal Selection Committee, which endorses the titles selected by the National Selection Committees, periodically evaluates the titles indexed in LILACS, and promotes studies on Latin American and Caribbean scientific production. (
  • This phase I trial studies the safety of SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant together with sargramostim in treating patients with newly diagnosed multiple myeloma who are receiving lenalidomide maintenance therapy. (
  • The statement was issued following a report by Economic Times which revealed that a serious adverse event was seen in a case during the Phase I trial of its indigenous Covid vaccine. (
  • After completion of staging, the patient is informed about this trial after checking the eligibility checklist. (
  • The patient is informed about this trial, including the following main points: title and aim of the trial, nature of the treatment, side effects, reason for randomization, passing on of data and material samples and the patient's freedom to decide. (
  • The written consent to participate in the trial and to randomization, if needed, in the presence of a witness takes place at least 24 hours after patient briefing. (
  • Unlike other companies like AstraZeneca and Johnson & Johnson which had temporarily halted their phase 3 clinical trial immediately after an adverse event was observed in a patient, Bharat Biotech continued with the trial and the no public disclosure was made by the company. (
  • One event was observed in the 1.5-mg daily-dose arm of the ARPEGGIO trial in primary-progressive MS. ARPEGGIO has enrolled 191 patients and has 35 years of patient experience. (
  • expect to dose the final patient in this phase of the trial by year-endPlan. (
  • A median of 31 items per patient was evaluated including completeness and accuracy of data. (
  • Baseline data on duration of MVPA from the mPED trial were analyzed for 215 women. (
  • Several questions concerning vaccination remain unanswered and require further exploration, such as response duration, need for response monitoring and rates of breakthrough infections. (
  • Throughout the duration of the block, patients should receive constant monitoring. (
  • We conducted a randomised trial to assess the safety and the immunogenicity of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen in 3 different vaccination intervals in healthy and HIV-infected adults. (
  • Responsibilities include the following duties: Process, review, and assess SAE, device incident, and pregnancy reports from clients' ongoing drug or device clinical trials in a timely manner. (
  • What has already been learned about the trial treatment and have any trial results been published? (
  • The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD. (
  • RESULTS: Our results showed that compared to females, male radiation oncologists were more likely to be engaged in full-time active clinical work, hold a postgraduate degree and obtain a consultant or fellowship position following graduation. (
  • And these results are consistent with what was observed in the clinical trials and are essentially expected. (
  • Of 8866 results, 52 met eligibility criteria (31 reviews, 21 trials). (
  • Results of clinical trials conducted by HHS, and other available data, will be used to determine the appropriate formulation of a pandemic vaccine (e. g., specific virus(es), antigen content, whether an adjuvant is required, and dosage) and number of doses required to elicit a protective immune response. (
  • Clinical trial results will inform any adjustments needed in the targeting strategy and FDA-licensure of a pandemic vaccine. (
  • Such flames were fanned by two high-profile events last year: Eliot Spitzer's lawsuit against GlaxoSmithKline ( GSK ) for allegedly suppressing data linking antidepressants to suicide risk in children (which later prompted initiatives to disclose clinical trial results) and the recent scare over the safety of COX-2 inhibitors, a class of pain-killers, following the withdrawal by Merck of one of these called Vioxx. (
  • Results are easily recalled for review or data transmission. (
  • An experimental Ebola vaccine being tested in the West African nation of Guinea during the continuing outbreak of the viral disease has shown promising initial results, according to a report on the clinical trial that was published Friday. (
  • HealthLinks randomized controlled trial: design and baseline results. (
  • Patients who fit the eligibility criteria will be screened for the trial. (
  • Patients who consent to participate in the trial will be registered into the trial prior to the start of chemotherapy. (
  • Seven cardiovascular events were observed in patients receiving laquinimod daily at 1.2 mg for treatment of relapsing-remitting MS (RRMS) in the CONCERTO trial. (
  • The trial was significantly modified midstream when major safety concerns in patients with diabetes emerged in two other trials testing the drug, ALTITUDE and ASTRONAUT . (
  • Although they had not seen the data from ATMOSPHERE, the regulators intervened and asked Novartis to discontinue the use of aliskiren in diabetic patients in the trial. (
  • APPRAISE-2, one of nine clinical trials evaluating the drug, was expected to enrol 10,800 patients with a recent ACS. (
  • Primarily, they are focusing on the rolling submission of data for the prevention of stroke in patients with atrial fibrillation who are unsuitable for treatment with the gold standard warfarin to the US Food and Drug Administration and the application to the European Medicines Agency for venous thromboembolism prevention. (
  • News of the apixaban setback comes just after Bayer and Johnson & Johnson presented strong data for their rival drug Xarelto (rivaroxaban) at the American Heart Association meeting in Chicago, showing it was superior to warfarin, with less risk of bleeding, in protecting against stroke among patients with AF. (
  • 2This is the set of data generated by the subset of patients who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model. (
  • Oakland, CA - A clinical trial using stem cells to treat people with recent spinal cord injuries has cleared two key safety hurdles, and been given approval to expand the therapy to a larger group of patients with a much higher dose of cells. (
  • Asterias Biotherapeutics announced that its Data Monitoring Committee (DMC) has reviewed the safety data from the first two groups of patients treated and found no problems or adverse side effects. (
  • The patients enrolled in the trial have experienced injuries in the C5-C7 vertebrae and have essentially lost all feeling and movement below the injury site, with severe paralysis of the upper and lower limbs. (
  • At the same time, STRONG was planned to provide important data on age and sex matched normal values of controls and retinal vein occlusion (RVO) patients and the natural course of iCRVO and NVG in a very large and well-investigated cohort. (
  • The drug has already blitzed its way to the top of AstraZeneca's sales ranks, generating $3.19 billion in 2019 on the back of data in previously untreated metastatic EGFR lung cancer patients that made it the standard of care in that setting. (
  • CMS coverage has been approved under specific clinical scenarios for liquid biopsy for patients with lung cancer , as well NSCLC, colorectal, breast, and other solid tumors . (
  • A Canadian clinical guideline publication recommends liquid biopsy being performed first for the detection of EGFR T790M mutation in patients with EGFR sensitizing mutation-positive NSCLC who progress on first- or second-generation EGFR TKI therapy, followed up with tissue biopsy if the liquid biopsy is negative for T790M. (
  • Although patients diagnosed with or receiving therapy for cancer were excluded from the initial vaccine trials, emerging evidence now supports vaccine safety with potentially diminished immune response in this group. (
  • The data on cellular response are scarce and conflicting since not all studies have showed a difference between patients with malignancies and healthy subjects. (
  • The aim of this paper is to present the AEPC position on frequently asked questions based on the most recent scientific data, as well as to frame a discussion on how to take care of our patients during this unprecedented crisis. (
  • To better support patients' needs and advance the foundation's mission of accelerating the development and adoption of clinical indications, the FUS Foundation is transitioning the work of its Focal Drug Delivery Program to two other initiatives. (
  • AND Gaston Remmers: "Our joint proposal involved a structured approach to 'Learn to Fish' in the sea of ​​data and observations that patients make on a daily basis about their health. (
  • The project has dual leadership, divided between scientists and patients: Amsterdam UMC (science) and My Data Our Health Foundation (patients). (
  • The clinical trial involved inoculating people who had come into contact with Ebola patients, and the contacts of those contacts. (
  • Adults aged ≥25 years with type 1 diabetes using intensive insulin therapy (via multiple daily injections or insulin pump, total enrolment target n=120) will undertake a run-in period including diabetes and carbohydrate-counting education, clinical optimisation and baseline data collection. (
  • XELJANZ should be given to lymphocyte counts at baseline and after 4-8 weeks of treatment and for our industry will be followed for three additional years to monitor antibody persistence. (
  • Main outcome measures Centiles of systolic and diastolic blood pressures over time, rates of blood pressure monitoring, blood pressure control, and treatment intensity at monthly intervals for baseline (48 months) and 36 months after the implementation of pay for performance. (
  • and 3302 employees across the worksites participated in the baseline data collection. (
  • As Chief Operating Officer, Uebele is responsible for strategy and operations for Review Services, including institutional review board (IRB), institutional biosafety committee (IBC), data monitoring, and endpoint adjudication, Global Services and Product Delivery, Consulting Services as well as Advarra's customer success teams. (
  • If you still have questions about whether your application has human subjects, ask your institutional review board (IRB) or independent ethics committee (IEC) before writing your application. (
  • It might also have been possible, for instance, for Pfizer to have told the DSMB only to give it information if there is enough safety data to file for an EUA. (
  • Bristol-Myers Squibb and Pfizer have suffered a setback with the news that a late-stage trial of their investigational blood-clotting treatment apixaban has been stopped to an increase in bleeding. (
  • So we did have some data for Pfizer dose two, and we do have now data for Moderna dose two which is similar. (
  • However, this remains uncertain, as none of these registries have implemented independent monitoring. (
  • Registries were designed to acquire comprehensive data on treatment effects and natural course of diseases [ 1 ]. (
  • Thus, we look back on more than two decades of experience with data originating from registries, which are increasingly used for clinical science and quality management. (
  • Registries have the hypothetical advantage to acquire data from a complete population with a specific disease treated in a real-world setting. (
  • Thus, clinical studies with data from registries are considered to ideally complementing RCTs or vice versa. (
  • Data originating from clinical registries become also increasingly important today for quality management purposes to all stakeholders of our healthcare systems, e.g., health insurances, healthcare providers, politicians, professionals and their respective scientific societies. (
  • Because these two purposes are highly important and may have far reaching consequences, data quality of registries itself with regard to completeness and accuracy becomes of utmost importance. (
  • In strong contrast to this stands the fact that few spine registries have external monitoring, which would be a first prerequisite to assure data quality. (
  • Another obstacle for almost all registries with exception of the Scandinavian ones is that most national data protection laws require strictly anonymized data entries, which prohibits any relevant and accurate follow-up for very important markers such as reoperation rates or 30-day readmissions. (
  • Clinical trials are experiments designed to find out whether an intervention is safe and effective and that the potential benefits of the intervention outweigh the risks. (
  • Several thousand people typically participate in clinical trials for each new intervention before it becomes available to the general public. (
  • If legitimate concerns arise regarding the safety of any intervention, as was the case here, sharing of data with regulators should be avoided. (
  • Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. (
  • Analysis will be intention to treat, with the primary outcome time in continuous glucose monitoring (CGM) target range (3.9-10.0 mmol/L) during the final 3 weeks of intervention. (
  • This was a randomized controlled trial with two intervention groups and one control. (
  • The unit of intervention is a workplace health and safety committee, adapted here to a joint labor-management "Design Team" (DT). (
  • Objective To conduct a clinical trial of high-dose versus low-dose vitamin D 3 supplementation for ARI prevention in residents of sheltered-accommodation housing blocks ('schemes') and their carers in London, UK. (
  • In the event of insufficient information to validate a signal, cases with the event of interest are followed up for further information or conduct descriptive or analytical studies to reinforce the information to have a further understanding on the magnitude and clinical significance. (
  • COVID-19 treatment what do i need to buy spiriva should visit Lilly TrialGuide for information regarding eligibility for ongoing trials. (
  • The COVID-19 virus outbreak is disrupting the way clinical studies are performed, but they may have a better chance of continuation when remote/home sampling can be performed. (
  • Teva says it has completed large trials and is conducting long-term extension studies at the 0.6-mg dose, which is currently without cardiovascular concerns. (
  • She added that Teva has previously completed two phase 3 trials in RRMS (ALLEGRO and BRAVO) and continues long-term extension studies with laquinimod at 0.6 mg/day, which has not been associated with cardiovascular events. (
  • The 0.6-mg dose has been well tolerated in previous trials and long-term follow-up studies. (
  • Merck said the clinical hold does not apply to the other studies testing Keytruda for additional uses. (
  • FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings. (
  • PCP is often the initial clinical sign of HIV infection, particularly among infants. (
  • Bharat Biotech said that all adverse events were reported to the site ethics committee, CDSCO, data monitoring board and the sport. (
  • Clinical trials can also test whether treatments can help prevent disorders (for example, coronary artery disease, cancer, Alzheimer disease). (
  • Provides overall support and organization for all committee functions and responsibilities. (
  • ASSIST replaces the downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review. (
  • The doses of radiation used in these trials are heterogeneous ranging from 30-55 Gray(Gy). (
  • These units include a custom retrofitted recreational vehicle (RV) to support clinical development and manufacture globally up to 100 million doses worldwide by the Government of Canada to supply up to. (
  • Rationale Low-dose vitamin D supplementation is already recommended in older adults for prevention of fractures and falls, but clinical trials investigating whether higher doses could provide additional protection against acute respiratory infection (ARI) are lacking. (
  • He serves on several Data Safety Monitoring Boards and protocol review committees. (
  • Responsible for compiling agendas, assigning committee reviewers, composing official minutes, and constructing reports and correspondence in final form for Winship review committees, all of which are components essential to the success of the Core Grant. (
  • Given the growing importance of this issue, a working group was established under the Faculty of Radiation Oncology (FRO) of the Royal Australian and New Zealand College of Radiologists' (RANZCR) Economics and Workforce Committee (EWC) to review the current status of gender diversity within radiation oncology (RO) in Australia and New Zealand. (
  • They are unique within the ICTR in that awards are for CRU resources and applicants undergo a rigorous, NIH-style, multidisciplinary review process via the TREC review committee. (
  • Based on a review of safety and preliminary genetic stability data from initial campaigns held in Nigeria, Liberia, Benin and Congo, SAGE has endorsedi, a transition to the next rollout phase for the vaccine. (
  • European regulators wanted to examine blinded data from the ongoing ATMOSPHERE trial but the DMC resisted, though they reassured the regulators that they were carefully monitoring the trial and that they had not found evidence to warrant discontinuation of aliskiren in diabetics. (
  • Evidence on the effectiveness of these strategies is varied and there are concerns regarding the reliability of information, use of personal data, commercial exploitation of parents, and the effects of replacing caregiver presence with digital technology. (
  • The supporting data of the detected signal is evaluated with an aim to verify that the available evidence contains sufficient evidence indicating a potentially new causal association or a new aspect of a known association justifying a further analysis of the signal. (
  • In the afternoon Professor Steven Julious from University of Sheffield gave a very entertaining and enlightening lecture of his experience in designing clinical trials utilising an adaptive approach. (
  • Our experience includes all clinical trials, though we specialize in innovative trials, including Bayesian, adaptive, and platform trials. (
  • Adaptive trial designs are also increasingly discussed. (
  • Adaptive licensing can be a counter-part of adaptive trial design. (
  • The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. (
  • News about a potential new drug and findings related to prevention of recurrent UTI sparked interest, leading to this week's top trending clinical topic. (
  • Journal of Clinical Investigation. (
  • It also reflects our founder's unique background in biomedical engineering, statistics, and public policy and how that combination of experiences converges to provide insight into your drug or device development and to produce a successful, reliable, interpretable clinical trial. (
  • We strongly recommend that the data monitoring committee in a clinical trial be allowed to act independently during the progress of the trial. (
  • Independently verifies submitted protocols meet requirements for placement on committee agenda by reviewing submitted form, protocol priority diagrams, and protocols prior to assignment. (
  • Additionally, we provide TrialDX SM , a service to independently evaluate clinical trials for sponsors or investors. (
  • Experts in pediatric HIV infection (convened by the Pediatric HIV Resource Center) independently reviewed recent data and provided recommendations to the U.S. Public Health Service for PCP prophylaxis for HIV-infected or -exposed children. (