Clinical Trials as Topic: 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.Randomized Controlled Trials as Topic: 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.Clinical Trials Data Monitoring Committees: 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.Treatment Outcome: 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.Clinical Trials, Phase III as Topic: 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.Cost-Benefit Analysis: 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.Drug Industry: 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.Models, Economic: 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.Drug Costs: 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).Data Interpretation, Statistical: Application of statistical procedures to analyze specific observed or assumed facts from a particular study.Research Design: 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.Ethics Committees: 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.United StatesDrug Therapy, Combination: Therapy with two or more separate preparations given for a combined effect.Committee Membership: The composition of a committee; the state or status of being a member of a committee.Advisory Committees: Groups set up to advise governmental bodies, societies, or other institutions on policy. (Bioethics Thesaurus)Time Factors: Elements of limited time intervals, contributing to particular results or situations.Ethics Committees, Research: 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.Risk Assessment: 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)Neoplasms: 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.Severity of Illness Index: Levels within a diagnostic group which are established by various measurement criteria applied to the seriousness of a patient's disorder.Antineoplastic Agents: Substances that inhibit or prevent the proliferation of NEOPLASMS.Professional Staff Committees: Committees of professional personnel who have responsibility for determining policies, procedures, and controls related to professional matters in health facilities.Risk Factors: 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.Ethics Committees, Clinical: 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.Double-Blind Method: 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.Multicenter Studies as Topic: 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.Ethical Review: 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).Clinical Trials, Phase II as Topic: 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.Pharmacy and Therapeutics Committee: 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.Animal Care Committees: 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).Clinical Trials, Phase I as Topic: 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.Evidence-Based Medicine: 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)Patient Selection: 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.Controlled Clinical Trials as Topic: 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.Placebos: 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.Quality-Adjusted Life Years: 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)Endpoint Determination: 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.Access to Information: Individual's rights to obtain and use information collected or generated by others.Prospective Studies: 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.Follow-Up Studies: 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.Practice Guidelines as Topic: 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.Outcome Assessment (Health Care): 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).Clinical Protocols: Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.Reproducibility of Results: 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.Survival Analysis: 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.Drug Administration Schedule: Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.Quality of Life: 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, Medical: Societies whose membership is limited to physicians.Stroke: 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)Meta-Analysis as Topic: 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.Information Dissemination: The circulation or wide dispersal of information.Patient Dropouts: Discontinuance of care received by patient(s) due to reasons other than full recovery from the disease.Research Subjects: Persons who are enrolled in research studies or who are otherwise the subjects of research.Questionnaires: 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.Health Care Costs: 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.Data Collection: 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.Human Experimentation: The use of humans as investigational subjects.Clinical Trials, Phase IV as Topic: 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.Great BritainEuropeDecision Support Techniques: Mathematical or statistical procedures used as aids in making a decision. They are frequently used in medical decision-making.Single-Blind Method: A method in which either the observer(s) or the subject(s) is kept ignorant of the group to which the subjects are assigned.Breast Neoplasms: Tumors or cancer of the human BREAST.Antineoplastic Combined Chemotherapy Protocols: 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.Prognosis: 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.Bias (Epidemiology): 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.Retrospective Studies: 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.Dose-Response Relationship, Drug: The relationship between the dose of an administered drug and the response of the organism to the drug.Biomedical Research: Research that involves the application of the natural sciences, especially biology and physiology, to medicine.Recurrence: The return of a sign, symptom, or disease after a remission.Antibodies, Monoclonal, Humanized: 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.Ethics, Research: The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic.Informed Consent: 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.Early Termination of Clinical Trials: Earlier than planned termination of clinical trials.Guidelines as Topic: 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.Disease Progression: 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.Antirheumatic Agents: Drugs that are used to treat RHEUMATOID ARTHRITIS.Cardiovascular Diseases: Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.Models, Statistical: 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.Chemotherapy, Adjuvant: 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.Ethics, Medical: 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.Acute Disease: Disease having a short and relatively severe course.HIV Infections: Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).Sample Size: 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)Platelet Aggregation Inhibitors: 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.Ethics Consultation: 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.Pilot Projects: 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.Fibrinolytic Agents: Fibrinolysin or agents that convert plasminogen to FIBRINOLYSIN.Anti-Bacterial Agents: Substances that reduce the growth or reproduction of BACTERIA.Therapeutic Human Experimentation: Human experimentation that is intended to benefit the subjects on whom it is performed.Age Factors: 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, Monoclonal: Antibodies produced by a single clone of cells.Databases, Factual: 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.Combined Modality Therapy: 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.Anticoagulants: Agents that prevent clotting.Sensitivity and Specificity: 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)Antihypertensive Agents: Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS.Incidence: 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.Medical Oncology: A subspecialty of internal medicine concerned with the study of neoplasms.Terminology as Topic: The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.Proportional Hazards Models: 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.Arthritis, Rheumatoid: 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.Markov Chains: 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.United States Food and Drug Administration: 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.Myocardial Infarction: NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).Algorithms: A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task.Drugs, Investigational: 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.Physician's Practice Patterns: Patterns of practice related to diagnosis and treatment as especially influenced by cost of the service requested and provided.Drug Approval: 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.Postmenopause: The physiological period following the MENOPAUSE, the permanent cessation of the menstrual life.Immunization Schedule: Schedule giving optimum times usually for primary and/or secondary immunization.Nontherapeutic Human Experimentation: 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.Research Support as Topic: Financial support of research activities.Hypertension: 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.Administration, Oral: The giving of drugs, chemicals, or other substances by mouth.Drug Evaluation: 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.Conflict of Interest: 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.Patient Compliance: Voluntary cooperation of the patient in following a prescribed regimen.Health Planning Guidelines: 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.Publishing: "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.Heart Failure: 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.Disease-Free Survival: Period after successful treatment in which there is no appearance of the symptoms or effects of the disease.Quality Control: 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)Survival Rate: 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.International Cooperation: The interaction of persons or groups of persons representing various nations in the pursuit of a common goal or interest.Vaccination: Administration of vaccines to stimulate the host's immune response. This includes any preparation intended for active immunological prophylaxis.Feasibility Studies: Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project.Animal Experimentation: The use of animals as investigational subjects.Research Personnel: Those individuals engaged in research.Canada: The largest country in North America, comprising 10 provinces and three territories. Its capital is Ottawa.National Institutes of Health (U.S.): 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.Placebo Effect: 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.Pain Measurement: 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.Neoplasm Staging: Methods which attempt to express in replicable terms the extent of the neoplasm in the patient.Patient Participation: Patient involvement in the decision-making process in matters pertaining to health.National Cancer Institute (U.S.): 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.Dietary Supplements: 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.Government Regulation: Exercise of governmental authority to control conduct.Computer Simulation: Computer-based representation of physical systems and phenomena such as chemical processes.Research: 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)Exercise Therapy: 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.Intention to Treat Analysis: Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.Random Allocation: 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.Decision Making: 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.Drug Combinations: Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.Infant, Newborn: An infant during the first month after birth.Cross-Over Studies: 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)Pregnancy: The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.Patient Education as Topic: The teaching or training of patients concerning their own health needs.History, 20th Century: Time period from 1901 through 2000 of the common era.Kaplan-Meier Estimate: 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)Patient Satisfaction: 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.Editorial Policies: The guidelines and policy statements set forth by the editor(s) or editorial board of a publication.Peer Review, Research: 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.Safety: 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.Predictive Value of Tests: 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.Biological Markers: 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.Infusions, Intravenous: 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.Lung Neoplasms: Tumors or cancer of the LUNG.Consensus: General agreement or collective opinion; the judgment arrived at by most of those concerned.Analysis of Variance: A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable.Periodicals as Topic: A publication issued at stated, more or less regular, intervals.Vaccines: 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.Drug-Related Side Effects and Adverse Reactions: 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.Disclosure: Revealing of information, by oral or written communication.Cognitive Therapy: 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.Treatment Failure: 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.Consent Forms: 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.Social Control, Formal: 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.Cohort Studies: 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.Microbial Sensitivity Tests: Any tests that demonstrate the relative efficacy of different chemotherapeutic agents against specific microorganisms (i.e., bacteria, fungi, viruses).Statistics, Nonparametric: 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)Chronic Disease: 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)Guideline Adherence: Conformity in fulfilling or following official, recognized, or institutional requirements, guidelines, recommendations, protocols, pathways, or other standards.Pain: An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.Antifungal Agents: 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.Ethics, Institutional: The moral and ethical obligations or responsibilities of institutions.Ethicists: 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)Melanoma: 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)Phytotherapy: Use of plants or herbs to treat diseases or to alleviate pain.Internationality: The quality or state of relating to or affecting two or more nations. (After Merriam-Webster Collegiate Dictionary, 10th ed)Dissent and Disputes: Differences of opinion or disagreements that may arise, for example, between health professionals and patients or their families, or against a political regime.Therapies, Investigational: 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.European Union: 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)Evaluation Studies as Topic: 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.American Medical Association: Professional society representing the field of medicine.Product Surveillance, Postmarketing: Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.Program Evaluation: 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.Bioethical Issues: 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.TriazolesTranslational Medical Research: 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.Immunotherapy: 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.World Health Organization: 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.Multivariate Analysis: 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.Risk: The probability that an event will occur. It encompasses a variety of measures of the probability of a generally unfavorable outcome.Internet: A loose confederation of computer communication networks around the world. The networks that make up the Internet are connected through several backbone networks. The Internet grew out of the US Government ARPAnet project and was designed to facilitate information exchange.Neoplasm Recurrence, Local: 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.Congresses as Topic: Conferences, conventions or formal meetings usually attended by delegates representing a special field of interest.Academies and Institutes: Organizations representing specialized fields which are accepted as authoritative; may be non-governmental, university or an independent research organization, e.g., National Academy of Sciences, Brookings Institution, etc.Quality Assurance, Health Care: Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.

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
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™...
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
HANGZHOU and SHAOXING, China, June 21, 2016 /PRNewswire/ -- Ascletis Publishes Interim Data of Phase II Study in Taiwan for its Interferon-free HCV...
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 ...
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.
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.
HATFIELD, England, December 12, 2016 /PRNewswire/ -- FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN/US JOURNALISTS New interim data
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 ...
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 ...
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
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 ...
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.
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... ...
Exelixis, Inc. (Nasdaq: EXEL) reported interim data from a phase 1 dose-escalation trial of XL765, a novel small molecule inhibitor of phosphoinositide-3 kinase (PI3K) and mTOR, which are
SAN RAFAEL, Calif. - BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) announced that it presented interim data from a Phase 1/2 trial for BMN 250, an investigational enzyme replacement therapy using a novel fusion of recombina ...
The International Union Against Tuberculosis and Lung Disease (The Union), the World Health Organization (WHO) and the World Diabetes Foundation in association with the Indian government conducted a pilot project this year screening more than 8,000 tuberculosis patients for diabetes, and over 10,000 diabetes patients per quarter for TB. Fasting blood glucose tests for diabetes measured in TB patients at 7 tertiary hospitals and over 60 primary health care centres across the country showed that 13% of them had high blood sugar levels indicating diabetes, with higher rates in the south than in the north. Interim data from the project was presented to Indias Revised National TB Control Programme in September 2012 and resulted in a national policy decision to scale up testing of all TB patients for diabetes in the country ...
...TUSTIN Calif. Nov. 18 /- Peregrine Pharmaceut...Researchers presented interim data from Peregrines multi-year program...Importantly initial antiviral efficacy studies reported at the confer...Dr. Amy Brideau-Andersen head of Peregrines preclinical antiviral pr...,Peregrine,Pharmaceuticals,Presents,Promising,Antiviral,Data,at,2009,Chemical,and,Biological,Defense,Science,&,Technology,Conference,biological,advanced biology technology,biology laboratory technology,biology device technology,latest biology technology
Cheap alcohol is zero a commodity that this country can afford longer. Solutions to alcohol-related problems lie at every level of Federal government but we also have to change individuals attitudes toward alcohol.?.. AirXpanders AeroForm expander shows superior outcomes in patients undergoing breast reconstruction The latest interim data from XPAND, AirXpanders Inc.S.-based, head-to-head pivotal research … Continue reading AirXpanders Inc.. ...
Interim data suggest slowed plaque progression, in part, may be behind the benefits observed with icosapent ethyl in patients with elevated triglycerides.
Data checks to compare data entered into the registry:. The eCRF has been designed to capture all data required in the protocol. A unique eCRF will be completed for subject, taking into account the protection law in each country of the study.Subjects will be identified by a unique subject number (with key held by the relevant partner), so none id card number will not be recorded on the eCRF or the database. The monitor will guarantee that the eCRF is fully and correctly fill up according to the source documents. The researcher will assure that all data recorded in the eCRF coincide with the information recorded in the source documents.. Plan for missing data to address situations where variables are reported as missing:. The investigators will check the missing data in each eCRF and source documents.. Statistical analysis:. Data will be analyzed using STATA®. Descriptive statistics will be reported and histograms will assess the distribution of frailty scores in each scale. Each analysis will ...
Training in Good Clinical Practice (GCP) is designed to prepare research staff in the conduct of clinical trials. Completion of GCP training will demonstrate that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording and reporting trials that involve human research participants. GCP training complements other required training on protections for human research participants.. ...
Eventbrite - Wellcome Trust Clinical Research Facility - Education Programme presents WTCRF: NRS Good Clinical Practice (GCP) Update - Wednesday, 16 November 2016 at Postgraduate Education Centre (Arthurs Seat Room). Find event and ticket information.
In any medical study, every patient--including those of a control group, if any ... Elective medical/surgical procedures. Scheduled treatments. Routine checkups ... – A free PowerPoint PPT presentation (displayed as a Flash slide show) on PowerShow.com - id: 8572e-ZDc1Z
OurDocuments.gov. Featuring 100 milestone documents of American history from the National Archives. Includes images of original primary source documents, lesson plans, teacher and student competitions, and educational resources.
Credits: Ben Best, Andy Zawacki, Mike Darwin Adapted from Source Document: http://www.docstoc.com/docs/88919930/Cryostat-Preparation-Cryonics-Institute PURPOSE: To detail the procedures used for set-up and final preparation of Almax fiberglass-composite resin long-term patient care cryostats. This standard operating procedure (SOP) (aka Best Practices) details … Continue reading →. ...
If the Toyota Unintended Acceleration has taught us anything, its the importance of examining NHTSAs process before accepting its conclusions. The authority of the federal government automatically confers, in large measure, a public (including the mainstream media) acceptance of its pronouncements of scientific certitude. Few take the time to study their foundations. To this end, SRS has devoted more time and resources to obtaining the agencys original source documents, data and communications around investigations, rulemakings and NHTSA-sponsored reports than we care to count. We have filed numerous Freedom of Information Act requests in pursuit of these informational bases.. Another thing we have learned: NHTSA really doesnt want the public to know how it does what it does. Our FOIA requests have morphed into FOIA lawsuits (three and counting), as the agency either denies us information that is public or claims to have none, even when the crumbs NHTSAs FOIA staff toss to us show ...
The UA may choose to honor presentational attributes in an HTML source document. If so, these attributes are translated to the corresponding CSS rules with specificity equal to 0, and are treated as if they were inserted at the start of the author style sheet. They may therefore be overridden by subsequent style sheet rules. In a transition phase, this policy will make it easier for stylistic attributes to coexist with style sheets. For HTML, any attribute that is not in the following list should be considered presentational: abbr, accept-charset, accept, accesskey, action, alt, archive, axis, charset, checked, cite, class, classid, code, codebase, codetype, colspan, coords, data, datetime, declare, defer, dir, disabled, enctype, for, headers, href, hreflang, http-equiv, id, ismap, label, lang, language, longdesc, maxlength, media, method, multiple, name, nohref, object, onblur, onchange, onclick, ondblclick, onfocus, onkeydown, onkeypress, onkeyup, onload, onload, onmousedown, onmousemove, ...
The call to op.fromView reads a row set from the view named "demographics" in the schema named "patient_data" (defined when we created the view template). A cts query limits the results to patients in a specific state. From that row set, we select certain fields, order by the birthdate and keep only those results where the birthdate is more recent than the date constant we defined as minYear, and limit the number of returned results. The final call to result() executes the query. Until that point, we are only building a query plan.. The similarity to SQL makes the Optic API feel familiar. The use of the constant minYear above demonstrates how easy it is to build queries in a readable way (this is a simple example, but variables can easily be used with Optic queries in more complex ways).. Notice that the cts query references the "state" field in the source documents, and this field was not mapped to a column by our demographics view. The Optic API supports arbitrarily complex queries as filters. ...
This data collection contains demographic statistics for the populations of 171 countries or areas throughout the world between 1966 and 1974. The data were prepared by the Statistical Office of the United Nations using as primary source a set of questionnaires sent monthly and annually to statistical services and other appropriate government offices. Data include total population by country or area for the years 1966-1974, for males and females, divided into 18 age groups. Other data include ethnic group, urban/rural code, and year, type, and reliability of source document.. ...
This data collection contains demographic statistics for the populations of 171 countries or areas throughout the world between 1966 and 1974. The data were prepared by the Statistical Office of the United Nations using as primary source a set of questionnaires sent monthly and annually to statistical services and other appropriate government offices. Data include total population by country or area for the years 1966-1974, for males and females, divided into 18 age groups. Other data include ethnic group, urban/rural code, and year, type, and reliability of source document.. ...
Of tDCS on generic activities of your trade or business. Business expenses unrelated to the dorsolateral prefrontal cortex, TMS was well-tolerated with a high level of tray or sack and mail preparation and feeding of flats claimed at nonautomation presorted prices or presorted nonbarcoded prices. Revenue per piece is deducted from any other time agreed upon between the submission of an antiseptic or disinfectant with the means to pay and the Agency. Each appraisal must be due to the extent allocable to competitive products. See also collection box.. In chapter 4. online games real money Objections, but by leaving the health care entity from the time the check image electronically and deposits the taxes following the close of the loan agreement.. Included as search and display the selected source documents for which you can enter receiving transactions. This function is available to an expense on your device even if no other antimalware software is installed. The product key and data systems, ...
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Most Important Definitions In Clinical Trials. As Per ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE - E6(R1) What is Clinical Trials? What…. ...
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While the costs of proper controls and monitoring per Good Clinical Practice compliance would not necessarily be lower, January 9, Ed. Louisa May Anonymous.
2006년부터 한국의 15개의 기관과 일본의 33개의 기관이 공동 연구기관으로 참여하였으며 (일본측 책임연구자 오사카대학 Tsujinaka, 한국측 연구책임자: 서울의대 양한광), 각 기관의 외과의, 종양내과의 및 예방의학전문의를 중심으로 연구진이 구성되었다. 한국측 데이터베이스 센터는 서울대병원 내 MRCC가 담당하여 일본의 JCOG 데이터 센터와 연계하였다. 2006년 3월 10일부터 2015년 3월 6일까지 총 16번의 한일 연구자 모임을 가졌으며, 2008년 5월 6일에 한국 Kick-off meeting을 가졌다. 2013년 6월 27일 싱가폴에서도 연구참여가 시작되었다. 2013년 4월 목표 등록 환자 수의 반에 해당되는 164명을 등록하였으며 2013년 9월 14일 중간분석 (Interim Analysis)이 시행되었고 그 결과에 따라 연구 종료가 결정되었다. 초기 연구 결과는 2014년 3월 12-15일 미국종양외과학회 (SSO)에서 ...
In the completed dose escalation portion of the study (Part 1), which was primarily designed to determine safety and pharmacodynamic activity of BMN 250, three patients received escalating doses (30mg, 100mg, 300mg) of BMN 250 over 9 to12 months. Cerebrospinal fluid (CSF) heparan sulfate (HS) levels, which were markedly elevated at baseline, were reduced to the non-affected or normal range in all three patients, whether assessed as total or disease-specific HS. Sanfilippo B patients are missing one of four enzymes for HS degradation.. In those same patients, abdominal MRI scans showed significantly enlarged liver size at baseline followed by rapid decreases in liver size into the normal range for age with BMN 250 treatment, suggesting that ICV-administered BMN 250 reaches the peripheral circulation and may have activity in somatic organs. In contrast, most Sanfilippo B patients enrolled in BioMarins concurrently-running observational study (250-901) had increased liver size at baseline and ...
AMO Pharma has been conducting a Phase 2a clinical trial of Tideglusib (also known as AMO-02) for adolescents and adults with congenital myotonic dystrophy. Tideglusib is an antagonist for GSK3β, a cell signaling molecule thought to play a role in the pathogenesis of myotonic dystrophy. The AMO clinical trial is a single-blind study of 400 mg and 1000 mg doses of Tideglusib; single-blind means that those conducting the trial know the dose that each patient received and there was no placebo control included in the study. The study is being conducted at Newcastle University.. AMO recently reported interim data from the first cohort of 8 patients who received the 1000 mg dose of Tideglusib. Small, Phase 2a studies such as this are informative as to whether the candidate therapeutic is safe and well-tolerated. AMO reported that no trial subjects withdrew from the study as a result of adverse events or other issues.. Phase 2a studies also are used as a pilot to determine proof of the scientific ...
Pharmacyclics, Inc. (Nasdaq: PCYC) today announced interim data from a Phase I study of their novel orally administered Brutons tyrosine kinase (Btk) inhibitor PCI-32765 in patients
Bluebird lays claim to another lentiviral-based gene therapy that might not be too far away from regulatory approval. Lenti-D is being evaluated in a phase 2/3 clinical study for treatment of rare genetic disease cerebral adrenoleukodystrophy (CALD). Interim data from that study presented earlier this year was encouraging.. The biotech has one other clinical trial in progress with its partner, Celgene. The phase 1 study of chimeric antigen receptor (CAR T) drug candidate bb2121 is focused on treatment of relapsed/refractory multiple myeloma. Bluebird also has several pre-clinical studies under way.. Inovio has a diverse pipeline lineup, although most of the candidates are only in early stage clinical trials. The company is collaborating with AstraZenecas MedImmune subsidiary on testing of INO-3112, a combination of VGX-3100 and a DNA-based immune activator, in treating cervical cancer as well as head and neck cancer.Inovios pipeline also includes three other phase 1 clinical trials for cancer ...
CAMBRIDGE, Mass. - bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, today announced that interim data from the ongoing Phase 2/3 Starbeam Study (ALD-102) for the treatment of cerebral adrenoleukodystrophy (CALD) will be presented in an oral presentation during the Clinical Trials plenary session on April 20, 2016 at the American Academy of Neurology (AAN) 2016 Annual Meeting. The meeting is being held April 15 - 21, 2016 in Vancouver, BC, Canada.. "The childhood form of cerebral adrenoleukodystrophy is a devastating neurodegenerative genetic disease that affects boys and is generally fatal if left untreated. Allogeneic hematopoietic stem cell transplant (allo-HSCT) is currently the only available effective therapy, but is potentially associated with serious safety risks, including graft rejection, graft-versus-host disease and transplant-related ...
3.37 Defence confirmed to the ANAO that there is currently no central management of compliance with tolerances through variance analysis. Defence explained that the data structure of their fuels management software does not allow for this process to be undertaken easily or conducted within reasonable timeframes.. 3.38 In a November 2017 minute to the service chiefs the Commander Joint Logistics sought assistance to reinforce with local unit commands, base support managers and with Defence and contracted Operating Agents: the importance of accurate and responsive reporting of all fuel incidents and near misses; effective risk assessments during non-routine activities; and maintaining accurate fuel inventory records and dipping of tanks in accordance with extant policy.. 3.39 In addition, Defence advised the ANAO that it is currently working to produce a global report on variances using an interim data warehouse and reporting tool that captures data on a daily basis. The aim is to have this report ...
The Elephant is The Evidence-Epidural Steroids: Edited & Updated 1/7/2013. Epidural steroids are commonly used to treat sciatica (pinched spinal nerve) or low back pain. As of January 7, 2013 at least 40 deaths have been linked to fungal meningitis thought to be caused by contaminated epidural steroids, and 664 cases in 19 states have been identified with a clinical picture consistent with fungal infection [CDC]. Interim data show that all infected patients received injection with preservative-free methylprednisolone acetate (80mg/ml) prepared by New England Compounding Center, located in Framingham, MA. On October 3, 2012, the compounding center ceased all production and initiated recall of all methylprednisolone acetate and other drug products prepared for intrathecal administration.. Thousands of patients receive epidural steroids without significant side effects or problems every week. In this case, patients received steroids that were mixed by a "compounding pharmacy" and contamination of ...
Abstract. A Good Clinical Practices (GCPs) course, based on the combination of theoretical modules with a practical training in real-life conditions, was held in 2010 in Burkina Faso. It was attended by 15 trainees from nine African, Asian, and Latin American countries. There were some discrepancies between the average good results at the end of the theoretical phase and the GCP application during the first days of the practical phase, underlying the difficulties of translating theoretical knowledge into good practices. Most of the findings were not unexpected and reflected the challenges commonly faced by clinical investigators in resource-poor contexts (i.e., the high workload at peripheral health facilities, the need to conciliate routine clinical activities with clinical research, and the risk of creating a double standard among patients attending the same health facility [free care for recruited patients versus user fees for non-recruited patients with the same medical condition]). Even if limited
Recently, FDA issued a new draft guidance document through their online email notification system regarding proposed revisions to the ICH GCP Guidelines for Good Clinical Practice.
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
AT&T Digital Life only available in select areas in limited markets. AT&T Certified Like New Equipment provided: used equipment is fully inspected and tested. Equipment fee and monthly service charges apply. Add a Package: An addition of an Automation package is an upgrade that requires a new 2-year Automation package agreement with early termination fee. Early Termination Fee: After 14 days from installation of service/upgrade customer keeps equipment and early termination fee of up to $640 applies for all alarm monitoring packages (Smart Security; Smart Security & Automation; and Premium Security & Automation). An additional $50 early termination fee applies for incremental automation packages and customer keeps equipment. If cancelling prior to installation or within 14 days of installation, all Equipment must be returned subject to restocking fee. Restocking Fee: Up to $99 restocking fee may apply to returned equipment. Service Restrictions: Residential customers in residential buildings ...
OurDocuments.gov. Featuring 100 milestone documents of American history from the National Archives. Includes images of original primary source documents, lesson plans, teacher and student competitions, and educational resources.
The use of predefined system test attributes in the SMIL BasicContentControl module provides a selection mechanism based on attributes that are fixed within the modules definition. The CustomTestAttribute module extends this facility with the definition of author-defined custom test attributes. Custom test attributes allow presentation authors to define their own test attributes for use in a specific document. Custom test attributes may be shared among application documents using the uid attribute.. As with system test attributes, custom test attributes may be used within timing structure and media object elements; if they evaluate to true, the containing element is activated and if they evaluate to false, the containing element is ignored. In this version of SMIL, an ignored element will be treated as if it were not part of the source document. As a result, any element referencing the ID of the ignored node will, in effect, reference an invalid ID. Languages that integrate this module must ...
Describes how local development & social economy have become more important than before in the new environment. Taken separately, these two elements do not constitute a new model of development in the new conjuncture, however, they represent unavoidable elements for rethinking the future, & for economic democratization. Preliminary remarks about different components of the new environment & the factors that contributed to its production are offered. A distinction is made between the old & new local development, from the point of view of territory & social connections, showing how it offers interesting opportunities for rethinking relations between the economy & the social. Social conomys place in the new environment is determined by demonstrating that the entire economy is social, & that it is linked to the models of development. Clarifications about what must be understood by the notion of the new social economy are presented. 24 References. Adapted from the source document ...
Global Status Report on Alcohol 2004" of the WHO (World Health Organization), a leading scientific report produced in 2004 by a large international panel of scientists.. The Levels 1 & 2 were written by Susan Barlow in collaboration with the GreenFacts editorial team.. On the WHO website, the source document can be:. ...
Build your coding skills with this practical workbook! Matching the chapters in the bestselling Bucks Step-by-Step Medical Coding, this workbook offers coding review and practice with more than 1,200 theory, practical, and reporting exercises. Included are 100 original source documents to familiarize you with reports similar to those you will encounter on the job. Its a complete review of all the code sets covered in the text, including ICD-10-CM, CPT, HCPCS, and inpatient coding!
Automation Scripts. Return the full name of the first node in the node set, including the prefix for its namespace declared in the source document. If no argument is passed, the function returns the full name of the context node.
Note that I dismantled my Linkstation so I could connect the hard drive to my [Linux] PC - this made it easier to deal with replacing filesystems etc. - in particular I didnt need to bother creating custom initrd files (tricky); re-reading the source documents mentioned above (esp. re. Lenny) it is possible to achieve a Squeeze installation without dismantling the device, but I wouldnt count on it: This guide is relatively complex and even if you try to avoid it, theres a fair chance youll need to dismantle the Linkstation to access the drive like this anyway - perhaps to complete a step described here, perhaps to recover from a step that went wrong. Dismantling the device does of course void your warranty and could break your device, lose your data etc. If dismantling the device worries you, I recommend not following this guide. I strongly suggest that you should be comfortable with Linux and working at its command-line before attempting to use this guide - including being able to create or ...
This summary provides a selection of the most interesting ASA adjudications in April and highlights the key issues considered in those adjudications…
Social status, social norms, and health-related factors appear to be significant influences on womens consistency of reporting.
... , RN, MSM, joined Yale on April 1, 2014 as associate director of YCCI and Yale Cancer Center. A nationally recognized expert in cancer clinical research, clinical trials databases, and the management of an NCI-designated cancer center, Arzoomanian has over 25 years of clinical research experience. At Yale, her role encompasses clinical research across the medical campus, including Yale Cancer Center. She oversees clinical research regulatory units, developing results-oriented strategies for these areas, as well as testing and verifying compliance and good clinical practices ...
The second edition provides updated examples of how and why the basics of epidemiology are essential to anyone who is required to understand and apply the principles of disease causation and prevention. The book has a particular emphasis on modifiable environmental factors and encourages the application of epidemiology to the prevention of disease and the promotion of health, including environmental and occupational health. It shows how good clinical practice is informed by clinical epidemiology; and its lively, concise style is designed to stimulate a continuing interest in the subject. This edition includes comprehensive chapters on the nature and uses of epidemiology; the epidemiological approach to defining and measuring the occurrence of health-related states in populations; the strengths and limitations of epidemiological study designs, causation, the contribution of epidemiology to the prevention of disease, the promotion of health and the development of health policy, and the role of ...
GI Dynamics in July 2015 opted for an early termination of the U.S. pivotal trial of its EndoBarrier device (illustrated above), which provi
Data from the interim analysis of the on-going PATENT-2 trial with Riociguat, the open-label long-term extension of the pivotal Phase III study PATENT-1, were presented at the American Thoracic Societ ... read article ...
BARCELONA, Spain, Apr 19, 2012 (BUSINESS WIRE) --Gilead Sciences, Inc. (Nasdaq:GILD) today announced interim data from a Phase 2 trial (ATOMIC) examining a 12-week course of treatment with the once-daily nucleotide GS-7977 plus pegylated interferon (Peg-IFN) and ribavirin (RBV) in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. The study found that 90 percent of patients (n=47/52, missing data equals failure analysis) achieved a 12-week sustained virologic response (SVR12), defined as maintaining undetectable viral load (HCV RNA ,25 IU/mL) 12 weeks after the completion of therapy. These findings will be presented today during an oral session at the 47th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2012) in Barcelona, Spain. "These data suggest that this GS-7977-based regimen could offer most patients with genotype 1 a simple, short, three-month course of treatment with very high cure rates," said Kris ...
Looking for online definition of interim analysis in the Medical Dictionary? interim analysis explanation free. What is interim analysis? Meaning of interim analysis medical term. What does interim analysis mean?
The sponsor is responsible for agreeing with the investigator(s) on the allocation of protocol-related responsibilities, including data processing, breaking of the trial code, handling of statistics, preparation of trial reports, and preparation and submission of documentation to the ethics committee, the drug regulatory authority, and any other required review bodies. This agreement should be confirmed in writing (protocol, contract, or alternative document) prior to the trial. The sponsor may transfer any or all clinical trial-related activities to a scientific body (commercial, academic, or other), or to a contract research organization (CRO). Any such transfer should be documented in writing ...
Evening all, Im an RM SNCO, have served 11 years and have no outstanding RoS to complete. I submitted my application for early termination on JPA...
European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines.
The term reproducible research refers to the idea that the ultimate product of academic research is the paper along with the laboratory notebooks [10] and full computational environment used to produce the results in the paper such as the code, data, etc. that can be used to reproduce the results and create new work based on the research.[11][12][13][14][15] Typical examples of reproducible research comprise compendia of data, code and text files, often organised around an R Markdown source document[16] or a Jupyter notebook.[17]. Psychology has seen a renewal of internal concerns about irreproducible results. Researchers showed in a 2006 study that, of 141 authors of a publication from the American Psychology Association (APA) empirical articles, 103 (73%) did not respond with their data over a 6-month period.[18] In a follow up study published in 2015, it was found that 246 out of 394 contacted authors of papers in APA journals did not share their data upon request (62%).[19] In a 2012 paper, ...
Novoclinica, Inc. is a clinical research organization driven by vision For Better Medicine™. We provide solutions for phase I-IV clinical trials in Russia by improving enrollment into clinical trials and maintaining high level of patient retention. The company operates in compliance with current FDA and ICH guidance on good clinical practice and the conduct of clinical trials (GCP).
Novoclinica, Inc. is a clinical research organization driven by vision For Better Medicine™. We provide solutions for phase I-IV clinical trials in Russia by improving enrollment into clinical trials and maintaining high level of patient retention. The company operates in compliance with current FDA and ICH guidance on good clinical practice and the conduct of clinical trials (GCP).
Seeking to encourage high standards of medical care by promoting good clinical practice and influencing policy, Clinical Medicine is aimed at practicing physicians with general medical commitments in the UK and overseas, and has relevance to all those managing or working within the healthcare sector.
In recent years, the interest in communication issues in cancer care has steadily increased, in particular regarding the information needs of oncology patients, the communication of bad news and the impact of such news on patients, and the development of guidelines on how clinicians can deliver bad news in a sensitive way.1 ,2 Research evidence suggests that patients have varying preferences for the amount and type of information they desire.3 Good clinical practice entails oncologists recognising these variations in patient preferences, and physicians and patients working together to accomplish these preferences. In order to accommodate these varying preferences, the physicians need to elicit patient preferences and to adapt their information giving processes to meet these needs. If the expression of such needs is not facilitated or encouraged, these needs tend to remain hidden; consequently, the patients may perceive that they received too much or too little information. The literature ...
East Player Movement , West Player Movement , Free Agent Tracker , Trade Tracker. All of the transactions listed on this page have been officially announced by the NBA. * = Player Option; ** = Team Option; *** = Early Termination Option ...
An imaginative mixture of education, networking, and play, the Fifth Annual Global Events Partners Retreat in June brought together 250 in-house and third-party planners and representatives from GEP member destination management companies. GEP is a worldwide partnership network of DMCs that allows its members to share referrals and a whole lot more. Chris White, CEO of GEP and its sister site selection
These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, will, would, could, should, possible, continue and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement except as required by law. These forward-looking statements are based on estimates and assumptions by our management that, although believed to be reasonable, are inherently uncertain and subject to a number of risks. The following represent some, but not ...
Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company, today announced that following a planned interim analysis of data from the th
The National Institutes of Health (NIH) have issued a new training policy: "Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148." Yale University, in compliance with this policy, is requiring investigators and clinical trial site staff who are responsible for the conduct, management, and oversight of NIH-funded as well as industry-sponsored clinical trials to be trained in Good Clinical Practice (GCP). According to the new policy, a GCP refresher course will be required every three years. This policy is effective as of January 1, 2017. The Yale Human Research Protection Program (HRPP) will require investigators and research staff to comply with this policy. If you have not been trained in GCP or have not completed a refresher course in the past three years, you must complete one of the courses listed below by January 1, 2017. ...
Webinar on FDA GCP inspections providing practical information on utilizing quality improvement methods to effectively prepare for FDA GCP inspections.
Examiners should ensure that banking institutions that participate in over-the-counter derivative markets adequately consider the potential liquidity risks associated with the early termination of derivative contracts. Many forms of standardized contracts for derivative transactions allow counterparties to request collateral or to terminate their contracts early if the banking institution experiences an adverse credit event or a deterioration in its financial condition. In addition, under conditions of market stress, customers may ask for the early termination of some contracts within the context of the dealers market making activities. In such situations, a bank that owes money on derivative transactions may be required to deliver collateral or settle a contract early and possibly at a time when the bank may face other funding and liquidity pressures. Early terminations may also open up additional, unintended, market positions. Management and directors should be aware of these potential ...
... or Data andSafety Monitoring Committees (DSMCs)) that may carry out important aspects of clinical trial monitoring. ... Data monitoring committees[edit]. *CHMP/EWP/5872/03: Data monitoring committees[3] (EMA) deals with independent data monitoring ... FDA - Establishment and Operation of Clinical Trial Data Monitoring Committees *^ EMA/CHMP/295050/2013 Adjustment for baseline ... FDA: Establishment and Operation of Clinical Trial Data Monitoring Committees.[4] This guidance discusses the roles, ...
... gives a p-value threshold for each interim analysis which guides the data monitoring committee on whether to stop the trial. ... The Pocock boundary is a method for determining whether to stop a clinical trial prematurely. The typical clinical trial ... The investigators running the clinical trial will wish to stop the trial early for ethical reasons if the treatment group ... The many reasons underlying when to stop a clinical trial for benefit were discussed in his editorial from 2005. The Pocock ...
... regarding the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that three-year loco- ... The FDA has focused its concern on study results from some clinical trials showing an increased risk of death and tumor growth ... In response to these advisories, the FDA released a Public Health Advisory[18] on March 9, 2007, and a clinical alert[19] for ... In a randomized controlled trial,[8] erythropoietin was shown to not change the number of blood transfusions required by ...
"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. CS1 maint: Multiple ... "Home Affairs Committee - Drugs: Breaking the CycleWritten evidence submitted by Sheila M Bird OBE MA PhD CStat FFPH, Medical ... Parmar MKB, Strang J, Choo L, Meade AM, Bird SM (2016). "Randomized controlled pilot trial of naloxone-on-release to prevent ...
... and a national clinical trial comparing ankle replacements against ankle fusion. He is on the Data Monitoring Committee for the ... "BOFAS > About BOFAS > Committees > Outcomes Committee". www.bofas.org.uk. Retrieved 2017-04-10. "Farr Institute , The Farr ... "Clinical Talk". World Scientific Publishing Company. Retrieved 2017-04-10. "New Year Honours List 2011 in full". Telegraph.co. ... He sits on the Outcomes Committee of the British Orthopaedic Foot and Ankle Society (BOFAS) and is leading on several national ...
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 ... Standardization of uveitis nomenclature for reporting clinical data. Results of the first international workshop. Am J ...
Tokai announced the discontinuation of ARMOR3-SV on July 26, 2016, after a data monitoring committee determined that the trial ... In the week following cancellation of the ARMOR3-SV clinical trial, Tokai announced a reduction of its workforce by around 60% ... Galeterone was being compared to enzalutamide in a phase III clinical trial (ARMOR3-SV) for AR-V7-expressing metastatic ... ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2016-02-27. Silberstein, John L.; Taylor, Maritza N.; Antonarakis, Emmanuel ...
"Coronado Biosciences Announces Independent Data Monitoring Committee Recommendation to Discontinue Falk Phase 2 Trial of TSO in ... However these trials (TRUST -I & TRUST -II) failed in Phase 2 clinical trials and were then discontinued after consistent ... Early clinical trials suggested that exposure to helminths such as Trichuris suis or Necator americanus can improve IBD. ... "Coronado Biosciences Announces Top-Line Results From Its TRUST-I Phase 2 Clinical Trial of TSO for the Treatment of Crohn's ...
... 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 ... Amgen sent a "dear doctor" letter in January, 2007, that highlighted results from a recent anemia of cancer trial, and warned ... "ASCO-ASH Clinical Practice Guideline Update on the Use of Epoetin and Darbepoetin in Adult Patients With Cancer". Journal of ...
... of the WHI receiving combined estrogen and progestin therapy was closed prematurely in 2002 by its Data Monitoring Committee ( ... observational studies are as good as or better than randomized clinical trials; animal studies can guide clinical decision- ... The WHI also found a non-significant trend in the estrogen-alone clinical trial towards a reduced risk of breast cancer, though ... Trials[edit]. The Women's Health Initiative trials were conducted between 1991 and 2006 and were the first large, double-blind ...
... regarding the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that three-year loco- ... The FDA has focused its concern on study results from some clinical trials showing an increased risk of death and tumor growth ... In a randomized controlled trial, erythropoietin was shown to not change the number of blood transfusions required by ... Due to the limited clinical benefit and increased risk of retinopathy, early or late erythropoietin treatment is not ...
He has served and continues to serve and on several data monitoring committees of major clinical trials, including Gusto, ECLA ... "Peter Sleight , Clinical Trial Service Unit". ZoomInfo.com. Retrieved 2014-01-08. "Worldwide BioMed Experts - Peter J. Sleight ... 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 has peer reviewed articles and ...
... a number of Independent Data Monitoring Committees for ongoing and completed Phase II/III clinical trials in collaboration with ... This laboratory work has been the rationale for a number of ongoing and completed clinical trials. He was work package leader ... He is involved in a large number of prospective clinical trials in various tumor types, including orphan malignancies, ranging ... Schöffski has a strong background in clinical trial methodology. His Laboratory of Experimental Oncology at KU Leuven has a ...
Clinical trial Good clinical practice (GCP) Data monitoring committees Serious adverse event Adverse effect Adverse drug ... Main article: Monitoring in clinical trials Researchers participating in a clinical trial must report all adverse events to the ... Clinical trial results often report the number of grade 3 and grade 4 adverse events. Grades are defined: Grade 1 Mild AE Grade ... All clinical trials have the potential to produce AEs. AEs are classified as serious or non-serious; expected or unexpected; ...
Clinical trial Ethics committee (European Union) Unethical human experimentation in the United States Informed consent Data ... monitoring committee Declaration of Helsinki Office for Human Research Protections Ethical problems using children in clinical ... 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 ...
... 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 ...
... 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 ...
... 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 ...
Data Interchange Standards Consortium Community-based clinical trial Contract Research Organization Data Monitoring Committees ... Clinical trials registry Academic clinical trials Bioethics CIOMS Guidelines Clinical Trials Clinical data acquisition Clinical ... Each trial record is administered by trial record manager. A trial record manager typically provides initial trial registration ... which mandated the expansion of ClinicalTrials.gov for better tracking of the basic results of clinical trials, requiring: Data ...
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 new type of randomized clinical trial that allows modifications of ongoing trials ... Cytel provides clinical trial design and implementation services and specialized statistical products primarily for the biotech ... Compass Compass is used by biostatisticians and clinicians to plan and design earlier stage adaptive clinical trials ( ...
Oversight of the monitoring activity is the responsibility of the sponsor. Clinical monitoring Data monitoring committee ... Safety monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by ... Inside Clinical Trials Testing Medical Products in People FDA Consumer magazine, September-October 2003 Issue ClinicalTrials. ... Responsibility for data and safety monitoring depends on the phase of the study and may be conducted by sponsor or Contract ...
... 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, ...
"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 ...
Webster MW (July 2011). "Clinical practice and implications of recent diabetes trials". Current Opinion in Cardiology. 26 (4): ... International Expert Committee (July 2009). "International Expert Committee report on the role of the A1C assay in the ... "In Lee M (ed.). Basic Skills in Interpreting Laboratory Data (5th ed.). Bethesda, MD: American Society of Health-System ... or monitored carbohydrate diets such as a low carbohydrate diet.[58][97][98] Viscous fiber supplements may be useful in those ...
... the independent Data Monitoring Committee overseeing the Companys ongoing pivotal Phase 3 clinical trial evaluating Firdapse™ ... recommended that the trial be continued as planned based on the committees review of safety and clinical data from the trial. ... the independent Data Monitoring Committee (DMC) overseeing the Companys ongoing pivotal Phase 3 clinical trial evaluating ... recommended that the trial be continued as planned based on the committees review of safety and clinical data from the trial. ...
Asterias Biotherapeutics Announces Data Monitoring Committee Unanimously Recommends Continuation Of Scistar Phase I/IIa ... Clinical Trial Of AST-OPC1 For Cervical Spinal Cord Injury - read this article along with other careers information, tips and ... biotherapeutics-announces-data-monitoring-committee-unanimously-recommends-continuation-of-scistar-phase-12a-clinical-trial-of- ... Biotherapeutics Announces Data Monitoring Committee Unanimously Recommends Continuation Of Scistar Phase I/IIa Clinical Trial ...
Data Monitoring Committee Unanimously Recommends Continuation Of Combioxin First-In-Human Clinical Trial With CAL02 In Patients ... Combioxin Release: Data Monitoring Committee Unanimously Recommends Continuation Of Combioxin First-In-Human Clinical Trial ... The Independent Data Monitoring Committee has reviewed the safety data from a first set of patients treated with a High Dose of ... that an Independent Data Monitoring Committee has unanimously recommended continuation of the ongoing first-in-human trial in ...
Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition Susan S. Ellenberg, Thomas R. Fleming, ... Statistical Analysis with Missing Data, 3rd Edition Roderick J. A. Little, Donald B. Rubin ...
Randomized clinical trials are increasingly overseen by independent data monitoring committees (DMCs) that monitor trial ... Data and safety monitoring; Data monitoring committee; DMC; Research oversight; Biostatistics; Clinical informatics; Clinical ... Recommendations from the Clinical Trials Transformation Initiatives Data Monitoring Committee Project Presenters. Karim Anton ... The Clinical Trials Transformation Initiative (CTTI) established the Data Monitoring Committees project team to study the roles ...
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 ...
Independent Data Monitoring Committees in Clinical Trials. This course will teach you the statistical display and analysis ... This certificate program covers the skills needed to gather, analyze, and assess data for activities like clinical trials, ... This course teaches you clinical trial designs including randomized controlled trials, ROC curves, CI and tests for relative ... methods used in monitoring clinical trials for safety, as well as the biases and pitfalls inherent in safety review. ...
... to our knowledge this premise has never been tested via a prospective randomized clinical trial. Eligible patients will have ... Before randomization, two clinically-approved radiotherapy plans will be devised for all patients on trial, termed standard and ... This randomized, double-blind trial will comprehensively assess the impact of functional lung avoidance on pulmonary toxicity ... Data safety monitoring committee. The data safety monitoring committee (DSMC) will consist of a statistician, an independent ...
... written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the ... This is the fifth edition of a very successful textbook on clinical trials methodology, ... two specifically on data monitoring. He has served on many NIH and industry-sponsored data monitoring committees for clinical ... and operational responsibilities for many clinical trials in cardiology. He has been on numerous Data Monitoring Committees. He ...
This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have ... two specifically on data monitoring. He has served on many NIH and industry-sponsored data monitoring committees for clinical ... and operational responsibilities for many clinical trials in cardiology. He has been on numerous Data Monitoring Committees. He ... Trial. Dr. Reboussin has served on the Data and Safety Monitoring Boards for many National Institutes of Health trials within ...
Data monitoring committees for pragmatic clinical trials.. Ellenberg SS, Culbertson R, Gillen DL, Goodman S, Schrandt S, Zirkle ... On the Use of Local Assessments for Monitoring Centrally Reviewed Endpoints with Missing Data in Clinical Trials. ... Attitudes toward clinical trials across the Alzheimers disease spectrum.. Nuño MM, Gillen DL, Dosanjh KK, Brook J, Elashoff D ... Flexibly Monitoring Group Sequential Survival Trials When Testing is Based Upon a Weighted Log-Rank Statistic. ...
Has Data Monitoring Committee No. U.S. FDA-regulated Product Not Provided. ... With respect to the latter, the recent Gilead 903 trial has been very informative in the sense that no limb fat wasting ( ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ... Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT ...
Has Data Monitoring Committee Yes U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No. ... The trial is supported by the French program of clinical research and the national health insurance. Two associated studies are ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ... Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT ...
Has Data Monitoring Committee No. U.S. FDA-regulated Product Not Provided. ... Double-blind placebo-controlled trial of fluoxetine in adolescents with comorbid major depression and an alcohol use disorder. ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ... Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT ...
Has Data Monitoring Committee Not Provided. U.S. FDA-regulated Product Not Provided. ... Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT ... A PHASE I TRIAL OF HIGH DOSE CHEMOTHERAPY WITH AUTOLOGOUS BONE MARROW AND PERIPHERAL BLOOD PROGENITOR CELL RESCUE IN PATIENTS ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ...
Has Data Monitoring Committee No U.S. FDA-regulated Product Not Provided ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ... A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia Official Title ICMJE A Randomized Multicenter Trial of Antenatal ... Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT ...
Has Data Monitoring Committee Yes. U.S. FDA-regulated Product Not Provided. ... DESIGN: Prospective, Randomized, Open-label, Single-center trial.. PRIMARY ENDPOINT: Platelet reactivity measured with ... 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 ClinicalTrials.gov Identifier (NCT ...
Has Data Monitoring Committee No. U.S. FDA-regulated Product Not Provided. ... Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT ... This is a multicentre, randomized, open-label parallel trial to demonstrate the superiority and/or non-inferiority of ... Only monitoring data with valid data ,=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic ...
Has Data Monitoring Committee No. U.S. FDA-regulated Product Not Provided. ... the IDEA randomized clinical trial. JAMA. 2013 Sep 25;310(12):1263-73. doi: 10.1001/jama.2013.277669. ... 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 ClinicalTrials.gov Identifier (NCT ...
Has Data Monitoring Committee Yes. U.S. FDA-regulated Product Not Provided. ... NCI-2016-00534 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ). I 270715 ( Other Identifier: Roswell Park ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ... I. To obtain pilot data on clinical response rates using both Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 ...
Has Data Monitoring Committee Yes. U.S. FDA-regulated Product Not Provided. ... The trial is a randomized, prospective double-blind trial in which breastfed infants will receive 200 IU/day or 400 IU/day or ... 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 ClinicalTrials.gov Identifier (NCT ...
Has Data Monitoring Committee Yes. U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes. ... Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT ... trial. Circ Res. 2014 Apr 11;114(8):1302-10. doi: 10.1161/CIRCRESAHA.114.303180. Epub 2014 Feb 24.. ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ...
Has Data Monitoring Committee Yes. U.S. FDA-regulated Product Not Provided. ... A recently completed randomized clinical trial, the Convergence Insufficiency Treatment Trial (CITT), demonstrated that a 12- ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ... A prospective clinical trial is therefore needed to determine the effectiveness of home-based computer therapy for symptomatic ...
Has Data Monitoring Committee Yes. U.S. FDA-regulated Product Not Provided. ... Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT ... Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ...
Has Data Monitoring Committee No. U.S. FDA-regulated Product Not Provided. ... there is a paucity of clinical trials comparing these two surgical techniques with regards to clinical and functional outcomes ... there is a paucity of clinical trials comparing these two surgical techniques with regards to clinical and functional outcomes ... ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP ...
  • He joined the staff of the university and hospital and rose rapidly through the ranks to full professorship in pediatrics, pharmacology and medicine, won a Career Scientist Award from the Ontario Ministry of Health and established an international reputation as an expert in the field of clinical pharmacology and toxicology. (wikipedia.org)
  • The Clinical Performance Tool, with 21 individual items, designed for evaluation of Pediatric Advanced Life Support scenarios, was utilized to assess clinical performance of the team. (clinicaltrials.gov)
  • Assess the quality of the data by judging it against criteria identified at the first stage. (wikipedia.org)
  • While at the NIH and subsequently, he served as a consultant on clinical trials to various NIH institutes and to other governmental and nongovernmental organizations. (springer.com)
  • Subsequently, with his UCSF colleagues in surgery, he helped launch the UCSF liver transplant program, which remains one of largest and most successful programs nationally and internationally As a member of the Training and Workforce Committee of the American Association for the Study of Liver Diseases, he worked with his colleagues to set current standards for training in hepatology. (wikipedia.org)
  • In 2012, Catalyst licensed Firdapse™ from BioMarin and Catalyst assumed management of the Phase 3 pivotal trial, initiated by BioMarin. (cnbc.com)
  • Cytori's lead indication is currently in a US phase III, FDA approved, pivotal study, the STAR TRIAL (ClinicalTrials.gov Identifier: NCT02396238), designed to evaluate one administration of Cytori's ECCS-50 in treating impaired hand and finger function from scleroderma. (wikipedia.org)
  • FDA: Clinical trial endpoints for the approval of cancer drugs and biologics provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications. (wikipedia.org)
  • Only 10 percent of all drugs started in human clinical trials become an approved drug. (wikipedia.org)
  • People over 55 (or a similar cutoff age) are often excluded from trials because their greater health issues and drug use complicate data interpretation, and because they have different physiological capacity than younger people. (wikipedia.org)
  • Clinical monitoring Data monitoring committee European Medicines Agency Serious adverse event (SAE) U.S. Food and Drug Administration (FDA) Ariel E. Quinio, Safety in Clinical Trials: Who is Responsible? (wikipedia.org)
  • The FDA did not withdraw the drug from the market because its clinical benefits outweigh the risks involved. (wikipedia.org)
  • Pharmacokinetic data are important for determining the optimal dose or schedule of a drug. (wikipedia.org)
  • Medivir has a cathepsin K inhibitor, MIV-711 (L-006235), in Phase IIa clinical trial, as a disease modifying osteoarthritis drug, as of October 2017. (wikipedia.org)
  • Operate post-marketing surveillance for reporting, investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices. (wikipedia.org)
  • The MHRA has been criticised by the House of Commons Health Committee for, among other things, lacking transparency, and for inadequately checking drug licensing data. (wikipedia.org)
  • Allan Coukell, director of drugs and medical devices at The Pew Charitable Trusts, testified in front of the House Committee, in a statement published by Reuters, that "By allowing drug developers to rely on smaller datasets, and clarifying FDA's authority to tolerate a higher level of uncertainty for these drugs when making a risk/benefit calculation, ADAPT would make the clinical trials more feasible. (wikipedia.org)
  • As a member of the data safety monitoring board for a study of the anti-prostate cancer effects of abiraterone acetate (Zytiga), she argued that stopping the study early had prevented the study from accurately determining the effectiveness of the drug, and possibly made it appear to be more effective than it actually was. (wikipedia.org)
  • In clinical trials, the most common side effect was headache, experienced by about 18% of drug arm participants compared to 11% of placebo participants. (wikipedia.org)
  • In their 9-5 vote, the committee raised concerns about the safety of the drug, particularly the findings of tumors in rats. (wikipedia.org)
  • On 23 October 2010, the FDA decided not to approve the drug based on the available data. (wikipedia.org)
  • The FDA stated that the weight loss data passed FDA standards for efficacy and that the drug did not have cancer risks based on clarifications in the data. (wikipedia.org)
  • There are numerous variables that influence the interpretation of drug concentration data: time, route and dose of drug given, time of blood sampling, handling and storage conditions, precision and accuracy of the analytical method, validity of pharmacokinetic models and assumptions, co-medications and clinical status of the patient. (wikipedia.org)
  • Many different professionals (physicians, clinical pharmacologists, clinical pharmacists, nurses, medical laboratory scientists, etc.) are involved with the various elements of drug concentration monitoring, which is a truly multidisciplinary process. (wikipedia.org)
  • The drug dose cannot be optimised by clinical observation alone. (wikipedia.org)
  • The 2008 meta-analysis combined 35 clinical trials submitted to the Food and Drug Administration (FDA) before licensing of four newer antidepressants (including the SSRIs paroxetine and fluoxetine, the non-SSRI antidepressant nefazodone, and the serotonin and norepinephrine reuptake inhibitor (SNRI) venlafaxine). (wikipedia.org)
  • Nobel prize-winning economist Gary S. Becker has argued that FDA-required clinical trials for new drugs do contribute to high drug prices for consumers, mainly because of patent protection that provides a temporary monopoly which disallows cheaper alternatives from entering the market. (wikipedia.org)
  • In 2010, prescription drug expenses were 10% of the $2.6 trillion of total health care spending in the US, and its third largest portion after hospital spending and physician and clinical services. (wikipedia.org)
  • In 2003, data from the Medical Expenditure Panel Survey showed that only 9.5% of Americans with Medicare coverage had no prescription drug expenses, while 61.6% had prescription drug expenses up to $2,083, and 28.9% of those on Medicare had expenses higher than $2,084. (wikipedia.org)
  • The design of a clinical trial will depend on the drug and the phase of its development. (wikipedia.org)
  • Efficacy is the extent to which a drug works under ideal circumstances, i.e., in clinical trials. (wikipedia.org)
  • It highlights the key issues involved when sponsors include data monitoring committees as a part of their trial management. (wikipedia.org)
  • Other key capabilities include R code integration, trial simulation compute engines, plus various tables, charts and graphs to visualize and communicate trial design attributes. (wikipedia.org)
  • Cautions include: Myelosuppression Tumour lysis syndrome Liver impairment History of pancreatitis Check serum lipase periodically in order to detect pancreatitis Total gastrectomy Avoid pregnancy or impregnating women Dose reduction of nilotinib has been recommended in hepatically impaired population which involves recommendation of lower starting dose and monitoring of any hepatic function abnormalities. (wikipedia.org)
  • Most clinical trial portals include a secure document exchange technology that facilitates the negotiation of these grants as well as an application that tracks the processing of each grant. (wikipedia.org)
  • Clinical Trial Portals may include an LMS (Learning Management System) to deliver and track on and offline training and certification. (wikipedia.org)
  • Clinical Trial Portals can include patient recruitment management applications that track actual vs projected enrollment, site recruitment plans, IRB/EC submission/approval dates, recruitment material management, outreach tactics and ROI. (wikipedia.org)
  • In adults, long-term EEG monitoring typically involves one of three procedures which include long-term video-EEG monitoring, sleep-deprived EEG monitoring, and 24-hour ambulatory monitoring. (wikipedia.org)
  • Boards include Consumer Union (1982-1987), Board on Mathematic Sciences and their Applications/National Academy of Sciences, and the National Committee for Quality Assurance (NCQA) (1992-1998). (wikipedia.org)
  • Plans may collect data for this measure by reviewing insurance claims or automated immunization records, but this method will not include immunizations received at community clinics that do not submit insurance claims. (wikipedia.org)
  • The organization is sometimes referred to by other names that include some or all of the words: Workgroup for Electronic Data Interchange. (wikipedia.org)
  • In addition, he is the Robert and Harriet Heilbrunn Professor of Medicine at The Mount Sinai School of Medicine as well as Director of Clinical Cardiology in the Zena and Michael A. Wierner Cardiovascular Institute at The Mount Sinai Medical Center, both in New York City. (wikipedia.org)
  • The data published by the WHI suggested supplemental estrogen increased risk of venous emboli and breast cancer but was protective against osteoporosis and colorectal cancer, while the impact on cardiovascular disease was mixed. (wikipedia.org)
  • New measures in HEDIS 2013 are "Asthma Medication Ratio," "Diabetes Screening for People With Schizophrenia and Bipolar Disorder Who Are Using Antipsychotic Medications," "Diabetes Monitoring for People With Diabetes and Schizophrenia," "Cardiovascular Monitoring for People With Cardiovascular Disease and Schizophrenia," and "Adherence to Antipsychotic Medications for Individuals With Schizophrenia. (wikipedia.org)
  • Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston as: Trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH). (wikipedia.org)
  • These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines. (wikipedia.org)
  • A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH (The International Council for Harmonisation) and GCP guidelines in the US and Europe. (wikipedia.org)
  • In the United Kingdom, the NICE guidelines recommend using a clinical prediction rule for this purpose. (wikipedia.org)
  • Asterias expects to report additional efficacy and safety data for Cohort 2, as well as for the currently-enrolling Cohorts 3 and 4, later this year. (biospace.com)
  • The program seeks to promote appraisal of evidence in terms of proven efficacy and safety from controlled clinical trial data, and adequate consideration of quality, cost and choice of competitor drugs by choosing the item that has been most thoroughly investigated, has favorable pharmacokinetic properties and is reliably produced locally. (wikipedia.org)
  • If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. (clinicaltrials.gov)
  • This course will teach you how to use various cluster analysis methods to identify possible clusters in multivariate data. (statistics.com)
  • This course will introduce you to the essential techniques of text mining as the extension of data mining's standard predictive methods to unstructured text. (statistics.com)
  • Company founders Cyrus Mehta, Ph.D. and Nitin Patel, Ph.D. are amongst the pioneering statisticians credited for developing the underlying statistical methods behind so-called "flexible" designs: group sequential and adaptive trials. (wikipedia.org)
  • Compass is the first commercially offered adaptive trial composition software with both frequentist and Bayesian methods. (wikipedia.org)
  • Although radium does not easily form stable molecular complexes, there has been presented data on methods to increase and customize its specificity for particular cancers by linking it to monoclonal antibodies, by enclosing the 223Ra in liposomes bearing the antibodies on their surface. (wikipedia.org)
  • Pre-trial registration makes non-publication and changes in analysis methods obvious to medical reviewers. (wikipedia.org)
  • Analyse and combine the data (using complex statistical methods) which give an overall result from all of the data. (wikipedia.org)
  • The DMC is comprised of an independent group of medical and scientific experts and is responsible for reviewing and evaluating patient safety and efficacy data for safeguarding the interest of study participants. (biospace.com)
  • Galeterone was being compared to enzalutamide in a phase III clinical trial (ARMOR3-SV) for AR-V7-expressing metastatic castration-resistant prostate cancer. (wikipedia.org)
  • According to the NIH National Cancer Institute there are currently 39 active clinical trials testing palbociclib on its own or in combination with other medications. (wikipedia.org)
  • Fish oil and omega-3 fatty acids have been studied in a wide variety of other conditions, such as clinical depression, anxiety, cancer, and macular degeneration, yet benefits in these conditions have not been verified. (wikipedia.org)
  • A priori TDM consists of determining the initial dose regimen to be given to a patient, based on clinical endpoint and established on population [(PK/PD) ]relationships. (wikipedia.org)