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clinical trial definition: controlled study designed to assess the safety and efficacy of new drugs, devices, treatments, or preventive measures in humans by comparing two or more interventions or regimens; prefer specific phase NTs.
Clinical Trials as Topic definition: 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.
Clinical Trial definition: A research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, and preventive care.
Clinical Trial definition: A type of research study that tests how well new medical treatments or other interventions work in people. Such studies test new methods of screening, prevention, diagnosis, or treatment of a disease. The study may be carried out in a clinic or other medical facility.
Controlled Clinical Trials as Topic definition: 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.
Trial of Labor definition: Allowing a woman to be in LABOR, OBSTETRIC long enough to determine if vaginal birth may be anticipated.
CROSSOVER TRIAL definition: A method of comparing two or more treatments or interventions in which subjects or patients, upon completion of the course of one treatment, are switched to another. Typically, allocation to the first treatment is by random process. Participants' performance in one period is used to judge their performance in others, usually reducing variability.
Cross-Over Studies definition: 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)
NONRANDOMIZED CONTROL TRIALS definition: Experiment in which assignment of patients to the intervention groups is at the convenience of the investigator or according to a pre-set plan that does not conform to the definition of RANDOM.
randomized clinical trial definition: A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
Randomized Controlled Clinical Trial definition: A study in which the participants are assigned by chance to separate groups to evaluate treatments. The study also includes a control group, which is undergoing the same rigors of the study with placebo treatment or standard treatment. The trial can also be controlled by the addition of a test group to ensure there are no factors present to skew the results and by the inclusion of peer-review analysis by appropriate government officials. 2005
Randomized Controlled Trials as Topic definition: 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.
phase II trial definition: A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.
Phase II Trial definition: Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary)
Clinical Trials, Phase II as Topic definition: 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.
clinical trial phase II definition: in Phase II clinical trials, the study drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase II Trial definition: A clinical research protocol designed to study a biomedical or behavioral intervention in a larger group of people (several hundred), to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the intervention.
phase III trial definition: A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.
Phase III Trial definition: Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary)
Clinical Trials, Phase III as Topic definition: 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.
clinical trial phase III definition: in Phase III studies, the study drug or treatment is given usually to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase III Trial definition: A clinical research protocol designed to investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand), to confirm efficacy, to monitor adverse reactions to the new medication or treatment regimen with respect to long-term use and by comparing the intervention to other standard or experimental interventions as well as to a placebo.
phase IV trial definition: After a treatment has been approved and is being marketed, it is studied in a phase IV trial to evaluate side effects that were not apparent in the phase III trial. Thousands of people are involved in a phase IV trial.
Phase IV Trial definition: Phase 4. Postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [After FDA CDER Handbook, ICH E8] (CDISC glossary)
Clinical Trials, Phase IV as Topic definition: 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.
clinical trial phase IV definition: phase IV studies are done after the drug or treatment has been marketed; studies continue testing the study drug or treatment to collect information about its effect in various populations and any side effects associated with long term use.
Phase IV Trial definition: A randomized, controlled trial that is designed to evaluate the long-term safety and efficacy of a drug for a given indication. Often they are designed to study side effects that may have become apparent after the phase III study was completed.
phase I trial definition: The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of the treatments being tested, phase I trials usually include only a small number of patients who have not been helped by other treatments.
Phase I Trial definition: The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase I studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [After FDA CDER Handbook, ICH E8] (CDISC glossary)
Clinical Trials, Phase I as Topic definition: 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.
clinical trial phase I definition: in Phase I clinical trials, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase I Trial definition: A clinical research protocol designed to test a new biomedical intervention in a small group of people for the first time. A Phase I trial can be to establish the toxicity of a new treatment with escalating intensity of the treatment administered and/or to determine the side effects of a new treatment for a particular indication in subjects.
Clinical Trials Data Monitoring Committees definition: 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.
Adjuvant Study definition: A study performed secondary to and in support of a primary or base study in order to support, enhance, or expand upon its results or findings.
diagnostic trial definition: A research study that evaluates methods of detecting disease.
Diagnostic Trial definition: Clinical evaluation of the utility of diagnostic procedures.
Preparation for Vaccine Efficacy Trials definition: Identify appropriate domestic and international populations and develop infrastructure and collaborations with government, communities, and industry necessary for ensuring adequate performance of efficacy trials.
Quick Trials Program definition: Promises to speed the translation of ideas developed in the laboratory to early stage clinical trials by simplifying the grant application process and providing a rapid turnaround from application to funding.
Therapeutic Clinical Trial definition: A clinical study that involves administering of exposure to the agent/agents to subjects with particular disease to elucidate the most appropriate treatment for a specific medical condition, or to prolong or improve the patient's life.
AIDS, Clinical Trials on Minorities definition: AIDS clinical trials related to individuals of non-Caucasian descent.
AIDS, Clinical Trials on Children definition: AIDS clinical trials related to children 0-18 years of age. These trials include pregnant females, neonates, and infants.
AIDS, Clinical Trials on Women definition: AIDS clinical trials related to females 12 years of age or older. These trials include pregnant women, women at risk of AIDS, female prostitutes, and women who have perinatally transmitted AIDS to a fetus or newborn.
Cancer Clinical Trials Education Program definition: The Cancer Clinical Trials Education Program provides training to nurses and social workers to educate patients and their families about clinical trials. (Bypass Budget 2002)
Cancer Prevention Trial definition: Clinical trials that study ways of reducing the risk of getting cancer.
Cancer Trials Support Unit definition: Streamlines and centralizes administrative, financial, and data collection tasks. The submission and development of ideas for protocols are made easier through electronic forms, templates, and databases.
Clinical Trials Design definition: The detailed planning of 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.
Clinical Trial Eligibility Criteria definition: Characteristics which are necessary to allow a subject to participate in a clinical study, as outlined in the study protocol. The concept covers inclusion and exclusion criteria.
Adjunct Clinical Trial definition: A grant that uses materials from some other clinical trial.
Clinical Trials Database definition: Mandated by the FDA Modernization Act of 1997. An NIH-wide database of information about federally and privately funded clinical trials regarding serious or life-threatening diseases or conditions.
Clinical Trials Informatics System definition: The Clinical Trials Information Management System is an effort to develop an integrated system for managing various aspects of a clinical trial. The overall goal of the project is to create an integrated tool to support all aspects of a clinical trial, including Protocol development/submission, Administration, Patient Management, and Data Collections and Acquisitions.
monitoring definition: The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [ICH E6 Glossary]
Clinical Trials, Monitoring definition: For clinical decision-making, the purposeful and ongoing acquisition, interpretation, and synthesis of patient data obtained from clinical trials.
Clinical Trial, Other definition: A clinical trial that is not therapeutic, preventive or diagnostic.
Conduct Clinical Trials definition: Conduct clinical trials and develop new trial methodologies. Trials should be designed in order to rapidly develop new therapeutic strategies, optimize clinical efficacy and proper use of available modalities, define factors that affect the success of therapeutic strategies (including the role of resistance), and advance our understanding of disease pathogenesis and progression.
cooperative group definition: A group of physicians, hospitals, or both formed to treat a large number of persons in the same way so that a new treatment can be evaluated quickly. Clinical trials of new cancer treatments often require many more people than a single physician or hospital can care for.
Microdosing Trials, Human definition: Use of doses at only 1% of the pharmacological dose in humans in order to evaluate the pharmacokinetics. Such trials are sometimes referred to as phase zero trials.
Compassionate Use Trials definition: Providing an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available. Compassionate use trials allow patients to receive promising but not yet fully studied or approved therapies when no other treatment option exists. Also called expanded access trial.
Early Termination of Clinical Trials definition: Earlier than planned termination of clinical trials.