clinical trial

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trial

 [tri´al, trīl]
a test or experiment.
clinical trial an experiment performed on human beings in order to evaluate the comparative efficacy of two or more therapies. See also single blind, double blind, and triple blind.

clinical trial

a controlled experiment involving a defined set of human subjects, having a clinical event as an outcome measure, and intended to yield scientifically valid information about the efficacy or safety of a drug, vaccine, diagnostic test, surgical procedure, or other form of medical intervention.

Four phases of clinical trial are distinguished. Phase I trials usually involve fewer than 100 healthy volunteers who are exposed to a new drug or procedure. Such studies seek to establish optimal dosage and route of administration and to detect adverse reactions. Phase II trials generally involve 200-500 volunteers randomly assigned to control and study groups. These are pilot efficacy studies, with emphasis on immunogenicity in the case of vaccines, and on relative efficacy and safety in the case of drugs, procedures, and devices. Phase III trials, often multicenter, involve thousands of volunteers, randomly assigned to control and study groups. The aim is to generate statistically relevant data. Phase IV trials are conducted after a national drug registration authority (in the U.S., the Food and Drug Administration) has approved an agent for distribution or sale. They may explore specific pharmacologic effects, adverse reactions, or long-term effects.

clinical trial

n.
A research study using consenting human subjects that tests the effectiveness and safety of a treatment, a diagnostic tool, or a prophylactic intervention.

clinical trial

A research study involving human subjects designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device), or new ways of using a known drug, treatment or device.

clinical trial

Clinical medical trial, clinical research trial Research A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or behavioral interventions. See Drug discovery, IND, Phase I, II, and III studies.

clin·i·cal trial

(klini-kăl trīăl)
A controlled experiment involving a defined set of human subjects, having a clinical event as an outcome measure, and intended to yield scientifically valid information about the efficacy or safety of a drug, vaccine, diagnostic test, surgical procedure, or other form of medical intervention.

clinical trial

a scientifically controlled study under specific conditions, to test, for example, the effectiveness of a drug/ treatment.

Clinical trial

All new drugs undergo clinical trials before approval. Clinical trials are carefully conducted tests in which effectiveness and side effects are studied, with the placebo effect eliminated.

trial, randomized controlled (RCT) 

An experimental design used for testing the effectiveness of a new medication or a new therapeutic procedure. Individuals are assigned randomly to a treatment group (experimental therapy) and a control group (placebo or standard therapy) and the outcomes are compared. The trial is strengthened by 'blinding' or masking (single-blind, double-blind or triple-blind study) and cross-over design. RCT is the most accepted scientific method of determining the benefit of a drug or a therapeutic procedure. It represents the best evidence available, which is integrated into the final decision about the management of a condition by healthcare practitioners in what is called evidence-based healthcare. Syn. randomized clinical trial. See sampling; significance; study.
References in periodicals archive ?
The frontrunners--cellulose sulfate, Savvy, PRO 2000 and BufferGel--are all slated to undergo phase III trials in 2003.
M2 EQUITYBITES-May 14, 2018-AstraZeneca provides update on the GALATHEA phase III trial of Fasenra
Faron has also recently received the second IDMC (Independent Data Monitoring Committee) recommendation to continue the INTEREST pan-European Phase III trial with Traumakine without any modifications.
Results from all Phase III trials are due to be reported by the first half of 2012.
The Phase III trial titled Pexelizumab for Reduction of Infarction and Mortality in Coronary Artery Bypass Graft Surgery 2 (PRIMO-CABG2), included approximately 4,250 patients, and compared the safety and efficacy of pexelizumab against that of placebo in reducing heart attack and death following CABG surgery with or without concomitant valve surgery.
Requirements prior to Phase III studies include product manufacturing, an end-of-Phase II meeting with the FDA, and the design of Phase III trials. It is expected that final decisions about the size, duration, and other attributes of future studies will be made in conjunction with a licensing partner and/or upon meeting with the FDA.
One issue that there appears to be universal agreement on is the importance of participation in clinical trials, specifically randomized phase III trials. In fact, it was the promising results of phase II trials, which frequently reported results in comparison to historical controls, which prompted randomized trials.
Atogepant appears to be effective in preventing migraines for episodic patients and while the incidence of elevated liver enzymes was balanced between the arms, it is a risk that needs to be studied in larger and longer Phase III trials, Van Buren tells investors in a research note.
GALATHEA and TERRANOVA are randomised, double-blinded, 56-week placebo-controlled, multi-centre Phase III trials assessing the safety and efficacy of Fasenra as an add-on to dual or triple inhaled therapy in comparison to placebo.
The initiation of the Japanese study indicates that the Pan-European and Japanese Phase III trials combined aim to treat maximum 420 moderate to severe acute respiratory distress syndrome patients, with results likely to be available in 2017-2018.
Sobi is currently recruiting patients for the phase III trials with its hemophilia drugs rFVIIIFc (Hemophilia A) and rFIXFc (Hemophilia B), developed in cooperation with US partner Biogen Idec Inc (NASDAQ: BIIB).
Specifically, one subject in the phase III trials experienced elevated liver enzymes (AST, ALT) and total bilirubin.