clinical trial


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Related to clinical trial: Randomized clinical trial, Clinical research

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.

clinical trial,

n a trial based upon the scientific method in which a control group and a test group are compared over time in order to study a single, differing factor.
References in periodicals archive ?
All of these resources are devoted solely to conducting clinical trials.
For clinical trials at this stage, statistically relevant numbers of participants are essential, so they are often conducted at a number of different sites.
Clinical Trial Overview of Psyadon Pharmaceuticals, Inc.
Participation in clinical trials essentially requires three Ingredients: (1) physicians willing to refer patients to clinical trials: (2) patients willing to participate and accept the uncertainty of randomization: and (3) a mechanism to pay for the therapy.
Many payers might be more receptive to funding clinical trials if the diffusion of investigational therapies could be restricted until adequate outcomes data could be collected.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Global Clinical Trials Review, Q1, 2011
These advancements include identification of a new tablet formulation for XP19986 that may be suitable as a once-a-day treatment for gastroesophageal reflux disease, or GERD, as well as updates on clinical trials that are part of XenoPort's XP13512 development program.
Consistent with earlier trials, this clinical trial demonstrated again that SILENOR[TM] was well tolerated.
The company expects results from its remaining Phase 3 clinical trial for SILENOR[TM] in December of this year.
A 2006 Bio-IT World Life Sciences Conference and Expo "Best of Show" winner, the CTSD system provides a library of predefined and customizable tests that tailor signal detection algorithms to the unique requirements of clinical trial data.
In addition, clinical trials using cortical stimulation for the treatment of severe tinnitus and treatment-resistant depression continue to progress.
Kendle will support CVBT in its Phase II clinical trial ensuring that the protocol and study adhere to FDA regulatory requirements.

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