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 ?
A subcutaneous formulation of ofatumumab is also being investigated in two phase III clinical studies in relapsing multiple sclerosis.
"Both in the Phase III and later in the Phase IV, the frequency in all lines will be better as we are going to use a better signaling system.
One composter/grower farm had three Phase II tunnels, nine Phase III tunnels and 24 Dutch-type growing rooms.
On August 10, 2006, Advancis announced that the company's Phase III trial for the treatment of acute pharyngitis/tonsillitis in adults and adolescents due to Group A streptococcal infections successfully met its primary and secondary endpoints.
The Daily said Guangzhou officials estimate that the required installation of OBD systems under the State Phase III standards will increase the cost of a new vehicle by approximately $125.
The river's edge in Phase III of Riverside Park South was engineered to foster diverse ecologies and habitats.
Once again, assuming the drug shows sufficient evidence of efficacy and no major safety concerns--whether purely from drug effect, or from drug-drug interactions--a go/no go decision will be made to proceed to Phase III.
AnorMED, Inc., Vancouver, British Columbia, announced it has begun enrolling patients into its Phase III clinical program for AMD3100, a stem cell mobilizer and potential new agent in stem cell transplantation for cancer patients.
Phase III trials (20,000 participants) will determine the efficacy of the HPV L1 VLP vaccine by using prevention of type-related CIN I, genital warts, and CIN II/III as the endpoints.
Avineon, Inc., an information technology solutions provider, has announced that it has been awarded a Small Business Innovation Research (SBIR) Program Phase III contract by the U.S.
Phase III is used to determine more specific customer satisfaction.