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.

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 ?
According to UK Sport, the drug testers were repeatedly assured the player was on his way, and more than once club officials went off to look for him.
In France, drug testers take an oath before a court to discharge their duties honestly before they are allowed to work.
Drug testers normally make known to players and managers at half-time who they intend to test after the game and the identification of the players is supposed to be kept confidential.
We had the drug testers at the game, but they should not be going in to see the players, they should be going in to see the officials.
Local man Gerald Middle said: ``The drug testers are supposed to give 24 hours' notice and didn't on this occasion.
He told reporters at his victory news conference: "I knew snowboarding was getting big when drug testers started turning up at races.
Three British athletes have already picked up bans for not being around on three occasions when drug testers called.
Those include Ferdinand's insistence that he simply forgot to give a sample when drug testers arrived at United's Carrington training ground.
I have never ever been at a club where the drug testers leave you to your own devices.
The FA's prosecution relies almost exclusively on the UK Sport drug testers, who attended United's Carrington training ground on September 23 and left without Ferdinand giving a sample.
One day a few years ago the drug testers arrived at Melwood when everyone was out so they tested the injured lads instead.
UK Sport's anti-doping system demands that athletes tell the drug testers where they will be for one hour a day on five days out of seven.