clinical trial

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 [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

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 United States Pharmacopiea (USP) is an organization that primarily focused on pharmaceutical testing until the rise of dietary supplements.
About 70 animal rights activists defied pleas from farmers and police and travelled from all over Britain to protest outside controversial Huntingdon Life Sciences pharmaceutical testing laboratory in Huntingdon, Cambs.
In addition to housing the company's worldwide corporate offices, the 185,000 square-foot facility houses the world's premier bioanalytical laboratory dedicated to pharmaceutical testing, a 210-bed clinical research centre and a full spectrum of drug development services, from discovery through drug registration services.
Examples of such chimeras might include pigs growing human organs for transplants or chimpanzee-human chimeras to be used for pharmaceutical testing.
Commenting on the new facility, Alison Clayton -- general manager at Eurofins BioPharma Product Testing - said it will allow the company to "provide a range of GMP pharmaceutical testing services, including method development and validation, finished product and raw material testing, elemental impurity testing, micro testing and stability studies.
a leading Quebec-based full-service pharmaceutical testing laboratory, announces its expansion into the United States this morning with the strategic acquisition of Averica Discovery Services Inc.
PPD will provide project management, technical expertise, strategic planning market analysis and training along with pharmaceutical testing assay validation, validated storage and shipment, nonclinical testing and clinical development study support, integrated logistics, equipment maintenance, information technology and other capabilities.
Moreover, 3D cell culture's ability to replace the animal in research and pharmaceutical testing is also driving the growth of the market.
Even if the researcher's intent is not to formulate or receullurize a brand new organ using a 3-D printer, simply printing stem cells into groups can aid in the pharmaceutical testing process as well.
Food and pharmaceutical testing specialist ILS (International Laboratory Services) says its plans to return to full operations following the recent fire at its facility in Shardlow, Derbyshire are well advanced and progressing to schedule.
Pharmaceutical testing requires a high degree of knowledge.

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