clinical trial

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Related to Clinical studies: Clinical research, phase 1 clinical trial, preclinical studies


 [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.

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 ?
We have completed post-marketing human clinical studies of CORTOSS in Europe for its use in hip compression screw augmentation.
We are conducting clinical studies of RHAKOSS in Europe required to obtain a CE Mark for its use as an interbody fusion device.
There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products.
These early results in our current Phase I/II clinical studies are an important step forward, but because they are preliminary, we will need to complete additional clinical studies with larger numbers of patients to demonstrate efficacy and establish the roles of I-Mel- 1 and I-Mel-2 in the management of melanoma," said Dr.
Data from six clinical studies, which further establish the safety and efficacy of the Pillar Procedure, were presented by several of the foremost otolaryngologists from the U.
Among other things, the University of Washington's intention to use the animal test results to apply for the Investigational Device Exemption for FDA clinical studies contain forward-looking statements.
In addition, readers are cautioned that results from preclinical studies and early-stage clinical studies of bevirimat may not be replicated in larger, later-stage clinical studies of that product candidate.
Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of REMUNE(R), the Company's first generation HIV product candidate.
Based on the established biology of rhPDGF as a wound healing factor and the demonstrated clinical benefit of the combination of rhPDGF and B-TCP to stimulate new bone formation, as shown in the Company's clinical studies with their product GEM 21S(R), I am optimistic about the potential for GEM OS1 to accelerate healing in foot and ankle applications," said Christopher W.

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