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 ?
There can be no guarantee that the clinical trials described in this release will be successful.
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.
This press release contains express or implied forward-looking statements relating to, among other things, the performance of Phase Forward's products and services, the ability of Phase Forward's customers to realize benefits from the use of Phase Forward's products and services, and regulatory requirements applicable to clinical trials and drug safety.
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The advocates ask: Why shouldn't payers fund clinical trials where at least there is some assurance that the patient is being treated with a scientifically based treatment option?
Genentech and Curis expect to have final results from the Phase I clinical trial during the first half of 2006.
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SB-743921 entered a Phase I clinical trial conducted by GSK in the United States in May 2004 to evaluate its tolerability and pharmacokinetics in advanced cancer patients.
GlobalData's clinical trial report, "Arterial Thrombosis Global Clinical Trials Review, H2, 2014" provides data on the Arterial Thrombosis clinical trial scenario.
Drug Candidate Demonstrates Sufficient Anti-Tumor Activity to Proceed in Its Phase II Locally Advanced or Metastatic Breast Cancer Clinical Trial
Summary GlobalData's clinical trial report, "Arterial Calcification Global Clinical Trials Review, H2, 2014" provides data on the Arterial Calcification clinical trial scenario.
SEATTLE -- Advanced Clinical Software (ACS), the leader in clinical trial management software (CTMS), announced today that Baylor College of Medicine (BCM) has chosen ACS' Study Manager software as their end-to-end solution for managing clinical trials.

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