clinical trial


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Related to clinical trial: Randomized clinical trial, Clinical research
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Noun1.clinical trial - a rigorously controlled test of a new drug or a new invasive medical device on human subjects; in the United States it is conducted under the direction of the FDA before being made available for general clinical use
trial, run, test - the act of testing something; "in the experimental trials the amount of carbon was measured separately"; "he called each flip of the coin a new trial"
phase I, phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
phase II, phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase III, phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA
phase IV, phase IV clinical trial - sometimes the FDA approves a drug for general use but requires the manufacturer to continue to monitor its effects; during this phase the drug may be tried on slightly different patient populations than those studied in earlier trials
References in periodicals archive ?
Virulizin(R) is currently the subject of a fully enrolled global Phase III registration clinical trial for the treatment of advanced pancreatic cancer in combination with gemcitabine.
The CRO physician may co-author a peer-reviewed journal article after overseeing a particularly significant clinical trial or provide comment on behalf of the CRO to a government agency on a proposed regulation or policy affecting the drug development and approval process.
First, data must be collected that suggest that a new treatment may be useful in MS - this is the "scientific rationale" for a clinical trial.
Using Acurian's proprietary, Web-enabled databases and clinical trial launch applications, bio-pharmaceutical companies can quickly recruit and select the most qualified physicians and patients for specific clinical trials and facilitate the required regulatory documents.
For example, in the early recruitment period for the clinical trials, it was estimated that less than 1 percent of patients with metastatic breast cancer who received an ABMT did so within the context of a randomized clinical trial.
For example, in a Phase III clinical trial, there is theoretically adequate evidence that the "investigational" arm of the treatment performs as least as well, and hopefully better, than the standard, control therapy.

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