clinical trial
Glossaries
| Term | Definition |
|---|---|
| clinical trial |
A research investigation involving human subjects that is 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). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [After ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation, randomized controlled trial (RCT).
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Synonyms:
Interventional Clinical Trial; Interventional Study |
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