Admin - See
- NIH-Defined Phase III Clinical Trial
-
An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.
Quoted from the NIH OER Glossary & Acronym List.
The FDA definition of Phase III clinical trials focuses primarily on a clinical investigation of drugs, vaccines, biologics, and devices. Clinical trials of experimental drugs covered in the FDA definition proceed through four phases (21 CFR Section 312.21).
For additional information regarding the FDA definitions of the different phases of clinical trials, visit the ClinicalTrials.gov website.
- See Also: Clinical Trial