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Monday, December 11, 2023 7:11:29 PM
>>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.
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