What are the details for inclusion in NIH-defined Phase III clinical trials?
Applications/Proposals for an NIH-defined Phase III clinical trial require a review of evidence to show whether or not clinically important sex/gender and race/ethnicity differences in the intervention effect are to be expected. This evidence may include, but is not limited to, data derived from prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology studies, and observational, natural history, epidemiology and other relevant studies. Based on prior studies, investigators must decide which of the following three situations apply to their proposed clinical trial.
