Clayton State University IRB

Question 5: Does your proposed research meet criteria for an 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 either evaluating an experimental intervention in comparison with a standard or control intervention or of 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.

If your research meets the above criteria, then in addition to providing a Data and Safety Monitoring Plan, you will be expected to address whether you expect to find clinically important sex/gender and/or race/ethnicity differences in the intervention effect. The discussion may include supporting evidence and/or data derived from prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology studies, and observational, natural history, epidemiology, and other relevant studies.

You will be expected to provide a research plan that must include one of the following plans:

• Plans to conduct valid analyses to detect significant differences in intervention effect among sex/gender and/or racial/ethnic subgroups when prior studies strongly support these significant differences among subgroups, OR
• Plans to include and analyze sex/gender and/or racial/ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups. (Representation of sex/gender and racial/ethnic groups is not required as subject selection criteria, but inclusion is encouraged.), OR
• Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect between subgroups.

Guidance and Additional Instructions

If you answered "Yes" to Question 5, then follow the instructions for Scenario F.

If you answered "No," then you need to consider an alternative Scenario. Return to the PHS 398 Instructions Decision Table for Section E.