Requirements for NIH-Defined Phase III Clinical Trials
Research plan must include one of the following:
- Prior studies support significant differences between subgroups:
- Need plans to conduct valid analyses to detect significant differences between sex/gender and/or racial/ethnic subgroups
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- For the purpose of this policy, Significant Difference is defined as a difference that is of clinical or public health importance based on substantial scientific data. This is not the same as “statistically significant difference.”