Requirements for NIH-Defined Phase III Clinical Trial Applications

OR:

• Prior studies neither support nor negate significant differences in intervention effect between subgroups:
• Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups (Does not require high statistical power)
  • For the purpose of this policy, Valid Analysis means an unbiased assessment that does not require high statistical power and should be conducted for both large and small studies.

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