Amin - SeeAlso
- Statistical Analysis Plan SAP
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ClinicalTrials.gov defines a Statistical Analysis Plan (SAP) as "The written description of the statistical considerations and methods for analyzing the data collected in the clinical study."
If the proposed research includes a NIH-Defined Phase III Clinical Trial, applicants are required to address plans for how sex/gender, race and ethnicity will be taken into consideration in the design and valid analysis of the trial.
The "Plan to Test for Differences in Effect among Sex/gender, Racial, and/or Ethnic Groups" must include selection and discussion of one of the following analysis plans:
- Plans to conduct analyses to detect significant differences in intervention effect among sex/gender, racial, and/or ethnic subgroups when prior studies strongly support these significant differences among one or more subgroups, or
- Plans to include and analyze sex/gender, racial, and/or ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups. (Representation of sex/gender, racial, and 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, racial, and/or ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect among subgroups.
- See Also: Valid Analysis