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.
For additional information, see the
NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research and the
SF424 (R&R) - Version E General Instructions.
