Checklist for preparing a Statistical Analysis Plan for Clinical Trials...
- Provide a detailed description of the primary and secondary endpoints and how they are to be measured.
- Provide details of the statistical methods and tests that will be used to analyze the endpoints. The analysis of the primary outcome must follow the principle of intention-to-treat.
- Describe the strategy to be used (e.g., alternative statistical procedures) if the distributional or test assumptions are not satisfied.
- Detail whether comparisons will be one-tailed or two-tailed (with appropriate justification if necessary) and specify the level of significance to be used.
- Identify whether any adjustment to the significance level or the final P values will be made to account for any planned or unplanned multiple testing or subgroup analyses.
- Specify potential adjusted analyses with a statement of which covariates or factors will be included.
- Identify any planned subgroup or subset analysis along with justification for the relevance of this analysis (eg, biological rationale) before commencement of the trial.
- Specify planned exploratory analyses, justifying their importance.
- Support claimed differential subgroup effects with biological rationale and supporting evidence from within and outside the study.
- Provide statistical evidence of interaction between the overall treatment effect and that observed in the subgroup(s) of interest.
- Remember that pre-specified subgroups will have more interpretive value than those defined on an ad-hoc basis or as a result of multiple comparisons.
