Increasing calls for transparency, reproducibility and data sharing within clinical trials have led to a greater emphasis on the early development and publication of robust Statistical Analysis Plans (SAPs). Whilst there is guidance on statistical principles for clinical trials, there was no agreed guidance on what should be included within SAPs which led to a marked variation in practice.
A checklist of 32 minimum items for inclusion in SAPs was developed with the primary intention of being applicable to the final analyses of later-phase randomized clinical trials addressing the minimum recommended content of a SAP within the context of the following assumptions:
- The SAP is not a standalone document and should be read in conjunction with the clinical trial protocol;
- The clinical trial protocol should be consistent with the principles of the SPIRIT 2013 Statement; and
- The SAP is to be applied to a clean or validated data set for analysis.
The statement was developed through an extensive and iterative process involving funders, regulatory authorities, journals, industry representatives and UK Clinical Research Collaboration registered Clinical Trial Units (UKCRC CTUs). Further details of the development process can be found in JAMA.
A more in-depth explanation of each checklist item can be found in the elaboration document.
The SAP statement is included in the Equator Network.