What is often found in a statistical analysis plan (SAP)?

In a statistical analysis plan (SAP), details of inferential analyses to be performed are included as a fundamental aspect. The SAP outlines the statistical methods and analyses that will be applied to the data collected during a clinical trial. This includes specifying which statistical tests will be used, how hypotheses will be tested, and how data will be handled, including any methods for addressing missing data or outliers.

The purpose of the SAP is to ensure a clear and predetermined approach to the analysis, thereby minimizing bias and enhancing the reproducibility of results. By detailing the inferential analyses, the SAP serves as a roadmap for statisticians and researchers to follow once the data is collected, which is crucial for the integrity of the study findings. This clarity helps ensure that all stakeholders understand how the data will be analyzed and interpreted at the conclusion of the trial.