Design, Analyze, Communicate: Working together to improve clinical study outcomes.
A statistical analysis plan (SAP) describes the variables that will be collected during a clinical study and the statistical methods that will be used to analyze them. Preparing a comprehensive SAP at the same time as the study protocol is a best practice in clinical research. Completing these tasks concurrently provides many advantages: improvements in the protocol and design; a commitment to not changing what will be measured or analyzed; guidance to the data safety and monitoring board and to those implementing the study on exactly how to perform certain operations; and an increased likelihood of poweredness and less bias.
Despite the benefits of a comprehensive SAP, however, researchers don’t have easy access to complete, high-quality templates to help them prepare one effectively. This SAP Template was developed to fill that gap. It includes all the elements that researchers need to consider to prepare an SAP and detailed notes to help researchers address them. The SAP Template was compiled and reviewed by a team of expert biostatisticians.
Publication: https://www.sciencedirect.com/science/article/pii/S2451865423000467
Citation: Stevens G, Dolley S, Mogg R, Connor JT. A template for the authoring of statistical analysis plans. Contemporary Clinical Trials Communications. 2023 Aug 1;34:101100.
