A template for the authoring of statistical analysis plans

Abstract

A number of principal investigators may have limited access to biostatisticians, a lack of biostatistical training, or no requirement to complete a timely statistical analysis plan (SAP). SAPs completed early will identify design or implementation weak points, improve protocols, remove the temptation for p-hacking, and enable proper peer review by stakeholders considering funding the trial. An SAP completed at the same time as the study protocol might be the only comprehensive method for at once optimizing sample size, identifying bias, and applying rigor to study design. This ordered corpus of SAP sections with detailed definitions and a variety of examples represents an omnibus of best practice methods offered by biostatistical practitioners inside and outside of industry. The article presents a protocol template for clinical research design, enabling statisticians, from beginners to advanced.