Work

A template for the authoring of statistical analysis plans

Year: 2023

Type: article

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.

Source: Contemporary Clinical Trials Communications

DOI: 10.1016/j.conctc.2023.101100

Authors: Gary Stevens, Shawn Dolley, Robin Mogg, Jason T. Connor

Institution: University of Central Florida

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

Open Access status: gold

Estimated APC paid: $1,915

Funder: Bill and Melinda Gates Foundation