Reviewing Statistical Analysis Plans—A Guide for Medical Writers

Abstract

Over recent years, medical writing has become an integral activity in drug development through the production of high-quality regulatory documents, thus expediting the approval process. In a similar vein, the importance of statistical considerations in drug development has also been increasingly recognized. In particular, the development of a study-specific statistical analysis plan (SAP) is now perceived as best practice for regulatory (and other) studies and is required in many instances. There is a clear need for medical writers and biostatisticians to work closely together during the course of a project; thus, it is advantageous for the medical writer to make a contribution to the development of the SAP. The aim of this article is to detail the benefits to both medical writers and biostatisticians of the project medical writer reviewing the SAP and to highlight the specific issues that should be addressed during the review process. We recommend that this re-view become a routine activity in all pharmaceutical companies and contract research organizations.