Designing superiority trials with window mean survival time as a primary endpoint

Abstract Window mean survival time (WMST), a simple extension of restricted mean survival time (RMST), allows for clinicians to evaluate the mean survival difference between treatment groups in specific windows of time during the follow‐up period of a trial. The advantages of WMST are numerous. Not only does it produce estimates of treatment effect that can be meaningfully interpreted, but also has power advantages over competing methods when hazards are non‐proportional (NPH). WMST, like RMST, is currently underutilized due to clinicians' lack of familiarity with tests comparing mean survival times and the lack of tools to facilitate trial design with this endpoint. The aim of this article is to provide investigators with insights and software to design trials with WMST as the primary endpoint. Functions for performing power and sample size calculations are provided in the survWMST package in R available on GitHub.