Drug Evaluation Committee Survival Time-Type Response Metrics (2nd Edition) Understanding RMST (Restricted Mean Survival Time)
March 2019
The Data Science Subcommittee of the Drug Evaluation Committee’s Task Force 4 for FY2017–18 compiled a summary of evaluation metrics for survival-type responses.
In recent years, discussions have begun in clinical journals regarding the use of RMST (restricted mean survival time) as one of the alternative metrics when proportional hazards do not hold. However, there are no published books focused specifically on RMST, and we believed that practical consideration of its properties is necessary for its real-world application.
This report provides an explanation not only of the theoretical aspects of RMST but also of practical information, such as programming. Furthermore, since a certain level of understanding is required on the part of clinical staff when selecting the most appropriate outcome measure for a given situation, Chapter 2 uses diagrams to organize the various outcome measures in a way that facilitates intuitive understanding.Not only for RMST but also when interpreting the results of clinical trials in general, it is important to translate the statistical interpretation of the analysis results into a clinical interpretation. To achieve this, it is considered essential to select and evaluate endpoints that can be appropriately interpreted depending on the situation.
We hope this report will be of assistance.
In the 2nd Edition (published in March 2019), we have introduced the latest case studies on RMST and added explanations of SAS macros for implementing information content calculations and survival time data reconstruction, as well as details on implementing RMST analysis in SAS/STAT 15.1.