Conference Program

Win Ratio, Win Odds, and Net Benefit: Decade Achievements and Future Perspectives (303682)

View Presentation

*Jialu Zhang, Office of Biostatistics, Division of Biometrics 2 

Keywords: win ratio, regulatory

In recent years, the Win Ratio test has been used in the registration trials due to its flexibility that can incorporate different types of variables into one composite endpoint and its hierarchical structure that can order components based on the clinical importance. In 2019, tafamidis was approved for treating the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) based on the Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT). Unlike a traditional cardiovascular outcome trial, this trial’s composite primary endpoint includes both time-to-event and categorical variables. Win Ratio test was used to analyze the composite endpoint. Some regulatory experience on tafamidis will be shared and questions will be raised to discuss when and how to use the Win Ratio test.