Keywords: Win ratio, generalized analytic solution, composite endpoint
A composite endpoint consists of multiple components combined in one outcome. It is frequently used as the primary endpoint in cardiovascular, oncology, transplant and other therapeutic areas. There are two main disadvantages associated with the use of composite endpoints: a) conventional approaches treat its components equally; and b) in time-to-event analyses, the first event occurred may not be the most important component. Pocock et al. (2012) introduced the win ratio method to address these disadvantages, among other methods developed by other researchers. The win ratio is a straightforward method that takes into account the order of importance of the different components: it compares each subject in the Treatment group with every subject in the Control group to determine who is the “winner” or the “loser” based on the prioritized components, and then it takes the ratio of the number of winners in the Treatment group to that in the Control group.
During the past few years, the win ratio has been applied in the design and analysis of some clinical trials, and there are also some new methodological developments such as Luo et al. (2015), Bebu and Lachin (2016), Wang and Pocock (2016), Oakes (2016), and Dong et al. (2016). This presentation will briefly review the win ratio and its methodological developments and applications in some clinical trials; and then focus on the most recent method published by Dong et al. (2016). This method provides a generalized analytic solution that is valid for any way of defining winners, losers and ties.