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Activity Number: 148 - Considerations in Clinical Trial Endpoints’ Selection
Type: Invited
Date/Time: Tuesday, August 10, 2021 : 10:00 AM to 11:50 AM
Sponsor: Biopharmaceutical Section
Abstract #316608
Title: Win Statistics: Impact of Follow-up Time and Unbiased Estimators of Treatment Effect in the Presence of Censoring
Author(s): Gaohong Dong* and Victoria Chang and Bo Huang and James Song and Duolao Wang and Lu Mao and Jiuzhou Wang and Johan Verbeeck and Margaret Gamalo-Siebers and David C. Hoaglin
Companies: BeiGene and BeiGene and Pfizer Inc. and BeiGene and Liverpool School of Tropical Medicine, UK and University of Wisconsin and ImmunoGen Inc. and University Hasselt, Belgium and Pfizer Inc. and University of Massachusetts Medical School
Keywords: Win ratio; Net benefit; Win odds; IPCW; inverse-probability-of-censoring weighting; Censoring
Abstract:

For composite outcomes whose components can be prioritized on clinical importance, following generalized pairwise comparisons (GPC), patients in the two groups can be compared using importance order to produce wins and subsequently win proportions. Because the win ratio (ratio of win proportions), the net benefit (difference in win proportions) and the win odds (odds of win proportions) are derived using the same win proportions and they test the same hypothesis of equal win probabilities in the two groups, we refer to them as win statistics. In this talk, we will focus on the censoring issues of time-to-event outcomes. We will first present impact of follow-up time. If the treatment has a long-term benefit from a more important but less frequent endpoint (eg, death), the win statistics can show this benefit by following patients longer. Then, we will show that inverse-probability-of-censoring weighting (IPCW) can correct the win statistics from censoring bias, and IPCW-adjusted and CovIPCW (IPCW with baseline and/or time-dependent covariates that can predict dependent censoring) adjusted win statistics are unbiased estimators of treatment effect in the presence of censoring.


Authors who are presenting talks have a * after their name.

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