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Activity Number: 153 - Contributed Poster Presentations: Biopharmaceutical Section
Type: Contributed
Date/Time: Monday, August 8, 2022 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #323173
Title: The Win Ratio Approach for Recurrent Events with an Associated Terminal Event - Simulations and Considerations
Author(s): Huihua Li* and Anqi Yin and Ching-Ray Yu
Companies: Pfizer Inc and Georgetown University and Pfizer, Inc
Keywords: Win ratio; Recurrent event analysis; Time to event; Statistical power; study design
Abstract:

Composite outcomes combining fatal and non-fatal events provide more comprehensive information about the impact of the treatments compared. Commonly, such a composite endpoint is analyzed as time to the first event, or by models for recurrent events irrespective of type and clinical relevance. The novel win ratio offered an alternative to the traditional approach through hierarchical ordering of events. It is easily extended to the scenario where a terminal event occupies the primary level of the hierarchy and a recurrent event such as hospitalization occupies the second level.

We present simulation results which compare the win ratio with existing statistical approaches under a variety of clinical scenarios. Simulation parameters are chosen to mimic typical chronic heart failure populations and include scenarios with heterogeneity on recurrent hospitalization, correlation between hospitalization and death, and enrollment duration. Based on these results, we will make recommendations for the choice of the endpoint, and the aspects of clinical trial design required to optimize the performance of win ratio, and lead to a compelling and clinically meaningful trial outcome.


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

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