The Win Ratio Approach in Bayesian Monitoring for Two-Arm Phase II Clinical Trial Designs With Multiple Time-To-Event Endpoints.

ABSTRACT: To assess the preliminary therapeutic impact of a novel treatment, futility monitoring is commonly employed in Phase II clinical trials to facilitate informed decisions regarding the early termination of trials. Given the rapid evolution in cancer treatment development, particularly with new agents like immunotherapeutic agents, the focus has often shifted from objective response to time-to-event endpoints. In trials involving multiple time-to-event endpoints, existing monitoring designs typically select one as the primary endpoint or employ a composite endpoint as the time to the first occurrence of any event. However, relying on a single efficacy endpoint may not adequately evaluate an experimental treatment. Additionally, the time-to-first-event endpoint treats all events equally, ignor

SUBMITTER: Huang X 

PROVIDER: S-EPMC11645213 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature