JSM 2005 - Toronto

Abstract #302309

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 85
Type: Invited
Date/Time: Monday, August 8, 2005 : 8:30 AM to 10:20 AM
Sponsor: ENAR
Abstract - #302309
Title: Group Sequential Clinical Trials with Multiple Primary Endpoints
Author(s): Michael Kosorok*+ and Shuangge Ma
Companies: University of Wisconsin, Madison and University of Washington
Address: K6/428 Clinical Science Center, Madison, WI, 53792-4675,
Keywords: Alpha-spending function ; Beta-spending funciton ; Multivariate outcomes ; Sample size ; Time-to-event data
Abstract:

In many phase III clinical trials, it is desirable to separately assess the treatment effect on two or more primary endpoints. Consider the MERIT-HF study, where two endpoints of primary interest were time to death and the earliest of time to first hospitalization or death. It is possible that treatment has no effect on death but a beneficial effect on first hospitalization time, or it has a detrimental effect on death but not effect on hospitalization. A good clinical trial design should permit early stopping as soon as the treatment effect on both endpoints becomes clear. In this paper, we develop a general methodology for group sequential clinical trials with multiple primary endpoints. This method uses a global alpha-spending function to control the overall type I error and a multiple decision rule to control error rates for concluding wrong alternative hypotheses. The method is demonstrated with two simulated examples based on the MERIT-HF study.

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Revised March 2005