Abstract #300694

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JSM 2002 Abstract #300694
Activity Number: 291
Type: Contributed
Date/Time: Wednesday, August 14, 2002 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section*
Abstract - #300694
Title: Designing Clinical Trials When Treatments Favor Different Endpoints
Author(s): Leslie McClure*+ and Morton Brown
Affiliation(s): University of Michigan and University of Michigan
Address: 1420 Washington Heights, Ann Arbor, Michigan, 48109, USA
Keywords: multiple outcomes ; interim analysis
Abstract:

It is becoming increasingly common in clinical trials to design studies for which more than one primary endpoint exists. For safety reasons, monitoring all of the endpoints simultaneously is necessary. Most methods developed to monitor data throughout a randomized clinical trial are not suitable for evaluating more then one outcome. Those that do exist generally concentrate on monitoring a single efficacy endpoint and a single toxicity endpoint. We propose a method for the analysis of multiple primary outcomes. In particular, we focus on the situation where there are two dependent outcomes, and each treatment may favor a different endpoint.

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Revised March 2002