JSM 2004 - Toronto

Abstract #301355

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Activity Number: 405
Type: Contributed
Date/Time: Thursday, August 12, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #301355
Title: Analysis of Clinical Trial Data When Treatments Favor Different Endpoints
Author(s): Leslie A. McClure*+ and Morton B. Brown
Companies: University of Michigan and University of Michigan
Address: School of Public Health, Bldg II, Dept. of Biostatistics, Ann Arbor, MI, 48105-2029,
Keywords: clinical trials ; multiple endpoints
Abstract:

Most clinical trials are designed to have one primary endpoint. However, it is becoming increasingly common to design studies for which more than one primary outcome exists. In these situations, it is important to include all of the primary outcomes in the analyses. Methods that exist for more than one outcome are generally concerned with identifying one of two situations: (1) improvement in all outcomes from one treatment, as compared to the other treatment(s), or (2) improvement in a single efficacy endpoint, without an excess of toxicity. In contrast, the Colpopexy And urinary Reduction Effort (CARE) Study is a randomized clinical trial comparing two treatments, which presents a slightly different scenario. In this study, there are two outcomes, where each treatment may favor a different outcome. Few statistical methods exist to model bivariate data to test joint hypotheses that may be inconsistent in their inference. We will discuss both a likelihood-ratio-based approach and a Bayesian approach to test whether or not a treatment difference exists at the end of the study.

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Revised March 2004