JSM 2005 - Toronto

Abstract #304694

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Activity Number: 449
Type: Contributed
Date/Time: Wednesday, August 10, 2005 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304694
Title: A Bayesian Test for Binary Outcomes in Fixed-dose Combination Drug Studies
Author(s): Melinda Holt*+ and James Stamey and John Seaman and Dean M. Young and Dean M. Young
Companies: Southeastern Louisiana University and Stephen F. Austin State University and Baylor University and Baylor University and Baylor University
Address: PO Box 10687, Hammond, LA, 70402, United States
Keywords: Superiority ; Min Test ; Sample Size ; Estimation
Abstract:

We use a Bayesian analysis to determine the superiority of a combination over its components, a prevalent issue in fixed-dose combination trials. The approach described here does not require knowledge of the dose-response relationships of the components or large sample approximations. Our method requires only one dose level of each drug. It can incorporate existing prior information and allows direct calculation of the posterior probability that the mixture is superior to its components. It also allows a measure of the degree of superiority. These methods provide a Bayesian alternative to the existing Min test. We present a simplification of results that allows the use of numerical integration, but also apply the Gibbs sampler through the WinBugs software package. In addition, we explore issues of sample size and discuss performance under conditions where the Min test proved to be excessively conservative.

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