JSM 2004 - Toronto

Abstract #301325

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Activity Number: 121
Type: Contributed
Date/Time: Monday, August 9, 2004 : 12:00 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301325
Title: Checking Model Assumptions--Getting the BUGS Out
Author(s): Steven A. Gilbert*+
Companies: Rho, Inc.
Address: 199 Wells Ave., Newton, MA, 02459,
Keywords: BUGS ; clinical trial
Abstract:

Clinical trials destined for FDA submission are generally analyzed in a frequentist framework. It is not uncommon to find that modeling assumptions are violated, as indicated by the presence of skewed or heavy-tailed residuals, nonlinear relationships, or outlying values. Unfortunately, it is often difficult to explore the extent to which the violations of the assumptions adversely affect the inferences drawn from the frequentist models. However, a Bayesian analysis that accounts for some of the unmet modeling assumptions can be performed using WinBUGs, and the results can be compared to the inferences generated using standard analyses. We examine several datasets based on actual clinical trials, and explore the practical aspects of combining the frequentist and Bayesian approaches.

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Revised March 2004