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Activity Number: 112
Type: Contributed
Date/Time: Monday, August 7, 2006 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #307194
Title: Bayesian Adaptive Noninferiority Assessment with Safety Measure
Author(s): Melissa Spann*+ and Stacy Lindborg and John W. Seaman
Companies: Eli Lilly and Company and Eli Lilly and Company and Baylor University
Address: 450 South Madison, Indianapolis, IN, 46225,
Keywords: Bayesian ; adaptive ; non-inferiority ; safety measure ; SAS ; WinBUGS
Abstract:

We will present a Bayesian adaptive approach to determining if an experimental treatment is non-inferior to an active control treatment within a clinical trial that includes a placebo arm. The design uses joint posterior predictive probabilities of safety and efficacy to determine adaptive allocation probabilities. As part of a retrospective study, analyses of data from a previously FDA approved treatment were performed. We will present results of those analyses and simulation results using programming executed in SAS and WinBugs.

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