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This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

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Activity Number: 458
Type: Topic Contributed
Date/Time: Wednesday, August 1, 2007 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #309316
Title: Bayesian NonInferiority Trial Design Using Hierarchical Models
Author(s): Yongyi Yu*+ and Frank Zhou and Scott Wehrenberg and Ming-Hui Chen
Companies: Boston Scientific Corporation. and Boston Scientific Corporation and Boston Scientific Corporation and University of Connecticut
Address: 1 Scimed Pl, Maple Grove, MN, 55311,
Keywords: Drug-eluting stent ; Hierarchical model ; Simulation ; MCMC ; Operating Characteristics
Abstract:

A Bayesian trial is proposed to determine if the new generation drug-eluting stents (DES) is non-inferior to the first generation drug-eluting stents. A hierarchical model is used to incorporate historical information available on first generation DES trials. Study success criteria are based on posterior probability of non-inferiority. Sample sizes, borrowing strategy, and corresponding operating characteristics are simulated and compared to frequentist approach.


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Revised September, 2007