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Activity Number: 187
Type: Topic Contributed
Date/Time: Monday, August 7, 2006 : 2:00 PM to 3:50 PM
Sponsor: Section on Bayesian Statistical Science
Abstract - #305846
Title: A Tiered Treatment Design for a Historically Controlled Medical Device Clinical Trial
Author(s): Alistair O'Malley*+
Companies: Harvard Medical School
Address: Department of Health Care Policy, Boston, MA, 02115-5899,
Keywords: Bayesian analysis ; coronary-artery stents ; historical control ; hierarchical modeling ; medical devices ; tiered treatment design
Abstract:

I will describe a novel design for a single-armed trial of a new drug-coated coronary-artery stent. In order to make comparisons against coronary artery bypass graft (CABG) surgery, two historical trials involving a third treatment (bare metal stenting) are used. One of the historical trials compares the drug-coated stent to bare metal stenting, while the other compares bare metal stenting to CABG. I will discuss the advantages and disadvantages of the "tiered treatment design" and present the results from the analysis of the trial. In particular, I will demonstrate that, in this case, the tiered treatment design leads to a different conclusion than the standard historical-control analysis.


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