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Abstract Details

Activity Number: 81
Type: Contributed
Date/Time: Sunday, July 29, 2012 : 4:00 PM to 5:50 PM
Sponsor: Section on Bayesian Statistical Science
Abstract - #305667
Title: Bayesian Method: Powerful, but Not Magical
Author(s): Freda Cooner*+
Companies: FDA/CDER/OTS/OB
Address: 10903 New Hampshire Ave., Silver Spring, MD, 20993, United States
Keywords: Bayesian ; Priors ; Clinical Studies
Abstract:

Bayesian methodology, a once burdensome method, has become a powerful, sophisticated and efficient analytic tool. Bayesian scientists are now able to solve issues that have challenged many frequentists. Clinical investigators have begun to recognize the many benefits of Bayesian methodologies. Hence, it is used not only in analyzing data, but also in clinical trial design for both safety and efficacy. However, researchers often seem oblivious to some of the methodological pitfalls, or, perhaps, they may have some misconceptions regarding what the Bayesian approach can truly provide. It is important to understand the Bayesian framework before applying it to a clinical study and expecting that it will "magically" resolve potential analysis issues. This presentation will focus on the application of this adaptive methodology, starting with a brief discussion of its advantages in the clinical settings. Then we will discuss some important limitations. We note that some advantages attributed to Bayesian methodology are, in fact, neither advantages nor of Bayesian origin. The presentation will conclude with some points to consider for advocates of the Bayesian method.


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