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Activity Number:
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373
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 1, 2007 : 8:30 AM to 10:20 AM
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Sponsor:
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Section on Bayesian Statistical Science
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| Abstract - #309028 |
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Title:
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Bayesian Designs and Therapeutic Medical Device Trials
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Author(s):
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Pablo Bonangelino*+
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Companies:
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Food and Drug Administration
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Address:
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CDRH, 1350 Piccard Dr, Rockville, MD, 20850,
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Keywords:
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Bayesian ; medical device ; CDRH
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Abstract:
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This talk will review the Bayesian designs which have been used in medical device trials that have been submitted to the General and Surgical Devices Branch of FDA's Center for Devices and Radiological Health (CDRH) in recent years. I will begin with an overview of the approach taken by our Branch towards Bayesian statistical methods. I will then discuss examples of Bayesian methods, which include likelihood based methods for incomplete data, Bayesian adaptive designs using predictive probability, and incorporating prior data in a confirmatory study. Regulatory considerations regarding these designs are explored. I will conclude by considering the future for Bayesian techniques in therapeutic device studies.
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