Bayesian Adaptive Medical Device Trials in the Regulatory Setting
Telba Z. Irony, FDA/CDRH Keywords: The use of Bayesian statistics in analyses of medical device clinical trials for premarket submissions to the Food and Drug Administration has increased considerably in recent years. In the medical device arena, Bayesian analysis is particularly helpful in because it provides flexibility with respect to interim analyses, prediction, meta analysis, and missing data. In this presentation we will discuss the designs and techniques that have been successfully used in premarket applications, highlight the peculiar problems and solutions for implementation of such techniques and discuss how Bayesians estimate the treatment effect of adaptive trials in the regulatory setting.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC