Bayesian Medical Device Clinical Studies in the Regulatory Setting Keywords: Bayesian methods, medical devices, clinical trials Bayesian methods have been used in the design and analysis of medical device clinical trials for submission to the Food and Drug Administration for over 10 years. They have been particularly helpful, not only due to the availability of prior information, but also because they provide flexibility with respect to interim analyses, prediction, meta-analysis, and dealing with missing data. Currently, the Center for Devices and Radiological Health at the FDA is also exploring the use of formal Decision Analysis methodology, which is inherent to the Bayesian approach. 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 in the regulatory setting and summarize what has been happening at the Center for Devices and Radiological Health at the FDA since the Bayesian initiative was launched at CDRH.
|
Important Dates & Deadlines
- May 31, 2011
Registration Deadline for All Session Presenters - September 1, 2011
Poster Abstract Online Submission Closes - September 9, 2011
Hotel Reservations Close - September 15, 2011
Conference Registration Closes