JSM 2012 Home

JSM 2012 Online Program

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

Online Program Home

Abstract Details

Activity Number: 165
Type: Topic Contributed
Date/Time: Monday, July 30, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #304863
Title: Good Practice of Bayesian Submission for Medical Devices
Author(s): Xuefeng Li*+ and Pablo Bonangelino
Companies: FDA and FDA
Address: 10903 New Hampshire Ave, Silver Spring, MD, 20993, United States
Keywords: Bayesian Trials ; Medical Devices

Successful Bayesian submission for medical device follows a set of clear and simple good practices. These principles include: flexibility/adaptability; direct probability statements about a parameter; use of accumulating information for prediction; and, use of priors to augment current analyses. After a discussion of what are practically very important adaptive designs with non-informative priors, I will talk about the problem of Type I error with the use of informative priors and discuss several ways to approach this issue. I will conclude with a summary of an internally developed quality assessment for Bayesian IDE evaluation.

The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.

Back to the full JSM 2012 program

2012 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.