JSM 2011 Online Program

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Abstract Details

Activity Number: 19
Type: Topic Contributed
Date/Time: Sunday, July 31, 2011 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301686
Title: Good Statistical Practice for Medical Device Trial Submission
Author(s): Huyuan Yang*+ and Matthew Rousseau and Peter Lam
Companies: Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation
Address: Boston Scientific Way, Marlborough, MA, 01752, USA
Keywords: IDE submission ; statistical practice ; Bayesian approach
Abstract:

The presentation will focus on the key statistical components of a good IDE submission and on the best practice. This talk will focus on statistical issues include the assumption used in sample size calculation, missing data sensitivity analyses, and pooling strategies. Case examples of Frequentist and Bayesian approaches will be discussed to illustrate the good statistical practice.


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