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Activity Number: 251
Type: Contributed
Date/Time: Monday, August 1, 2016 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #319693 View Presentation
Title: Precision Medicine: How Bayesian Empirical Subgroup Analysis Plays a Role
Author(s): Judy X. Li* and Wei-Chen Chen and John Scott
Companies: FDA and FDA/CBER and FDA
Keywords: precision medicine ; Bayesian empirical meta analytical prior ; subgroup analysis

Precision medicine development depends on accurately evaluating heterogeneous treatment response across different subgroups of patients. Although subgroup analyses are routinely recommended and performed, identifying relevant subgroups and interpreting the results of analyses remains a difficult challenge. In this talk, we will present a novel Bayesian approach for performing subgroup analyses that overcomes a number of these challenges. We will describe an empirical Bayesian meta-analytic predictive approach for quantifying subgroup treatment effects. Using simulation studies, we will compare this approach to several existing approaches, and we will also illustrate the approach with an example application to clinical studies.

Authors who are presenting talks have a * after their name.

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