This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 665
Type: Topic Contributed
Date/Time: Thursday, August 5, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #308832
Title: Bayesian Hierarchical Models for Detecting Safety Signals in Clinical Trials
Author(s): Haijun Ma*+ and Amy Xia and Bradley P. Carlin
Companies: Amgen Inc. and Amgen Inc. and University of Minnesota
Address: , , 91320,
Keywords: safety signal ; clinical trial safety ; adverse event ; Bayesian ; meta-analysis ; statistical graphics
Abstract:

Clinical trial adverse event (AE) data is one of the primary sources for safety signal detection in drug development. How to deal with issues such as multiplicity, rare event and meta-analyzing information from multiple trials is statistically challenging. Bayesian modeling is helpful to tackle such problems. In this presentation, we incorporate the existing AE coding structure into Bayesian hierarchical modeling in a meta-analysis setting. Some effective graphics are used for displaying data and communicating analysis results.


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