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

Abstract Details

Activity Number: 554
Type: Invited
Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
Sponsor: ENAR
Abstract - #306230
Title: Bayesian Applications in Drug Safety Evaluation
Author(s): Amy Xia*+
Companies: Amgen Inc.
Address: One Amgen Ctr Dr, Thousand Oaks, CA, 91320,
Keywords: Drug Safety ; Bayesian Hierarchical Modeling ; Signal Detection ; Safety Monitoring ; Rare Events

Safety assessment is critical in drug development and has called increasing attention recently. There are a few challenges in drug safety evaluation: How to detect unexpected adverse drug reactions while handling the multiplicity issue properly? How to deal with rare events? How to evaluate multidimensional, complex safety information as a whole? Bayesian hierarchical modeling offers many advantages and can be used to address these challenges. Specific applications include clinical trial signal detection, meta-analysis for rare adverse event data, and joint modeling of longitudinal and time-to-event data. Another area of application is continuously monitoring an adverse event of interest in which useful prior information can be incorporating into the decision making process. Advantages and challenges of Bayesian methods in these applications will be discussed.

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