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Activity Number: 340 - New Advances in Analysis of Social Science Research
Type: Contributed
Date/Time: Tuesday, August 1, 2017 : 10:30 AM to 12:20 PM
Sponsor: International Chinese Statistical Association
Abstract #323267 View Presentation
Title: On Bayesian Safety Monitoring
Author(s): Hal Li* and William Wang
Companies: Merck Research Laboratories and Merck
Keywords: Bayesian analysis ; safety monitoring ; Interim-Analyses

On Bayes Interim-Analyses for Dynamic Safety Monitoring

Hal Li1, William Wang1

1Merck Research Laboratories, 351 N Sumneytown Pike, North Wales, PA 19454


During clinical development and product life cycle of pharmaceutical products, safety monitoring is a dynamic, iterative process for safety evaluation, risk management and risk communication. Bayesian approach designed for learning and adaptive decision making is a natural methodology for these evaluations.

In this presentation, we discuss a proactive approach for monitoring safety profile, in response to unexpected events and events of special interest. The Bayesian interim analysis methods are discussed. We have developed a hybrid approach that combines Bayesian modeling with the frequentist approach to interim-analysis. The implications of this approach are presented, including Bayesian stopping rules as well as current FDA guidance on Bayesian analysis. We will also address the process of controlling for the possibility of false finding.

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

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