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Activity Number: 350 - Statistical Issues In Drug Development - 1
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #330310 Presentation
Title: Application of Bayesian Approach in Evaluating Rare Adverse Events During a Clinical Study
Author(s): Ying Grace Li*
Companies: Eli Lilly and Company
Keywords: Bayesian application; rare adverse events; clinical study

Bayesian analysis is gaining broader application in decision making throughout the drug development process, due to its more intuitive framework and ability to provide direct probabilistic answers to complex problems. Identifying the risk profile for a compound throughout phases of drug development is crucial through the most appropriate analyses. This presentation will focus on the challenges of the frequentist approach to detect and evaluate potential safety signals in the rare event setting. The proposed Bayesian approach offers much more flexibility and a more direct probabilistic interpretation that improves the process of detecting rare safety signals. This approach highlights the strength of Bayesian methods for inference and its potential to increase quality of decision making in drug development.

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

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