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Session 8: What’s New in Advancing Signal Detection? Smarter Tools for Safety Evaluation
Session Chair(s)
James Buchanan, PharmD
President
Covilance LLC, United States
This session will provide an update on tools that aid in evaluating causality assessments of drug-induced liver injury (DILI). Some signal detection tools and methods employ various statistical methods, but this session will offer caution with some of these approaches instead highlighting the appropriate application of statistical methods in signal detection. Finally, while the Sentinel program has been a powerful tool for FDA to perform safety risk evaluations, it is not available to the pharmaceutical industry. However, a “subset” of Sentinel, known as IMEDS, is a program for safety evaluations that can be utilized by pharmaceutical companies. Experts in each of these areas will share the latest thinking on these topics.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe how the RECAM method improves upon the RUCAM method for DILI assessments
- Appreciate the appropriate use and limitations of statistics in signal detection and evaluation
- Discuss how sponsors can use the IMEDS tools to evaluate safety signals using Sentinel-level data resources
Speaker(s)
Updates on DILI Causality Assessment
Javier Waksman, MD
PharmaSec LLC , United States
President
Key Considerations to Avoid Misuse of Statistics in Safety Signal Detection and Evaluation
Ed Whalen, PhD
Pfizer Inc, United States
Senior Director, Biostatistics
How the Innovation in Medical Evidence and Development Surveillance (IMEDS) Program Leverages Sentinel Capabilities for Safety Evaluations
Carla Rodriguez-Watson, PhD, MPH
Reagan-Udall Foundation for the FDA, United States
Director of Research
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