237 – Quantitative Sciences for Safety Monitoring and Confirmatory Safety in Clinical Development
Safety-Monitoring Methodology in the Premarketing Setting
Michael Fries
CSL Behring
Karolyn Kracht
AbbVie Inc
Judy Li
FDA
Melvin Munsaka
Takeda Inc.
Matilde Sanchez-Kam
SanchezKam LLC
Krishan Singh
Glaxo Smith Kline Plc
William W.B Wang
Merck Research Laboratories
Ed Whalen
Pfizer Inc.
Kefei Zhou
Amgen Inc.
To better promote public health and protect patient safety, there is growing interest for systematic approaches for safety evaluation of drug products. This applies to both post-marketing and pre-marketing settings. Recent regulatory guidance highlights the importance and provides recommendations on aggregate safety monitoring. Safety monitoring, spans from individual trial level to program level, from unblinded to blinded, from expected to unexpected AEs and from patient profiles to aggregate safety tables and figures, supporting DMC and benefit-risk assessments and serves to lay a foundation for IAS preparation and benefit-risk assessment. To better enable this, the ASA Biopharm Section in 2015 established a Safety Working Group. One focus areas of the working group is safety monitoring. This presentation will discuss part of the work of this working group. The discussion will focus on the methodological approaches for safety monitoring in the pharmaceutical development life cycle, including, blinded vs unblinded, frequentist vs Bayesian, and premarketing vs post marketing methods, static vs dynamic looks, visualization, and trial-level vs program-level safety data aggregation.