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Session 11: How Not to Drown in Data: Can ICH Move us Forward?
Session Chair(s)
Valerie E. Simmons, MD, FFPM
Senior Medical Fellow, Global Patient Safety
Eli Lilly and Company Ltd, United Kingdom
Mariette Boerstoel-Streefland, MD, MBA, MS
Senior Vice President, Worldwide Safety Officer
Bristol-Myers Squibb Company, United States
For several years, an increasing amount of individual case safety data has been noted from multiple sources, particularly in the post marketing setting. In this respect, more data does not necessarily translate into optimized signal detection and evaluation, particularly when originating from certain data sources, notably patient support programmes. Recent published findings have supported concerns that overwhelming safety databases with less informative data from PSPs may not only create false safety signals but also potentially obscure true safety signals. These findings provided an impetuous to the reopening of ICH E2D (R1) which is currently in Step 1. In a parallel initiative, ICH E19 aims to optimize safety data collection in late stage clinical trials, using a selective approach in order to improve the efficiency of these clinical trials, as well as reduce the burden on study participants. ICH E19 was released for consultation in 2019 and is currently being updated based on this feedback. This session will evaluate the status of both ICH guidelines and discuss their anticipated contribution to optimizing safety data collection from both clinical trial and post marketing settings.
Learning Objective : - Understand the need to optimize safety data collection requirements from both clinical trial and post marketing settings
- Understand the stimulus for re-opening ICH E2D and current proposals for safety data collection from PSPs
- Learn about the key challenges to developing standards for optimizing safety data collection in a CT setting and how Step 2 consultation feedback is being addressed
Speaker(s)
Speaker
Vicki Edwards, RPh
Abbvie, United Kingdom
Vice President, Pharmacovigilance Excellence and International QPPV
Speaker
Ellis Unger, MD
Hyman, Phelps & McNamara, P.C., United States
Principal Drug Regulatory Expert
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