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Session 9: Planning a Trial with Safety in Mind
Session Chair(s)
James Buchanan, PharmD
President
Covilance LLC, United States
Understanding the safety profile of an investigational drug is best accomplished when there is safety planning to ensure data collection will answer key questions from health authorities, prescribers and patients. Such a plan will ensure a consistent approach to collection and analysis of safety data, describe approaches to ongoing aggregate data analysis and identify knowledge gaps to be addressed in post-marketing safety surveillance or studies. A proposed tool is the Aggregate Safety Assessment Plan which is a modular, multidisciplinary approach to safety planning.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify safety topics of interest and how these can require supplemental data collection forms and/or case adjudication
- Determine when “standard” data analyses are insufficient and what type of additional analyses and graphical displays are required
- Recognize knowledge gaps and how to best acquire the missing information
Speaker(s)
Speaker
Barbara Hendrickson, DrMed, MD
University of Chicago, United States
Clinical Associate, Pediatric Infectious Diseases
Speaker
Lothar Tremmel, PhD
CSL Behring, United States
Vice President, Quantitative Clinical Sciences and Reporting
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