Methods for Signal Refinement in Active Medical Product Surveillance
On September 21, the Engelberg Center for Health Care Reform hosted a one-day expert workshop to discuss the most effective and efficient ways to carry out the signal refinement step of active medical product surveillance. For the purposes of the meeting, signal refinement was defined as the step of active surveillance after signal generation, when a potential association between a medical product and health outcome is identified, and before signal evaluation, where formal epidemiological analyses are implemented. Potential steps in signal refinement are shown in the diagram below.
Experts from academia, the private sector, and FDA discussed several topics including:
- Approaches to building a generalized framework for signal refinement applicable to a broad range of medical products
- Acceptable levels of uncertainty in signal refinement
- Data needs for signal refinement
- Methodological needs and approaches for signal refinement
Two hypothetical scenarios helped to guide discussion about signal refinement data and methodological needs:
- Association between an oral anti-diabetes drug and acute myocardial infarction
- Association between an injectable antibiotic drug (administered in an inpatient setting) and acute liver injury
Agenda
Welcome and Introduction
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Opening Remarks
Judy Racoosin
Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research
Session I: Building a Generalized Framework for Signal Refinement
Alexander M. Walker
World Health Information Science Consultants, LLC
Jonathan Morris
President and Chief Executive Officer
Nancy C. Santanello
Vice President and Head of Epidemiology
Robert M. Califf
Duke Translational Medicine Institute
Andrew Bate
Senior Director, Analytics Team Lead in Epidemiology
Keynote Address
Joshua M. Sharfstein
Vice Dean for Public Health Practice and Community Engagement; Professor of the Practice - Johns Hopkins Bloomberg School of Public Health
Session II: Exploring Data Needs for Signal Refinement through Two Scenarios
David Juurlink
General Internist, Sunnybrook Health Sciences Centre
Lesley Huntley Curtis
Associate Professor in Medicine - Duke University School of Medicine
Francesca Cunningham
Center for Medication Safety PSCI, Department of Veterans Affairs National Center for Patient Safety and Pharmacy Benefits Management Services
Tracy Lieu
Professor and Director, Center for Child Health Care Studies
Christian Reich
Senior Program Manager
Session III: Exploring Methodological Needs for Signal Refinement through Two Scenarios
Recap and Closing Remarks
Rachel Behrman
Director, Office of Medical Policy, Center for Drug Evaluation and Research
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