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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
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September 21
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Welcome and Introduction
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
Opening Remarks
JRJudy Racoosin Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research -
Session I: Building a Generalized Framework for Signal Refinement
AMWAlexander M. Walker World Health Information Science Consultants, LLCJMJonathan Morris President and Chief Executive OfficerNCSNancy C. Santanello Vice President and Head of EpidemiologyRMCRobert M. Califf Duke Translational Medicine InstituteABAndrew 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 @drJoshS -
Session II: Exploring Data Needs for Signal Refinement through Two Scenarios
DJDavid Juurlink General Internist, Sunnybrook Health Sciences CentreLHCLesley Huntley Curtis Associate Professor in Medicine - Duke University School of MedicineFCFrancesca Cunningham Center for Medication Safety PSCI, Department of Veterans Affairs National Center for Patient Safety and Pharmacy Benefits Management ServicesTLTracy Lieu Professor and Director, Center for Child Health Care StudiesCRChristian Reich Senior Program Manager -
Session III: Exploring Methodological Needs for Signal Refinement through Two Scenarios
SSSebastian Schneeweiss Harvard Medical School and Brigham and Women’s Hospital -
Recap and Closing Remarks
RBRachel Behrman Director, Office of Medical Policy, Center for Drug Evaluation and Research
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