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Past Event

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:

  1. Association between an oral anti-diabetes drug and acute myocardial infarction
  2. Association between an injectable antibiotic drug (administered in an inpatient setting) and acute liver injury


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


Andrew Bate

Senior Director, Analytics Team Lead in Epidemiology

Keynote Address

Session II: Exploring Data Needs for Signal Refinement through Two Scenarios


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

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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