Expert Workshop: Statistical and Epidemiological Issues in Active Medical Product Surveillance
The U.S. Food and Drug Administration (FDA) is developing the capacity for active medical product surveillance, which will enhance the agency’s ability to monitor the safety of marketed medical products. This new capacity will come in the form of the Sentinel System, which is currently being piloted through a project known as Mini-Sentinel. Accomplishing the goals of active medical product surveillance will require further development of new and existing methods and tools.
On February 16, the Engelberg Center for Health Care Reform hosted a one-day expert workshop to discuss some of the most pressing methodological issues facing active medical product safety surveillance. At this workshop, experts from academia, the private sector, FDA and other government agencies discussed several topics, including:
- Appropriate analysis and interpretation of signals in the context of large sample sizes
- Analyzing horizontally and vertically partitioned data
- Evaluating the performance of active surveillance methods
Agenda
Welcome, Introduction, and Meeting Objectives
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Opening Remarks
Rachel Behrman
Director, Office of Medical Policy, Center for Drug Evaluation and Research
Judy Racoosin
Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research
Session I: Signal Refinement in the Context of Large Sample Sizes
Kenneth J. Rothman
RTI Health Solutions and RTI International
Thomas Ten Have
University of Pennsylvania School of Medicine
Sharon-Lise T. Normand
Harvard Medical School and Harvard School of Public Health
Donald B. Rubin
Harvard University
Session II: Meta-Analytic Approaches for Combining Multiple Results to the Same Query
Jesse A. Berlin
Johnson & Johnson Pharmaceutical Research and Development
Kenneth Hornbuckle
Eli Lilly and Company
Christopher H. Schmid
Tufts University, Tufts Medical Center and Tufts University School of Medicine
Session III: Distributed Regression and Related Methods for Signal Refinement
Bradley Malin
Vanderbilt University School of Medicine and School of Engineering
Christopher W. Clifton
Purdue University and Indiana Center for Database Systems
Jeremy A. Rassen
Harvard Medical School and Brigham & Women's Hospital
Session IV: Establishing Operating Characteristics of Active Surveillance Approaches
Joshua J. Gagne
Harvard Medical School and Brigham & Women's Hospital
Alexander M. Walker
World Health Information Science Consultants, LLC
Recap and Closing Remarks
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
More Information
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