Children & Families
Expanding access to birth control is the surest way to defend women’s right to choose
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
-
February 16
-
Welcome, Introduction, and Meeting Objectives
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
Opening Remarks
RBRachel Behrman Director, Office of Medical Policy, Center for Drug Evaluation and ResearchJRJudy 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
KJRKenneth J. Rothman RTI Health Solutions and RTI InternationalTTHThomas Ten Have University of Pennsylvania School of MedicineSTNSharon-Lise T. Normand Harvard Medical School and Harvard School of Public HealthDBRDonald B. Rubin Harvard University -
Session II: Meta-Analytic Approaches for Combining Multiple Results to the Same Query
JABJesse A. Berlin Johnson & Johnson Pharmaceutical Research and DevelopmentKHKenneth Hornbuckle Eli Lilly and CompanyCHSChristopher H. Schmid Tufts University, Tufts Medical Center and Tufts University School of Medicine -
Session III: Distributed Regression and Related Methods for Signal Refinement
BMBradley Malin Vanderbilt University School of Medicine and School of EngineeringCWCChristopher W. Clifton Purdue University and Indiana Center for Database SystemsJARJeremy A. Rassen Harvard Medical School and Brigham & Women's Hospital -
Session IV: Establishing Operating Characteristics of Active Surveillance Approaches
JJGJoshua J. Gagne Harvard Medical School and Brigham & Women's HospitalAMWAlexander 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
-
