The Duke-Margolis Center for Health Policy hosted the 8th Annual Sentinel Initiative Public Workshop at the Renaissance Washington, DC Dupont Circle Hotel. This annual workshop serves as a forum to bring together leading experts and interested stakeholders to discuss the development of the Sentinel Initiative. With the passage of the Food and Drug Administration Amendments Act of 2007, Congress mandated that the U.S. Food and Drug Administration (FDA) develop a national electronic system to track the safety of regulated medical products. In response to this charge, FDA launched the Sentinel Initiative in 2008. Mini-Sentinel, a pilot project of the Sentinel Initiative, utilizes electronic health care data for postmarket risk identification and analysis of medical product safety. Since 2008, Mini-Sentinel has continued to develop with great interest from the stakeholder community and recently transitioned from pilot project to the full Sentinel System to help expand and enhance the FDA’s surveillance capabilities.
Specific topics that were addressed during the workshop include:
- An overview of the current state of Sentinel safety surveillance activities;
- Uses of Sentinel in medical product evaluations;
- Development of current and future Sentinel tools and methods;
- Sentinel’s role as a national resource for evidence generation; and
- Stakeholder feedback on opportunities to enhance and modernize the Sentinel System.
Funding for this conference was made possible in part by a cooperative agreement from the Food and Drug Administration, Center for Drug Evaluation Research. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.
The workshop was captured on video and the segments displayed below are as follows:
Part 1: Welcome and Overview; Keynote Address; The Sentinel Initiative: Perspective from FDA’s Leadership; State of Sentinel Safety Surveillance Activities
Part 2: Selected Sentinel Medical Product Evaluations; Current and Future Development of the Sentinel System
Part 3: Developing a National Resource for Evidence Generation
Part 4: Stakeholder Perspectives on Opportunities to Enhance and Modernize Postmarket Drug Safety Surveillance; Closing Remarks
Steven Anderson PhD, MPP; Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
Kathleen Blake MD, MPH; Vice President, Performance Improvement, American Medical Association
Jeffrey Brown PhD; Associate Professor, Department of Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School
Patrizia A. Cavazzoni MD; Worldwide Development Operations, Pfizer, Inc.
Francesca Cunningham PharmD; Center for Medication Safety, U.S. Department of Veterans Affairs
Gerald J. Dal Pan MD, MHS; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Bruce Fireman ; Division of Research, Kaiser Permanente Northern California
Susan Hariri PhD; Division of Viral Hepatitis, U.S. Centers for Disease Control and Prevention
Troy McCall PhD; Chief Implementation Officer, Reagan-Udall Foundation for the FDA
Catherine M. Meyers MD; Office of Clinical and Regulatory Affairs, National Center for Complementary and Integrative Health, National Institutes of Health
Mikita J. Stephen JD; Planning Board Member, Sentinel, Lead, Sentinel Engagement Partners Workgroup, Patient Representative, Duke Clinical Trials Transformation Initiative;
Gregroy Pappas MD, PhD; National Device Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration
Doris Peter PhD; Health Ratings Center, Consumer Reports
Richard Platt MD, MSc; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School
Marsha E. Reichman PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Melissa Robb ; Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Joe Selby MD, MPH; Patient-Centered Outcomes Research Institute;
Azadeh Shoaibi PhD, MHS; Sentinel Lead, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
Paul Wallace MD; Optum Labs
Janet Woodcock MD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration