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FDA's Sentinel Initiative

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Transforming how we monitor the safety 
of FDA-regulated products

Sentinel Initiative

Monitoring the safety of its regulated products is a major part of the FDA’s mission to protect public health. Sentinel is the FDA’s national electronic system which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices. In response to the FDA Amendments Act (FDAAA) of 2007, in May 2008 the FDA launched the Sentinel Initiative.

The first phase of this initiative was the Mini-Sentinel Pilot to inform the development of the Sentinel System. In September 2014, the FDA began transitioning from the Mini-Sentinel phase to the full Sentinel System, which officially launched in February 2016.  Over time, Sentinel has developed the largest multisite distributed database in the world dedicated to medical product safety. It is constantly growing and improving to meet FDA’s needs.

In September 2019, FDA announced Sentinel would expand to three distinct coordinating centers: Sentinel Operations Center, Innovation Center, and Community Building and Outreach Center.  The Operations Center will continue to leverage organizational partnerships in the areas of epidemiology, clinical medicine, pharmacy, statistics, health informatics, data science (specifically, artificial intelligence (natural language processing, machine learning)), and network operations to support postmarket safety analyses.  The Innovation Center will develop innovative methods to further advance Sentinel, including exploring novel ways to extract and structure information from electronic health records in the future.  The Community Building and Outreach Center’s will focus on communication and collaboration as well as deepening stakeholder involvement and broadening awareness, access, and use of Sentinel tools and data infrastructure.

This new design will enhance participation to a wider array of scientific expertise, translate new technologies from emerging fields such as data science and big data, create laboratories to develop new approaches to using electronic health records, and cultivate a robust scientific community to uncover novel ways to leverage the system’s core capabilities beyond drug safety.

The Sentinel Collaborators

Center Collaborator

Sentinel Operations Center

  • Lead: Harvard Pilgrim Health Care Institute
  • Aetna, a CVS Health Company
  • Brigham and Women’s Hospital
  • Duke University School of Medicine: Department of Population Health Sciences (Medicare Fee-for-Service and Medicaid data)
  • Harvard School of Public Health
  • HCA Healthcare
  • HealthCore/Elevance Health
  • HealthPartners Institute
  • Humana, Inc.
  • Kaiser Permanente Colorado Institute for Health Research
  • Kaiser Permanente Hawaii Center for Integrated Health Care Research
  • Kaiser Foundation Health Plan of the Mid-Atlantic States, Inc.
  • Kaiser Permanente Northwest Center for Health Research
  • Kaiser Permanente Washington Health Research Institute
  • Marshfield Clinic Research Institute
  • Merative
  • Meyers Health Care Institute, a joint endeavor of UMass Chan Medical School, Reliant Medical Group, and Fallon Health
  • Optum (OptumInsight Life Sciences Inc. and Optum Labs)
  • Tennessee Medicaid 
  • TriNetX
  • University of Florida
  • University of Iowa
  • University of North Carolina
  • University of Pennsylvania School of Medicine: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology
  • Vanderbilt Medical Center, Department of Health Policy (Tennessee Medicaid data)

Sentinel Innovation Center

  • Lead Hubs
    • Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School
    • Duke University School of Medicine
    • Kaiser Permanente Washington Health Research Institute with the University of Washington School of Public Health
    • Vanderbilt University Medical Center Department of Biomedical Informatics
  • Aetna, a CVS Health company
  • Aetion, Inc.
  • Amazon Web Services
  • American Medical Informatics Association
  • Columbia University
  • ConcertoAI
  • CorEvitas
  • Doc.ai
  • Duke Margolis Center for Health Policy
  • Duke University
  • Epic
  • Evidation
  • Harvard T.H. Chan School of Public Health
  • HealthCore
  • HealthVerity
  • Humana, Inc.
  • Kaiser Permanente Colorado Institute for Health Research
  • Mass General Brigham
  • Medical University of South Carolina
  • Microsoft Healthcare NExT
  • Microsoft Research
  • Northeastern University
  • Oak Ridge National Laboratory
  • Observational Health Data Sciences and Informatics (OHDSI)
  • Optum Labs
  • Optum Life Sciences
  • Penn State University
  • Putnam Data Sciences
  • PRACnet (Humana)
  • Rutgers University: Center for Health Services Research
  • Stanford University
  • STAR Clinical Research Network
  • TriNetX
  • University of Alabama at Birmingham: Center for Outcomes and Effectiveness Research and Education
  • University of California, Berkeley
  • University of Illinois at Chicago: Department of Pharmacy Systems, Outcomes and Policy
  • University of Iowa: Department of Epidemiology in the College of Public Health
  • University of Florida College of Pharmacy: Department of Pharmaceutical Outcomes & Policy
  • University of Michigan Medical School
  • University of Pennsylvania School of Medicine: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics, Epidemiology and Informatics
  • University of Pittsburgh School of Medicine: Department of Biomedical Informatics
  • University of Tennessee
  • University of Utah
  • Veradigm

Sentinel Community Building and Outreach Center

  • Lead: Deloitte Consulting
  • Co-Lead: IQVIA
  • NOVA Research

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FDA In Brief

FDA announces a new Sentinel System contract, affirming its commitment to harnessing Real-World Data to improve the safety and effectiveness of drugs

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