Harvard Pilgrim Health Care Institute Secures $220M to Operate and Extend the FDA’s Sentinel System for Safety Monitoring

Oct 19, 2019 | FDA, Real-world data, Real-World Evidence, RWD, RWE, Safety Data, Safety Monitoring, The Sentinel System

Harvard Pilgrim Health Care Institute Secures $220M to Operate and Extend the FDA’s Sentinel System for Safety Monitoring

The U.S. Food and Drug Administration (FDA) has awarded a contract that could reach $220 million over the next five years to the Harvard Pilgrim Health Care Institute (HPHCI) to continue to lead the Sentinel Operations Center and to develop a new Sentinel Innovation Center. This contract is an add-on to the existing Sentinel partnership with HPHCI. Sentinel is a national program utilizing electronic health care data to monitor the safety of FDA-regulated drugs and other medical products. Sentinel is also now the basis of RWD-based studies.

For some context, TrialSite News includes a link to Sentinel System background information. 

FDA Seeks to Keep and Expand Sentinel System

This recent contract signals the FDA’s commitment to leverage the existing Sentinel System investments to further its mission to ensure patient safety with drugs and devices. The funding calls for the “Sentinel Innovation Center” which will be led by Sebastian Schneeweiss, MD, ScD of Brigham and Women’s Division of Pharmacoepidemiology and Pharmacoeconomics.


HPHCI will seek to partner with over 60 technology, health care, and academic organizations across the nation on this important undertaking. Just recently they announced a partnership with TriNetX

HPHCI Partnered with the FDA since the Beginning

HPHCI or “the Institute” has led the Sentinel System since its inception in 2009. They created a national electronic system for monitoring the performance of FDA-regulated medical products. Using the national data network, FDA regularly conducts safety analyses of the billions of hospital stays, outpatient visits, and pharmaceutical dispensing.

Future Plans with Funding

HPHIC and FDA seek to enhance and extend the efficiency and responsiveness of the Sentinel System by developing new data sources and more sophisticated methods of broadening the community of users as well as invite additional partners to further enhance the expertise of the center.

Sentinel System being used for Real-World Evidence Clinical Trials

The Clinical Trials Transformation Initiative (CTTI) has worked on the Sentinel System first collaborating on the “Mini-Sentinel” system. During the Mini-Sentinel pilot project, CTTI partnered with FDA and the HPHCI to assess the feasibility of using this distributed database to conduct clinical trials. The results indicated that most participating health plans have considerable and relevant experience to use the resources created by the pilot project to conduct randomized trials.

Current Real-World Evidence-based Trial using Sentinel System

CTTI is collaborating with HPHCI on a “follow-on project:” The Implementation of a Multicenter Clustered Randomized Controlled Trial to Improve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). The successful launch of this study, randomizing over 80,000 patients and their providers, reflects the accomplishment of the first trial conducted using a decentralized database of claims data.

Who is HPHCI

The Harvard Pilgrim Health Care Institute’s Department of Population Medicine is a unique collaboration between Harvard Pilgrim Health Care and Harvard Medical School. Created in 1992, it was the first appointing medical school department in the United States based on a health plan.

Call to Action: If you are interested in engaging with HPHCI Richard Platt, MD, MSc, Professor, and Chair of the Department of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School and Principal Investigator of the FDA Sentinel System. Also, see Sentinel’s website.


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