Keeping Watch

Harvard Pilgrim Health Care Institute funded for next phase of FDA Sentinel System

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The U.S. Food and Drug Administration has awarded a contract that may reach $220 million over the next five years to the Harvard Pilgrim Health Care Institute to continue to lead the Sentinel Operations Center and to develop a new Sentinel Innovation Center.

This contract builds on Harvard Pilgrim Health Care Institute’s 10 years of experience developing and operating the Sentinel System, a national program that uses electronic health care data to monitor the safety of FDA-regulated drugs and other medical products. 

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The addition of the Sentinel Innovation Center signals the FDA’s commitment to keeping the Sentinel System a robust and cutting-edge national resource. The Institute will partner with over 60 technology, health care and academic organizations across the nation on this important undertaking.

The Innovations Center will be led by Sebastian Schneeweiss, HMS professor of medicine at Brigham and Women’s Hospital in the Division of Pharmacoepidemiology and Pharmacoeconomics, and co-led by investigators from the Duke Clinical Research Institute, Kaiser Permanente Washington Health Research Institute together with the University of Washington School of Public Health, and the Vanderbilt University Medical Center Department of Biomedical Informatics.

Harvard Pilgrim Health Care Institute has led the Sentinel System since its inception in 2009, creating a national, electronic system for monitoring the performance of FDA-regulated medical products. Using this national data network, the FDA regularly conducts safety analyses of the billions of hospital stays, outpatient visits and pharmaceutical dispensings.

“We are very pleased to continue leading the Sentinel System along with our collaborating partners. The program now regularly informs the FDA’s guidance to physicians and the public about the safety and safe use of medical products,” said Richard Platt, HMS professor of population medicine and chair of the Department of Population Medicine at Harvard Pilgrim Health Care Institute and principal investigator of the FDA Sentinel System.

Such post-marketing studies typically require years to design and complete, each at a cost of millions of dollars.

“We look forward to continuing these efforts and enabling Sentinel to grow in scope and scale over the next five years,” Platt said. 

Plans for the next phase of the Sentinel project include enhancements to increase efficiency and responsiveness, to develop new data sources and more sophisticated methods, to broaden the community of users, and to enhance the Center’s extensive expertise by bringing on additional specialized collaborators, project leaders said.

The Department of Population Medicine is a unique research and academic partnership between Harvard Pilgrim Health Care Institute and Harvard Medical School. The department, formerly the Department of Ambulatory Care and Prevention, was created in 1992 to focus on research and education as they relate to the care of large, defined populations. It is the nation’s only medical school appointing department that sits in a health plan. Since 2009, the department has been housed in the Harvard Pilgrim Health Care Institute, a limited liability corporation that includes the Department of Population Medicine and the Harvard University Office of Sponsored Programs.

This story was adapted from a Department of Population Medicine news release.