FDA commits up to $220 million for next phase of drug-safety monitoring system

The funding for the Sentinel Initiative includes establishing an innovation center, to be led by Harvard Pilgrim in partnership with KPWHRI and others

The U.S. Food and Drug Administration has awarded a contract that may reach $220 million over the next five years to enable its Sentinel System to better harness electronic health care data to monitor the safety of FDA-regulated drugs, devices, and other medical products after they are on the market.

This next phase of the Sentinel initiative will be led by the Harvard Pilgrim Health Care Institute in collaboration with investigators from Kaiser Permanente Washington Health Research Institute (KPWHRI), University of Washington School of Public Health (UWSPH), the Duke Clinical Research Institute, and the Vanderbilt University Medical Center Department of Biomedical Informatics, among others.

The funding will continue support of the Sentinel Operations Center and launch a new innovation center that will bring together more than 60 collaborators, including technology, health care, and academic organizations from across the nation.

“Sentinel has only begun to tap the incredible richness of information that exists in electronic health records (EHR),” said Jennifer Clark Nelson, PhD, head of KWHRI biostatistics and a member of the Innovation Center’s Executive Leadership team, in a recent story by UWSPH, where she is also an affiliate professor.

She added: “Right now using Sentinel, the FDA can monitor some new medical products for some potential adverse events and get some answers more quickly than before. A successful Sentinel Innovation Center will allow FDA to go from some to many; to scale up and do much more comprehensive, high-quality, and rapid safety surveillance on a routine basis simultaneously for a broader range of potential adverse events and drugs.”

The new Sentinel Innovation Center will be led by Sebastian Schneeweiss, MD, ScD, of Brigham and Women’s Division of Pharmacoepidemiology and Pharmacoeconomics, and co-led by investigators from the Duke Clinical Research Institute and the Vanderbilt University Medical Center Department of Biomedical Informatics as well as KPWHRI and UWSPH.

The 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 with support from KPWHRI and other research centers. Using this national data network, FDA regularly conducts safety analyses of billions of hospital stays, outpatient visits, and pharmaceutical dispensings. 

“We are very pleased to continue leading the Sentinel System along with our collaborating partners,” said 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.  The program now regularly informs FDA’s guidance to physicians and the public about the safety and safe use of medical products. 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” adds Dr. Platt. 

Plans for the next phase of the Sentinel project enhancements aim 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.

This story is adapted from the news release posted by Harvard Pilgrim Health Care Institute's Department of Population Medicine. Information was added from a story about the Sentinel Initiative on the UWSPH Department of Biostatistics website.