FDA post-market surveillance system enters next phase

A national system that uses electronic healthcare data to monitor the safety of FDA-regulated drugs and medical products is being enhanced to increase its efficiency and responsiveness.

Sentinel, developed and operated by Harvard Pilgrim Health Care Institute since 2009, is the FDA’s flagship active surveillance system and is the world’s largest multisite distributed database dedicated to medical product safety.

“The FDA plans to continue to advance major initiatives introduced in recent years (e.g., signal identification, use of advanced analytics, real-world evidence demonstration projects) over the next five years, with a more concentrated effort on exploring novel ways to extract and structure information from electronic health records in the future,” according to the regulatory agency.

Under a five-year contract worth $220 million, Harvard Pilgrim Health Care Institute will continue to run the Sentinel Operations Center and to create two new coordinating centers—the Sentinel Innovation Center and the Community Building and Outreach Center—to better leverage clinical data for detecting potential safety problems.

The Innovation Center, led by Harvard Pilgrim Health Care Institute, will develop innovative methods to further advance Sentinel, including exploring novel ways to extract and structure information from EHRs. The Community Building and Outreach Center, led by Deloitte Consulting, will focus on communication and collaboration, as well as deepening stakeholder involvement and broadening awareness, access, and use of Sentinel tools and data infrastructure.

“These new centers will work with the Sentinel Operations Center to develop new technologies and enable stakeholders to grow the Sentinel system into a vigorous scientific community,” says Gerald Dal Pan, director of the Office of Surveillance and Epidemiology in the FDA’s Center for Drug Evaluation and Research. “Sentinel has always sought to be a national resource, and this new structure strengthens our abilities to achieve this goal and ultimately improve the safety and effectiveness of medicines for American patients.”

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Vanderbilt University Medical Center will co-lead the Sentinel Innovation Center with Brigham and Women’s Hospital, Duke Clinical Research Institute and Kaiser Permanente Washington Health Research Institute.

“While Sentinel has had marked success relying primarily on structured administrative and billing data from healthcare payers, the goal all along has been to expand safety surveillance into the realm of de-identified electronic health records, where some of the richest information is stored as text,” says Michael Matheny, MD, associate professor of biomedical informatics, biostatistics and medicine and co-director of the VUMC Center for Improving the Public’s Health Through Informatics.

Matheny adds that the Sentinel Innovation Center will support the “development of new tools to efficiently unlock the safety information in these records—tools in areas like natural language processing, machine learning and safety signal detection.”

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