Tech & Health

October 16, 2019

VUMC assumes new role in FDA safety monitoring

Vanderbilt University Medical Center is assuming an expanded role in U.S. Food and Drug Administration (FDA) medical product safety monitoring.


by Paul Govern

Vanderbilt University Medical Center is assuming an expanded role in U.S. Food and Drug Administration (FDA) medical product safety monitoring.

Through a program called Sentinel, developed and operated for the FDA by Boston-based Harvard Pilgrim Health Care Institute, the federal government supports national electronic safety surveillance of regulated medical products after they’ve reached market — drugs, medical devices, vaccines, blood products, other biologicals, etc. According to the FDA, Sentinel is the largest multisite distributed database in the world dedicated to medical product safety. VUMC has collaborated in this effort since it was launched in 2009.

On Sept. 27, the FDA announced five years’ additional funding for Sentinel and a new arm of the program, the Innovation Center, designed to advance the use of electronic health records and publicly available data sources for medical product safety surveillance. Harvard Pilgrim will lead the new Innovation Center and will continue to lead Sentinel’s previously established Operations Center.

VUMC’s Department of Biomedical Informatics will serve as one of four co-leads of the Innovation Center, together with groups from Brigham and Women’s Hospital in Boston, Duke Clinical Research Institute in Durham, North Carolina, and Kaiser Permanente Washington Health Research Institute in Seattle. Similar in size to the Operations Center, the Innovation Center comprises a diverse group of more than 50 academic centers and health care payers.

Joining the executive committee of the Innovation Center are VUMC faculty members Kevin Johnson, MD, MS, Cornelius Vanderbilt Chair in Biomedical Informatics, professor of Pediatrics and Informatician-in-Chief at VUMC, and Michael Matheny, MD, MS, MPH, associate professor of Biomedical Informatics, Biostatistics and Medicine and co-director of the recently announced VUMC Center for Improving the Public’s Health Through Informatics.

“While Sentinel has had marked success relying primarily on structured administrative and billing data from health care 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,” Matheny said.

“The Innovation Center will support VUMC and its other member organizations in 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. As members of the executive committee, Kevin and I will help direct this expansion of Sentinel’s capabilities,” he said.

VUMC’s Department of Health Policy, using data from Tennessee’s Medicaid program, TennCare, is one of several academic groups that collaborate on an ongoing basis in Sentinel. Marie Griffin, MD, MPH, professor of Health Policy and Medicine and holder of the Directorship in Public Health Research and Education, serves as principal investigator for VUMC studies funded by the Sentinel Operations Center.

“More than 70 million patients are currently accruing data within the distributed database supported by Sentinel. For safety surveillance the advantages to working at this scale with multiple data partners are invaluable. The five-year funding renewal for Sentinel is very welcome news,” Griffin said.

Going forward, safety surveillance infrastructure support for VUMC from Sentinel will increase to around $350,000 annually, spread between the departments of Health Policy and Biomedical Informatics. Beyond this support, additional funding for Sentinel’s member organizations is available as they conduct special projects for the collaborative.