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VUMC tapped for FDA drug and medical device monitoring

Oct. 23, 2014, 10:13 AM

Vanderbilt University Medical Center is among a handful of organizations engaged to provide expertise and data to the Sentinel System, a U.S. Food and Drug Administration program designed to monitor the safety of drugs and medical devices that have reached market.

Sentinel uses electronic health records and health care billing data to examine how patients fare when exposed to drugs and medical devices. This month the FDA announced $150 million in funding for the program.

“Vanderbilt was a very competitive site to be included in this initiative because of our expertise and leadership in pharmacoepidemiologic research and our access to data sources to contribute to this effort,” said the principal investigator for Vanderbilt’s participation in Sentinel, Marie Griffin, M.D., MPH, professor of Health Policy and Medicine.

Griffin said VUMC will receive around $250,000 per year from the FDA to help cover drug and device safety surveillance infrastructure costs. Vanderbilt will also receive additional support as it undertakes specific studies for Sentinel.

Sentinel seeks only aggregate patient data from its data partners, and any Sentinel safety surveillance conducted by Vanderbilt occurs behind the University’s information firewall.

Griffin succeeds William Cooper, M.D., MPH, Cornelius Vanderbilt Professor of Pediatrics and professor of Health Policy, who led Vanderbilt’s participation in Mini-Sentinel, the FDA’s recently completed five-year, $120 million pilot program for safety surveillance.

Under Mini-Sentinel, “We’ve participated in studies evaluating the risk of acute kidney injury and acute myocardial infarction related to medication exposures, blood clots related to immunoglobulin use, and adverse effects of HPV vaccine administration, among other projects. Vanderbilt investigators have also played a role in the technical advisory group and the planning board,” Cooper said.

Others at Vanderbilt who have contributed to the safety initiative include faculty members Wayne Ray, Ph.D., Melissa McPheeters, Ph.D., MPH, and Frank Harrell Jr., Ph.D., and staff members Tony Morrow and Judy Dudley.

Other academic centers engaged by Sentinel include Harvard, Duke, Columbia, Penn, Cornell, Rutgers, the University of Iowa, the University of Alabama and the University of Illinois at Chicago. A number of insurance companies and safety organizations also contribute data and expertise.

“Although Vanderbilt investigators continue to perform many studies using single databases, there are distinct advantages to working with multiple data partners,” Griffin said, adding that about 150 investigators are active in the Sentinel System, with almost 50 million people currently enrolled who continue to contribute data.

“These numbers allow for analyses with much greater precision,” she said.

For more information visit the Sentinel website at http://mini-sentinel.org.

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