FDA In Brief: FDA announces a new Sentinel System contract, affirming its commitment to harnessing Real-World Data to improve the safety and effectiveness of drugs

FDA In Brief: FDA announces a new Sentinel System contract, affirming its commitment to harnessing Real-World Data to improve the safety and effectiveness of drugs

Today, the U.S. Food and Drug Administration is announcing an award granting a new five-year contract for the Sentinel System, the FDA’s flagship active surveillance system. The new contract was awarded to two consortiums led by Harvard Pilgrim Health Care and Deloitte Consulting, which will establish three distinct coordinating centers (the Sentinel Operations Center, Innovation Center and the Community Building and Outreach Center) to widen participation to a broader array of scientific expertise, translate new technologies from emerging fields such as data science and big data, create laboratories to develop new approaches to using electronic health records and cultivate a robust scientific community to uncover novel ways to leverage the system’s core capabilities beyond drug safety. This is the third five-year contract awarded since Sentinel was established. The new contract retains and builds upon the core innovations that were responsible for many of the achievements in the prior decade: the participation of data partners who bring their knowledge and expertise to the Sentinel network, the re-useable analytic tools that run against data formatted in the...

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