September 27, 2019
“The Sentinel System is one of the FDA’s premier evidence-generation platforms and has become a core feature of the agency’s postmarket safety system, providing important new safety information to inform regulatory decision making and ensuring that the medicines patients receive are safe and effective. Through this system, we’ve been able to study safety issues that would otherwise have required additional time and effort through industry-required postmarket studies. Sentinel has also been instrumental in advancing the FDA’s Real-World Evidence program through the FDA Catalyst program,” said Gerald Dal Pan, director of the Office of Surveillance and Epidemiology in the FDA’s Center for Drug Evaluation and Research. “The new five-year Sentinel contract we’re announcing today builds upon these successes by creating two new Sentinel Coordinating Centers: the Sentinel Innovation Center and the Community Building and Outreach Center. 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. 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.”
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 Sentinel Common Data Model, the multifaceted data quality and curation process and the ability to trace important clinical information back to the medical record.
The first year of the contract will focus on standing up each new coordinating center, establishing new policies and processes to coordinate the different entities, and developing a scientific blueprint for the next five years. 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. Through the expansion of the Sentinel program and deeper engagement with the scientific community, the FDA hopes to continue to strengthen the system and increase its public health impact.
- Sentinel Five Year Strategy, January 2019
- Framework for FDA’s Real-World Evidence Program
- Real-Word Evidence and Real-Word Data for Evaluating Drug Safety and Effectiveness
- Real‐World Data, Advanced Analytics, and the Evolution of Postmarket Drug Safety Surveillance
- Sentinel Initiative 2019 Solicitation
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.