FDA’s Sentinel System Harnesses Big Data to Monitor Medical Products

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The Food and Drug Administration’s Sentinel initiative for monitoring the safety of FDA-regulated drugs and other medical products is one of the largest uses of big data in healthcare, according to the regulatory agency’s outgoing commissioner Margaret Hamburg, M.D.

The active surveillance system, which recently transitioned from a five-year pilot program to a full-scale system, has established secure access to the healthcare data of more than 170 million patients across the country, including claims data and electronic health records. FDA is currently querying large, diverse health care data for product safety through Sentinel and exploring opportunities to expand the use of real-world observational data to optimize the performance of medical products.

“Real-world data provides a vital tool to monitor medical products in use in the marketplace,” Hamburg testified March 10 before a Senate Health, Education, Labor, and Pensions Committee hearing on “Continuing America’s Leadership in Medical Innovation for Patients.”

Large U.S. healthcare organizations, including Aetna, Humana and Kaiser Permanente, have served as data partners for Sentinel, enabling researchers to evaluate valuable safety information on drugs and vaccines while protecting the identity of individual patients.

“With appropriate privacy protections, leveraging large databases containing patient EHR, disease registry and claims data has resulted in significant advances in our understanding of health and disease, provided novel and sometimes surprising insights into potential relationships between health-related factors and outcomes, and provided important product safety data,” according to Hamburg.

However, she warned that the “science of using big data to establish product effectiveness is still in its infancy” and that “real progress demands that we develop the methodologies needed to harness the promise of real-world data.”

Hamburg, who has led the FDA for almost six years, is leaving the agency at the end of this month.



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