After a five-year pilot program, the U.S. Food and Drug Administrations active surveillance system for monitoring the safety of FDA-regulated drugs and other medical products is finally transitioning to a full-scale system.
Launched in 2009, the FDAs Mini-Sentinel pilot program has established secure access to the electronic healthcare data of more than 178 million patients across the countryprincipally claims data but also electronic health recordsaccording to the regulatory agency. Building on this success, Mini-Sentinel has now morphed into the new full-scale Sentinel, envisioned by the FDA as a nationwide rapid-response electronic active surveillance system.
Writing in a Dec. 30 blog, Janet Woodcock, M.D., director of FDAs Center for Drug Evaluation and Research, describes Sentinel as a long journey toward the challenging goal of developing a full-scale medical product safety monitoring program. However, Mini-Sentinel has not been without its critics who argue that progress has been too slow and five years has been too long to wait.
We knew it would be years in the making, but Mini-Sentinels successful completion marks important progress, Woodcock asserts. We look forward to continuing and expanding our active surveillance capabilities as we now transition to the full-scale Sentinel program.
Eighteen large U.S. healthcare organizations, including Aetna, Humana and Kaiser Permanente, served as data partners for Mini-Sentinel, enabling researchers to evaluate valuable safety information on drugs and vaccines while protecting the identity of individual patients.
According to Woodcock, FDA will build on the success of the pilot program. Mini-Sentinel gave us an important start, but it is essential to continue to develop and refine existing scientific methods to evaluate the data we access through the Sentinel System, she says. We see Sentinel as a potentially valuable national resource for other safety researchers, besides those at FDA.
Looking even further ahead, our hope is that, working with other scientific groups, we will be able to create a National Data Infrastructure that would enable other users (e.g., other governmental agencies, researchers from academia or industry) to access the Sentinel infrastructure for multiple purposes (e.g., medical product research, quality improvement), Woodcock adds. Not only will such access directly serve the public health, it will also help sustain these programs because stakeholders will have an incentive to provide support (financial and otherwise) for its maintenance and growth.
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