Over the past decade, the U.S. Food and Drug Administration (FDA) has amassed a wealth of health care data through its Sentinel Initiative, an electronic data system used to monitor FDA-regulated drugs, medical devices and other products.
In September 2019, the FDA announced the addition of two new Sentinel coordinating centers, one of which is the Sentinel Innovation Center whose charge is to better regulate drugs and keep patients safe by developing new technologies and approaches to convert data into actionable knowledge.
Several faculty and alumni from the University of Washington Department of Biostatistics and School of Public Health serve in leadership roles for these projects. Jennifer Nelson, who is director of biostatistics at Kaiser Permanente Washington Health Research Institute (KPWHRI), an affiliate professor of biostatistics at the UW, and a program alumni (PhD ’99), is one of these experts.
Nelson remarks, “Sentinel has only begun to tap the incredible richness of information that exists in electronic health records (EHR).” Nelson is a member of the Innovation Center’s Executive Leadership team along with Patrick Heagerty, a professor of biostatistics at the University of Washington, and director of the Center for Biomedical Statistics.
“Right now using Sentinel, the FDA can monitor some new medical products for some potential adverse events and get some answers more quickly than before. A successful Sentinel Innovation Center will allow FDA to go from some to many; to scale up and do much more comprehensive, high quality, and rapid safety surveillance on a routine basis simultaneously for a broader range of potential adverse events and drugs.”
Nelson cites anaphylaxis as an example of the limitations of using current “tip-of-the-iceberg” data. Existing EHR data algorithms for some serious conditions like anaphylaxis are not captured accurately enough for robust use by Sentinel.
“We need both innovative technologies to better leverage additional data elements and scalable analytics to process large amounts of information across a distributed network,” says Nelson. “The FDA would like to use the Innovation Center as the place to incubate and test newer and more advanced approaches and then take the methodologic success stories and incorporate them into Sentinel’s semi-automated data query/analysis systems and routine practice.”
To help achieve this, the Innovation Center will engage partners outside traditional drug safety disciplines like medical informatics and data science.
“What excites me is the opportunity to forge stronger collaboration outside academia with tech companies like Microsoft and Amazon. I get the chance to connect leading scientists to a major public health initiative where their state-of-the-art expertise can make a direct and positive impact on patient safety in the US,” says Nelson.
Nelson has been involved with the Sentinel Initiative since 2008 and has led and collaborated on a number of projects. Other Innovation Center researchers with UW Biostatistics ties include Analytics Core leads Andrea Cook, affiliate professor of biostatistics and senior investigator with KPWHRI, and Biostatistics alumnus Xu Shi, PhD ’17, now an assistant professor of biostatistics at Michigan. Additional UW representatives are Bruce Psaty (Medicine, Epidemiology—also of KPWHRI); Susan Heckbert (Epidemiology, Pharmacy), and James Floyd (Medicine).
The Innovation Center operates under the auspices of Harvard Pilgrim Health Care where it is led by Sebastian Schneeweiss of Brigham and Women’s Hospital, Harvard Medical School. In addition to UW and Kaiser, co-leaders include investigators from the Duke Clinical Research Institute and the Vanderbilt University Medical Center Department of Biomedical Informatics.
Deb Nelson, Biostatistics communications and event manager