The Food and Drug Administration’s (FDA’s) Sentinel Initiative is designed to use real-world evidence to evaluate the safety and performance of medical products, including drugs, vaccines, biologics, and medical devices. Operating under a distributed data model, Sentinel coordinates large-scale pharmacoepidemiologic surveillance studies across multiple data partners (e.g., insurance companies, health systems and academic medical centers), allowing all data to remain in the hands of the data owner. The program began as a pilot in 2007, and after many years of development, fully launched as the Sentinel Initiative in 2016.
The Department of Health Policy participates as one of over a dozen active data partners in this program. Department efforts are led by site-PI Research Associate Professor Dr. Margaret Adgent, PhD, Research Associate Professor Christine Whitmore, PhD, and Professor Carlos Grijalva, MD, MPH, with technical and administrative support from database administrators Tony Morrow and Jean Bruce and research coordinator Judy King.
This team applies the department’s existing data platform of linked TennCare and vital records (curated within the Health Policy Data Core) to the Sentinel Common Data Model which allows the FDA to answer important public health questions without personal or protected health information being shared.
Data tables populated in this model include Medicaid enrollment, demographics, pharmacy dispensing, diagnosis and procedures, and death (including cause of death). In addition, due to the high quality and complexity of the linked TennCare data, Health Policy’s site is one of only a few Sentinel data partners able to maintain a mother-child link, addressing a crucial need for the study of drug safety during pregnancy.