Using and improving distributed data networks to generate actionable evidence: the case of real-world outcomes in the Food and Drug Administration's Sentinel system.
The US Food and Drug Administration (FDA) Sentinel System uses a distributed data network, a common data model, curated real-world data, and distributed analytic tools to generate evidence for FDA decision-making. Sentinel system needs include analytic flexibility, transparency, and reproducibility while protecting patient privacy. Based on over a decade of experience, a critical system limitation is the inability to identify enough medical conditions of interest in observational data to a [...]
Author(s): Brown, Jeffrey S, Maro, Judith C, Nguyen, Michael, Ball, Robert
DOI: 10.1093/jamia/ocaa028