Public health surveillance using distributed data networks: Lessons from FDA’s Sentinel Initiative and the Canadian Network for Observational Drug Effect Studies

Public health surveillance using distributed data networks: Lessons from FDA’s Sentinel Initiative and the Canadian Network for Observational Drug Effect Studies

Workshop ChairsNoelle Cocoros and Sean Hennessy
Additional Faculty: Candace Fuller, Alison Kawai, Kristian Filion

Large distributed database networks (DDNs) such as that used by the US FDA’s Sentinel System present unparalleled public health surveillance opportunities, but also pose unique epidemiologic challenges. For example, while privacy/confidentiality concerns can be managed by electronic healthcare data residing behind data partner firewalls, this approach necessitates innovations such as a common data model and reusable analytic tools that execute epidemiologic studies in distributed data. In this workshop we will: discuss the rationale for and architecture of Sentinel’s DDN; describe how epidemiologic studies are implemented in this environment using privacy-preserving approaches; present results of a recent Sentinel vaccine safety study; and compare Sentinel with the Canadian Network for Observational Drug Effect Studies. The target audience is epidemiologists interested in DDNs, multi-center research networks, advanced methods in observational research, and medical product safety surveillance.