In cooperative agreement with the U.S. Food and Drug Administration (FDA), the Robert J. Margolis, MD, Center for Health Policy convened a public webinar on planned next steps to advance FDA’s Sentinel System.
In May 2018, the Duke-Margolis Center for Health Policy convened a private workshop, also under a cooperative agreement with FDA, to explore opportunities for addressing Active Post-Market Risk Identification System (ARIA) sufficiency gaps that are barriers to outcome validation. Workshop discussion explored how innovative technologies such as natural language processing, machine learning, and electronic phenotyping could support more streamlined and automated validation processes.
Building on the expert workshop, this public webinar featured key leaders of the Sentinel System who provided insight into the specific challenges surrounding ARIA insufficiency, and highlighted key approaches being explored in collaboration with the Sentinel Data Partners to improve outcome validation activities. Supporting slides from the presentation are available below.
View the event page here.
Gregory Daniel, Duke-Robert J. Margolis, MD, Center for Health Policy
Robert Ball, U.S. Food and Drug Administration
Jeffrey Brown, Harvard Medical School & Harvard Pilgrim Health Care Institute