In cooperative agreement with the U.S. Food and Drug Administration (FDA), The Robert J. Margolis, MD, Center for Health Policy is convening a public webinar on planned next steps to advance FDA’s Sentinel System.
The Sentinel System, authorized in 2007 by The Food and Drug Administration Amendments Act (FDAAA), is an active and fully functioning post market surveillance system that can rapidly scale distributed analyses on data collected by a diverse range of Sentinel Data Partners. The Active Post-Market Risk Identification System (ARIA), a key component of the Sentinel System, represents a set of querying tools combined with electronic health care data in the Sentinel common data model to conduct safety assessments on pharmaceutical products. FDA is routinely using ARIA to inform a variety of regulatory actions including label changes, Advisory Committee deliberations, and other important safety assessment decisions.
By law, before using ARIA, the FDA must first determine whether the data and methods available are “sufficient” to answer regulatory questions of interest. The FDA currently defines sufficient in terms of the availability of adequate data (e.g. the drug or biologic of interest, comparators, confounders, and covariates) and appropriate tools to provide a satisfactory level of precision. While ARIA has been successfully used to inform regulatory decisions, there are instances when the infrastructure is deemed insufficient. Preliminary agency analyses have identified outcome validation as a major contributing factor of ARIA insufficiency.
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 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 will feature key leaders of the Sentinel System who will provide insight into the specific challenges surrounding ARIA insufficiency, and highlight key approaches being explored in collaboration with the Sentinel Data Partners to improve outcome validation activities.
Funding for this webinar was made possible in part by a cooperative agreement from the U.S. Food and Drug Administration Center for Drug Evaluation and Research. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.