Implementation of Signal Detection Capabilities in the Sentinel System 

On December 3, 2018, in cooperative agreement with the U.S. Food and Drug Administration (FDA), the Robert J. Margolis, MD, Center for Health Policy at Duke University will convene a public workshop to explore opportunities to implement signal detection capabilities in the Sentinel System. Authorized in 2007 by the Food and Drug Administration Amendments Act (FDAAA), the Sentinel System is an active and fully functioning postmarket safety surveillance system that can rapidly scale distributed analyses on data collected by a diverse range of Sentinel Data Partners to identify potential safety risks related to the use of prescription drugs. To continue advancing and modernizing this data infrastructure, the Agency is seeking broad stakeholder input on the landscape of methodological approaches for signal detection, as well as the opportunities and challenges to implement these approaches in Sentinel’s distributed data network. Discussion will also consider key governance and operational needs for implementing signal detection tools in a hypothesis free environment. Stakeholder input received at this workshop will further inform the Agency’s thinking around these priority issues and support strategic planning in the Sentinel System.