Looking at the Sentinel

FDA has announced the 12th Annual FDA Sentinel Public Workshop on April 20-21, 2020. (Please go here for the details.)  The Sentinel System is the largest multi site patient safety database in the world, and includes the Active Post-marketing Risk Identification and Analysis (ARIA) system mandated by Congress in the US Food and Drug Administration (FDA) Amendments Act (FDAAA) of 2007.  In May 2008, the FDA launched the Sentinel Initiative to create a national electronic system for medical product safety surveillance.  The full Sentinel system was launched in February 2016.  It is a system that actively monitors FDA-regulated products using state of the art techniques to enhance public safety.  FDA’s strategic plan for the Sentinel System reflects several Agency objectives which include acceleration of use of the system within FDA to support the regulatory decision-making process, explore the utility of real-world data as a tool to support drug development and assess medical product performance, facilitate response to legislative mandates regarding medical product safety and effectiveness evaluation, expand the system by facilitating its use by other stakeholders to foster innovation and development.  Check the “Sentinel System Five-Year Strategy: 2019-2023” (here) for details.  A snapshot of the Sentinel Database Statistics (here) shows, in addition to other information, that 70.1 million members are currently accruing new data and there are 310.8 million cumulative patient identifiers between 2000 and 2018.  Pretty impressive amount of information.

The two-day workshop will discuss the recent progress of Sentinel, include sessions related to strategic initiatives,   how existing data can be used effectively, and also the methods and data that are needed to support analytical techniques.  Without going into the nuts and bolts of how the system operates, our humble hope is that Sentinel provides FDA with helpful tools to make better decisions related to drugs, and continues to help develop innovative approaches to enhance FDA’s safety surveillance capabilities and also help the industry effectively use real world data in drug development.  After all, at the end of the day, we would all want to be assured that all the information collected by Sentinel is translated to actionable knowledge that helps the pharmaceutical industry and the American public.