“… Sentinel now proactively monitors medical product safety, provides a critical engine for methodological innovation, and serves as a platform to advance the science of realworld evidence. Fully implemented in 2016, the Sentinel System is now a core feature of FDA’s post-market safety surveillance armamentarium and a vital testbed for advanced technologies and approaches. Recognizing the need to shape the Sentinel System’s development for a changing drug development and safety ecosystem, FDA proposes the following five-year strategy and road map.”
“In the next five years, FDA will focus its investment on innovations emerging from new data science disciplines, such as natural language processing and machine learning, and seek to expand its access to and use of electronic health records (EHRs). FDA will balance this forward-looking strategy by incorporating core gains from the prior decade that witnessed the creation of the largest and most advanced medical product safety surveillance system to date that includes the Sentinel Common Data Model, a quality-checked distributed network, and suite of state-of-the-art analysis tools. The strategy directs Sentinel to reach beyond its current boundaries while preserving capabilities and key accomplishments. By 2023, FDA envisions a more robust Sentinel System: a transformative, multi-purpose national data and scientific resource center for evidence generation that a wide array of stakeholders use to inform all aspects of healthcare decision making…” Read the full report here.
Source: Sentinel Systems – Five Year Strategy – FDA.