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COVID-19 Real-World Evidence Primer

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    To learn from the evolving lessons of addressing the COVID-19 pandemic and to bolster the future use of real-world data (RWD) and real-world evidence (RWE), the Reagan-Udall Foundation for the Food and Drug Administration, in collaboration with the International Society for Pharmacoepidemiology, created The COVID-19 Real-World Evidence Primer. The Primer consists of seven chapters that cover types of RWD, methods in RWE generation, examples of RWE studies and initiatives, and strategies for communicating about RWE. Chapter five of the document, Major Multi-Stakeholder Initiatives — Defining the Future of COVID-19 Observational Research, highlights Sentinel as one of six COVID-19 RWD multi-stakeholder initiatives serving as illustrative examples that may help us understand the future of COVID-19 research—and the future of RWD and RWE.