To learn from the evolving lessons of addressing the COVID-19 pandemic and to bolster the future use of real-world evidence, the Reagan-Udall Foundation for the FDA created this COVID-19 Real-World Evidence Primer to describe the real-world data ecosystem. Included are key principles of study design and potential sources of bias, examples of COVID-19 studies that use real-world data, and mechanisms for disseminating real-world evidence gleaned from the conduct of real-world data research.

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