June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)
Rethinking Clinical Trials
JUNE 29, 2022
Real-world data (RWD) is a term with specific regulatory implications referring to health care data routinely collected from a variety of sources. Real-world evidence (RWE) is clinical evidence derived from analysis of RWD regardless of study design. and the FDA Draft Guidance for RWD/RWE. pctGR, @Collaboratory1.
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