Abstract:
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A Real-World Evidence (RWE) scientific working group of the American Statistical Association Biopharmaceutical Section has been reviewing the statistical considerations for the generation of real-world evidence to support regulatory decision making. As part of the effort, the working group is addressing the fitness-for-use of real-world data (RWD). RWD may be used in a variety of ways and study designs including in randomized studies, externally controlled studies, and purely observational studies. The use of RWD poses unique issues surrounding study integrity, transparency, and reproducibility. The working group proposes a data-driven approach framework for determining the fit-for-use of RWD.
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