Biostatistical considerations when using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment

Mark Levenson,Weili He,Jie Chen,Yixin Fang,Douglas Faries,Benjamin A. Goldstein,Martin Ho,Kwan Lee,Pallavi Mishra-Kalyani,Frank Rockhold,Hongwei Wang,Richard C. Zink

Statistics in Biopharmaceutical Research（2021）

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摘要

Real-world evidence (RWE), derived from Data from “real-world” clinical practice and medical product utilization, is an increasingly important source of evidence that holds great potential to incre...

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Development,Medical product,Regulatory

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