Advancing the utilization of real-world data and real-world evidence in clinical pharmacology and translational research-Proceedings from the ASCPT 2023 preconference workshop

Jing Liu, Karen Rowland-Yeo,Almut Winterstein,Simon Dagenais, Qi Liu, Jeffrey S. Barrett,Rui Zhu, Cyrus Ghobadi,Amita Datta-Mannan,Joy Hsu,Sujatha Menon,Mariam Ahmed,Pooja Manchandani, Paulien Ravenstijn

CTS-CLINICAL AND TRANSLATIONAL SCIENCE(2024)

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摘要
Real-world data (RWD) and real-world evidence (RWE) are now being routinely used in epidemiology, clinical practice, and post-approval regulatory decisions. Despite the increasing utility of the methodology and new regulatory guidelines in recent years, there remains a lack of awareness of how this approach can be applied in clinical pharmacology and translational research settings. Therefore, the American Society of Clinical Pharmacology & Therapeutics (ASCPT) held a workshop on March 21st, 2023 entitled "Advancing the Utilization of Real-World Data (RWD) and Real-World Evidence (RWE) in Clinical Pharmacology and Translational Research." The work described herein is a summary of the workshop proceedings.
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