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KMID : 1011320230150010011
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Journal of Pharmacoepidemiology and Risk Management
2023 Volume.15 No. 1 p.11 ~ p.22
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Comparison of Recent Trends in Study Design and Data Analysis Guidelines Using Real-World Data/Real-World Evidence in the United States, Europe, and South Korea and Implication of Development Direction in Future
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Jeon Min-Jeong
Ha Min-Young
Sung Hi-Gin
Lee Hye-Sung
Song Jae-Hwan
Shin Ju-Young
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Abstract
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After enacting the 21st Century Cures Act of 2016, real-world data (RWD) and realworld evidence (RWE) have been increasingly used to support drug development and approval worldwide. The importance of RWD/RWE is growing for decisionmaking, while the reliability of RWD/RWE is still a concern regarding the quality of data, reproducibility, and transparency. Regulatory agencies have published diverse guidelines to encourage the appropriate use of RWD/RWE, but there are differences in practical information detailing methodological and analytic approaches among countries. We compared guidelines focusing on study design and data analysis for RWD/RWE in the United States, Europe, South Korea from 2017 to 2022. We summarized RWD/RWE guidelines according to the timeline and conducted a GAP analysis from the following perspectives: (1) the roadmap for the use of RWD/RWE; (2) the current guideline for study design and data analysis; (3) features of guideline. Based on our findings, we suggest a future direction for developing governance in terms of study design and data analysis to enhance the utilization of RWD/RWE in South Korea.
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KEYWORD
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Real-World Data, Real-World Evidence, Guidelines, Study design, Data analysis
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