미국, 유럽, 한국의 실사용데이터/실사용근거를 활용한 연구설계 및 데이터분석의 최신 가이드라인 비교 및 향후 발전방향 고찰 (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 Directio)

서지정보

· 발행기관 : 대한약물역학위해관리학회
· 수록지 정보 : 약물역학위해관리학회지 / 15권 / 1호 / 11 ~ 22페이지
· 저자명 : 전민정, 하민영, 성희진, 이혜성, 송재환, 신주영

초록

After enacting the 21st Century Cures Act of 2016, real-world data (RWD) and real world evidence (RWE) have been increasingly used to support drug development and approval worldwide. The importance of RWD/RWE is growing for decision making, 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.

영어초록

After enacting the 21st Century Cures Act of 2016, real-world data (RWD) and real world evidence (RWE) have been increasingly used to support drug development and approval worldwide. The importance of RWD/RWE is growing for decision making, 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.

참고자료

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