Pharmacoepidemiol Risk Manage.  2023 Mar;15(1):11-22. 10.56142/perm.23.0004.

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

• Jeon M
• Ha M
• Sung H
• Lee H
• Song J
• Shin JY

• KMID: 2544373
• DOI: http://doi.org/10.56142/perm.23.0004

Abstract

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. (PeRM 2023;15:11-22)

Keyword

Real-World Data; Real-World Evidence; Guidelines; Study design; Data analysis