Pharmacoepidemiol Risk Manage.  2023 Mar;15(1):41-50. 10.56142/perm.23.0008.

Recent Trends in Real-World Data Access, Linkage and Validation of the United States, Europe, and South Korea and Further Recommendations for South Korea

• Jeon M
• Ha M
• Lee C
• Kim S
• Oh I
• Sung H
• Shin JY

• KMID: 2544376
• DOI: http://doi.org/10.56142/perm.23.0008

Abstract

21st Century Cures Act of 2016 sparked interest in real-world data (RWD) and real-world evidence (RWE) worldwide. South Korea published several RWD/RWE guidelines as well as the United States and Europe did to keep up with global trend. The Ministry of Food and Drug Safety published ‘Comprehensive Drug Safety Management Plan Phase I’ and it set the road map direction for the next five years as post-marketing pharmacovigilance and adverse effect analysis system operation using big data in 2020. Through this, it is expected to pay more attention to the possibility of RWD/RWE's use as a drug safety management tool in South Korea. To enhance the usage of RWD in South Korea, we need to understand current status of RWD platforms and policies. We investigated current status of systems and policies for health data access, linkage, and validation of the United States, Europe, and South Korea. Based on our research, we also suggest a new integration platform for data access, linkage, and validation to enhance the utilization of RWD/RWE in South Korea. (PeRM 2023;15:41-50)

Keyword

Real-World Data; Real-World Evidence; Data access; Data linkage; Data validation