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Pharmacoepidemiology and Risk Management 2023; 15(1): 41-50

Published online March 31, 2023 https://doi.org/10.56142/perm.23.0008

Copyright © Korean Society for Pharmacoepidemiology and Risk Management.

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

데이터 접근, 연계, 검증을 위한 미국, 유럽, 한국의 현황 및 국내 개선사항 제언

MinJeong Jeon1, MinYoung Ha1, ChaeYoung Lee1, SongHee Kim2, InSun Oh3,4, HiGin Sung1, Ju-Young Shin1,5,6

전민정1, 하민영1, 이채영1, 김송희2, 오인선3,4, 성희진1, 신주영1,5,6

1School of Pharmacy, Sungkyunkwan University (SKKU), Suwon, Korea
2Pharmacovigilance Department, MediSafe, Seoul, Korea
3Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Canada
4Centre of Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Canada
5Department of Biohealth Regulatory Science, Sungkyunkwan University (SKKU), Suwon, Korea
6Department of Clinical Study Design & Evaluation, Samsung Advanced Institute for Health Sciences & Technology (SAIHST), Sungkyunkwan University (SKKU), Seoul, Korea

1성균관대학교 약학대학, 2메디세이프 약물감시부서, 3맥길대학교 역학, 생명통계 및 직업보건대학, 4유대인 종합병원 레이디 데이비스 연구소 임상역학센터, 5성균관대학교 바이오헬스규제과학과, 6삼성융합의과학원 임상연구설계평가학과

Correspondence to:Ju-Young Shin
School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangangu, Suwon 16419, Korea
Tel: +82-31-290-7702
Fax: +82-31-292-8800
E-mail: shin.jy@skku.edu

Received: March 7, 2023; Revised: March 16, 2023; Accepted: March 18, 2023

This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

KeywordsReal-World Data, Real-World Evidence, Data access, Data linkage, Data validation

Korean Society for Pharmacoepidemiology and Risk Management

Vol.16 No.2
September, 2024

eISSN 2982-5954

Frequency: Bimonthly

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