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Pharmacoepidemiology and Risk Management 2024; 16(2): 113-123

Published online September 30, 2024 https://doi.org/10.56142/perm.24.0013

Copyright © Korean Society for Pharmacoepidemiology and Risk Management.

Utilization of Real-World Data/Real-World Evidence for Complementary and Alternative to Clinical Trials: Trends in Guideline Development from the United States, Europe, Japan, and South Korea

임상시험 보완 및 대체를 위한 실사용데이터/실사용근거 활용 현황: 미국, 유럽, 일본, 한국의 가이드라인 분석과 제언

JuEun Park1*, Jeong-Eun Lee2*, Yunju Choe2, Hyunah Jung2, Se Jung Park2, Jeong-in Oh1, Ju Hwan Kim1, Ju-Young Shin1,2,3

박주은1*, 이정은2*, 최윤주2, 정현아2, 박세정2, 오정인1, 김주환1, 신주영1,2,3

1School of Pharmacy, Sungkyunkwan University (SKKU), Suwon, Korea
2Department of Biohealth Regulatory Science, Sungkyunkwan University (SKKU), Suwon, Korea
3Department of Clinical Study Design & Evaluation, Samsung Advanced Institute for Health Sciences & Technology (SAIHST), Sungkyunkwan University (SKKU), Seoul, Korea

1성균관대학교 약학대학, 2성균관대학교 바이오헬스규제과학과, 3삼성융합의과학원 임상연구설계평가학과

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

*The first two authors contributed equally to this study.

Received: April 30, 2024; Revised: June 12, 2024; Accepted: July 6, 2024

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

The increasing development of new drugs for rare diseases has posed challenges to the use of randomization in clinical trials. Therefore, the importance of regulatory decision-making utilizing real-world data (RWD) and real-world evidence (RWE) to complementary and alternative clinical trials has become a focal point. The United States, Europe, and Japan have implemented relevant laws and regulations and are continuously developing guidelines in this field. In response to this trend, South Korea is also advancing its research on regulatory decision-making using RWD/ RWE. This study aimed to explore the current utilization status of RWD/RWE for complementing and alternating clinical trials by examining guidelines from the United States, Europe, Japan, and South Korea. Through a comparative analysis of guidelines from various countries, we have developed recommendations for essential guidelines tailored to South Korea. We expect this study to enhance rational and efficient decision-making in regulatory processes and lay the groundwork for establishing clinical research that utilizes RWD/RWE.

KeywordsReal-World Data, Real-World Evidence, Guideline, Clinical trials

Korean Society for Pharmacoepidemiology and Risk Management

Vol.16 No.2
September, 2024

eISSN 2982-5954

Frequency: Bimonthly

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