Ex) Article Title, Author, Keywords
Ex) Article Title, Author, Keywords
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.
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
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.
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.
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