Pharmacoepidemiol Risk Manage.  2024 Sep;16(2):113-123. 10.56142/perm.24.0013.

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

• Park J
• Lee JE
• Choe Y
• Jung H
• Park SJ
• Oh Ji
• Kim JH
• Shin JY

• KMID: 2564476
• DOI: http://doi.org/10.56142/perm.24.0013

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.

Keyword

Real-World Data; Real-World Evidence; Guideline; Clinical trials