임상시험 보완 및 대체를 위한 실사용데이터/실사용근거 활용 현 황: 미국, 유럽, 일본, 한국의 가이드라인 분석과 제언 (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)

서지정보

· 발행기관 : 대한약물역학위해관리학회
· 수록지 정보 : 약물역학위해관리학회지 / 16권 / 2호 / 113 ~ 123페이지
· 저자명 : 신주영, 박주은, 이정은, 최윤주, 정현아, 박세정, 오정인, 김주환

초록

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.

영어초록

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.

참고자료

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