데이터 모니터링 위원회 지침의 최신 동향 ; 주요 해외 규제 당국의 임상시험 관련 지침을 중심으로

Abstract

Background : Clinical trials are becoming increasingly globalized across multiple institu tions, aided by advancements in information technology and the development of statisti cal methods for analyzing trial data. There has been a growing focus on the importance of Data Monitoring Committees (DMC), which ensure the scientific value, integrity, efficacy or futility of clinical trials. Methods : DMC guidelines in the US, Europe, and Japan were reviewed and compared to underscore the necessity, establishment, operation and independence of DMCs. Results : A DMC is an independent group of experts with relevant expertise that regularly reviews accumulating data from clinical trials, providing recommendations to sponsors regarding trial continuation, modification, or termination, thus ensuring both patient safety and scientific integrity. A DMC uniquely oversees unblinded safety and effec tiveness data. The main objective in all DMC activities is to maintain the integrity and credibility of ongoing clinical trials, thereby policies should be in place to prevent the dissemination of interim analysis results. Conclusion : As the use and capabilities of DMCs increase in clinical trials, it will be nec essary to develop standardized and practical DMC charters and standard operating proce dures for their appropriate use.