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Clinical Information

국내 및 해외의 임상시험 데이터모니터링위원회 지침의 현황

원문정보

Independent Data Monitoring Committees : Review of Current Guidelines

이보람, 이경은

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영어

Background: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. Methods: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. Results: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. Conclusion: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.

목차

ABSTRACT
 방법
 결과
  독립적 모니터링 위원회의 현황
  독립적 모니터링 위원회 지침서 비교
 고찰 및 결론
 감사의 말씀
 참고문헌

저자정보

  • 이보람 Bo Ram Lee. 충북대학교 약학대학
  • 이경은 Kyung Eun Lee. 충북대학교 약학대학

참고문헌

자료제공 : 네이버학술정보

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