Retired, Chevy Chase, MD.
Wittes LLC, Washington, DC.
NEJM Evid. 2024 Sep;3(9):EVIDctw2400058. doi: 10.1056/EVIDctw2400058. Epub 2024 Aug 27.
AbstractClinical trials investigating novel or high-risk interventions often use data monitoring committees (DMCs) to ensure that the participants' best interests are safeguarded. The typical DMC charter describes procedures by which the DMC operates, including important details concerning organizational structure, membership, meeting frequency, statistical monitoring guidelines, and contents of DMC reports for interim review. These charters, however, are not routinely publicly available; in some cases, their access could be important to the interpretation of trial results. We recommend including DMC charters for such trials in ClinicalTrials.gov at the time of trial completion; trial protocols, informed consent documents, and statistical analysis plans are already available in this repository.
摘要
研究新型或高风险干预措施的临床试验通常使用数据监测委员会（DMC）来确保参与者的最佳利益得到保障。典型的 DMC 章程描述了 DMC 的运作程序，包括有关组织结构、成员资格、会议频率、统计监测指南以及 DMC 中期审查报告内容的重要细节。然而，这些章程通常并不公开；在某些情况下，对于解释试验结果，这些章程的使用可能很重要。我们建议在试验完成时将此类试验的 DMC 章程包含在 ClinicalTrials.gov 中；该存储库中已经提供了试验方案、知情同意书和统计分析计划。
