Sydes Matthew R, Spiegelhalter David J, Altman Douglas G, Babiker Abdel B, Parmar Mahesh K B
MRC Clinical Trials Unit, 222 Euston Rd, London NW1 2DA, UK.
Clin Trials. 2004 Feb;1(1):60-79. doi: 10.1191/1740774504cn004rr.
To systematically review the published literature on data monitoring committees (DMCs) for randomized controlled trials (RCT) and summarize information and opinions on best practice. This was part of the DAMOCLES project.
A systematic and comprehensive search of five online bibliographic databases was performed, identifying 4007 potentially relevant articles. These were assessed in two stages by the authors. The 84 most relevant articles were agreed and were supplemented with extracts from 16 books: ultimately, 100 sources were reviewed. A series of 23 questions plus subquestions were developed to structure the data extraction and interpretation process.
Much has been written about DMCs but by a rather small community of authors. The papers included some results of surveys, but were mainly opinion pieces based on the authors' beliefs, practices and experiences. There is a lack of empirical evidence for many aspects of DMCs. There was a great range of detail in the literature relating to the prespecified questions. It was generally agreed that interim monitoring of accumulating data was necessary in some form for most trials. Questions such as membership of the DMC featured widely in the literature with opinions and practice ranging from 3-20 members, of whom between none and all should be independent. There was a consensus that formal statistical methods should be used as tools to guide decision making rather than as hard rules. Conversely, topics such as the training and experience required for DMC membership were discussed in very few papers.
There is a consensus in the published literature in a number of areas, although there are many different models for structure and functions of a DMC. While uncertainty remains about some issues, it is strongly recommended that an explicit set of guidelines (Charter) is prepared for each DMC prior to the start of the trial specifying clearly how it will operate.
系统回顾已发表的关于随机对照试验（RCT）数据监测委员会（DMC）的文献，并总结最佳实践的信息和观点。这是达摩克利斯项目的一部分。
对五个在线书目数据库进行系统全面的检索，识别出4007篇潜在相关文章。作者分两个阶段对这些文章进行评估。最终确定了84篇最相关的文章，并补充了16本书籍的摘录：总共审查了100个来源。制定了一系列23个问题及子问题，以构建数据提取和解释过程。
关于DMC的著述颇多，但作者群体相对较小。这些论文包含了一些调查结果，但主要是基于作者的信念、实践和经验的观点文章。DMC许多方面缺乏实证证据。文献中与预先设定问题相关的细节差异很大。人们普遍认为，大多数试验都需要以某种形式对累积数据进行中期监测。DMC成员资格等问题在文献中广泛出现，成员数量从3至20人不等，其中独立成员的数量从无到全部皆有。人们达成共识，应使用正式统计方法作为指导决策的工具，而非严格规则。相反，关于DMC成员所需培训和经验等主题的论文讨论极少。
尽管DMC的结构和功能有许多不同模式，但已发表文献在一些领域达成了共识。虽然某些问题仍存在不确定性，但强烈建议在试验开始前为每个DMC制定一套明确的指南（章程），清楚说明其运作方式。
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