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Independent data monitoring committees: An update and overview

机译：独立的数据监控委员会：更新和概述

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An independent data monitoring committee's (IDMC's) duty is to ensure that the interests of the patients entered in the trial are being well served (i.e., the risk-benefit ratio is appropriate) and that the scientific integrity of the trial is maintained during the interim between trial initiation and trial completion. Industry sponsors form IDMCs to ensure an independent assessment to assure that the study participants are not exposed to unnecessary or unreasonable risks because of their trial participation and to ensure that the study is being conducted according to highest scientific and ethical standards. IDMCs are needed to analyze interim data for large randomized studies, in particular those that involve multiple sites and important clinical end points such as survival or disease progression. Ethical principles mandate that clinical trials begin with uncertainty as to Which treatment is better (clinical equipoise). This uncertainty should be maintained during study conduct and analysis unless there are compelling data that emerge during the conduct of the trial. Group sequential statistical designs offer a mechanism to consider terminating a trial early and the results made public if the interim data become sufficiently compelling. Interim monitoring of safety and efficacy data is an integral part of modern clinical trials. (c) 2015 Elsevier Inc. All rights reserved.
机译：独立数据监控委员会（IDMC）的职责是确保参加试验的患者的利益得到良好服务（即风险收益比合适），并在过渡期间保持试验的科学完整性。在试验启动和试验完成之间。行业赞助者组成IDMC，以确保进行独立评估，以确保研究参与者不会因为参加试验而面临不必要或不合理的风险，并确保研究按照最高的科学和道德标准进行。需要IDMC分析大型随机研究的中期数据，尤其是那些涉及多个部位和重要临床终点（例如生存或疾病进展）的研究。伦理原则要求临床试验首先要确定哪种治疗更好（临床平衡）。在研究进行和分析期间应保持这种不确定性，除非在试验进行期间出现令人信服的数据。分组顺序统计设计提供了一种机制，可以考虑尽早终止试验，并且如果中期数据变得足够有说服力，则可以公开结果。安全性和有效性数据的临时监视是现代临床试验的组成部分。 （c）2015 Elsevier Inc.保留所有权利。

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