Sanchez-Kam Matilde, Gallo Paul, Loewy John, Menon Sandeep, Antonijevic Zoran, Christensen Jared, Chuang-Stein Christy, Laage Thomas
1 Biostatistics and Data Management, Arena Pharmaceuticals Inc, San Diego, CA, USA.
2 Novartis Pharmaceuticals, East Hanover, NJ, USA.
Ther Innov Regul Sci. 2014 May;48(3):316-326. doi: 10.1177/2168479013509805.
Adaptive clinical trials require access to interim data to carry out trial modification as allowed by a prespecified adaptation plan. A data monitoring committee (DMC) is a group of experts that is charged with monitoring accruing trial data to ensure the safety of trial participants and that in adaptive trials may also play a role in implementing a preplanned adaptation. In this paper, we summarize current practices and viewpoints and provide guidance on evolving issues related to the use of DMCs in adaptive trials. We describe the common types of adaptive designs and point out some DMC-related issues that are unique to this class of designs. We include 3 examples of DMCs in late-stage adaptive trials that have been implemented in practice. We advocate training opportunities for researchers who may be interested in serving on a DMC for an adaptive trial since qualified DMC members are fundamental to the successful execution of DMC responsibilities.
适应性临床试验需要获取中期数据，以便按照预先指定的适应性计划进行试验调整。数据监测委员会（DMC）是一组专家，负责监测不断积累的试验数据，以确保试验参与者的安全，并且在适应性试验中，还可能在实施预先计划的调整方面发挥作用。在本文中，我们总结了当前的实践和观点，并就适应性试验中与数据监测委员会使用相关的不断演变的问题提供指导。我们描述了适应性设计的常见类型，并指出了这类设计特有的一些与数据监测委员会相关的问题。我们列举了3个在实际中实施的晚期适应性试验中的数据监测委员会实例。我们主张为可能有兴趣在适应性试验的数据监测委员会任职的研究人员提供培训机会，因为合格的数据监测委员会成员是成功履行数据监测委员会职责的基础。
