A Practical Guide to Data Monitoring Committees in Adaptive Trials

作者：Sanchez Kam Matilde^*; Gallo Paul; Loewy John; Menon Sandeep; Antonijevic Zoran; Christensen Jared; Chuang Stein Christy; Laage Thomas

来源：Therapeutic Innovation & Regulatory Science, 2014, 48(3): 316-326.

DOI：10.1177/2168479013509805

• data monitoring committees
• adaptive trials
• practical guide
• examples

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.

• 出版日期2014-5