数据与安全监测委员会在实施试验中的作用：何时具有合理性？
The role of data and safety monitoring boards in implementation trials: When are they justified?
作者信息
Fiscella Kevin, Sanders Mechelle, Holder Tameir, Carroll Jennifer K, Luque Amneris, Cassells Andrea, Johnson Brent A, Williams Stephen K, Tobin Jonathan N
机构信息
Department of Family Medicine, University of Rochester Medical Center, Rochester, NY, USA.
Clinical Directors Network, Inc. (CDN), New York, NY, USA.
出版信息
J Clin Transl Sci. 2020 Mar 5;4(3):229-232. doi: 10.1017/cts.2020.19.
Abstract
The National Institutes of Health requires data and safety monitoring boards (DSMBs) for all phase III clinical trials. The National Heart, Lung and Blood Institute requires DSMBs for all clinical trials involving more than one site and those involving cooperative agreements and contracts. These policies have resulted in the establishment of DSMBs for many implementation trials, with little consideration regarding the appropriateness of DSMBs and/or key adaptations needed by DSMBs to monitor data quality and participant safety. In this perspective, we review the unique features of implementation trials and reflect on key questions regarding the justification for DSMBs and their potential role and monitoring targets within implementation trials.
摘要
美国国立卫生研究院要求所有III期临床试验都要设立数据与安全监测委员会（DSMBs）。美国国立心肺血液研究所要求所有涉及多个地点以及那些涉及合作协议和合同的临床试验都要设立DSMBs。这些政策导致许多实施试验都设立了DSMBs，但很少考虑DSMBs的适用性和/或DSMBs监测数据质量和参与者安全所需的关键调整。从这个角度出发，我们回顾了实施试验的独特特征，并思考了关于DSMBs设立的合理性及其在实施试验中的潜在作用和监测目标的关键问题。
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