Dilts Natalie A, Harrell Frank E, Lindsell Christopher J, Nwosu Samuel, Stewart Thomas G, Shotwell Matthew S, Pulley Jill M, Edwards Terri L, Serdoz Emily Sheffer, Benhoff Katelyn, Bernard Gordon R
Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN, USA.
Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
J Clin Transl Sci. 2022 Apr 11;6(1):e49. doi: 10.1017/cts.2022.387. eCollection 2022.
As clinical trials were rapidly initiated in response to the COVID-19 pandemic, Data and Safety Monitoring Boards (DSMBs) faced unique challenges overseeing trials of therapies never tested in a disease not yet characterized. Traditionally, individual DSMBs do not interact or have the benefit of seeing data from other accruing trials for an aggregated analysis to meaningfully interpret safety signals of similar therapeutics. In response, we developed a compliant DSMB Coordination (DSMBc) framework to allow the DSMB from one study investigating the use of SARS-CoV-2 convalescent plasma to treat COVID-19 to review data from similar ongoing studies for the purpose of safety monitoring.
The DSMBc process included engagement of DSMB chairs and board members, execution of contractual agreements, secure data acquisition, generation of harmonized reports utilizing statistical graphics, and secure report sharing with DSMB members. Detailed process maps, a secure portal for managing DSMB reports, and templates for data sharing and confidentiality agreements were developed.
Four trials participated. Data from one trial were successfully harmonized with that of an ongoing trial. Harmonized reports allowing for visualization and drill down into the data were presented to the ongoing trial's DSMB. While DSMB deliberations are confidential, the Chair confirmed successful review of the harmonized report.
It is feasible to coordinate DSMB reviews of multiple independent studies of a similar therapeutic in similar patient cohorts. The materials presented mitigate challenges to DSMBc and will help expand these initiatives so DSMBs may make more informed decisions with all available information.
随着针对新冠疫情的临床试验迅速启动，数据与安全监测委员会（DSMB）在监督针对一种尚未明确特征的疾病且从未进行过测试的疗法试验时面临着独特挑战。传统上，各个DSMB之间不进行互动，也无法受益于查看其他正在进行的试验数据以进行汇总分析，从而无法有意义地解读类似疗法的安全信号。为此，我们开发了一个合规的DSMB协调（DSMBc）框架，使一项研究新冠病毒康复期血浆治疗新冠病毒疾病的DSMB能够审查类似正在进行的研究的数据，以进行安全监测。
DSMBc流程包括DSMB主席和委员会成员的参与、合同协议的执行、安全的数据获取、利用统计图表生成统一报告以及与DSMB成员进行安全的报告共享。制定了详细的流程图、一个用于管理DSMB报告的安全门户以及数据共享和保密协议的模板。
四项试验参与其中。一项试验的数据成功与另一项正在进行的试验的数据进行了统一。为正在进行的试验的DSMB提供了能够直观呈现数据并深入挖掘数据的统一报告。虽然DSMB的审议是保密的，但主席确认已成功审查了统一报告。
在相似患者群体中协调对类似疗法的多个独立研究进行DSMB审查是可行的。所提供的材料减轻了DSMBc面临的挑战，并将有助于扩大这些举措，以便DSMB能够利用所有可用信息做出更明智的决策。
