It is unprecedented: trial management during the COVID-19 pandemic and beyond
It is unprecedented: trial management during the COVID-19 pandemic and beyond
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DOI：
10.1186/s13063-020-04711-6
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发表时间：
2020-09-11
期刊：
影响因子：
2.5
通讯作者：
McDonald, Alison
中科院分区：
文献类型：
--
作者：
Mitchell, Eleanor J.;Ahmed, Khaled;McDonald, Alison
COVID-19大流行给临床试验界带来了独特的挑战，无论是在快速建立COVID-19临床试验方面，还是在许多现有的非COVID-19研究方面，要么暂时暂停（无论是完全暂停还是暂停）某些活动）和/或调整其流程。试验管理人员在决策、进行风险评估和调整试验流程方面发挥了关键作用，并与研究团队的其他成员密切合作。本文介绍了一些方法，其中审判管理流程已被改变和审判管理人员发挥了关键作用。它诞生于英国试验管理者网络（UKTMN）成员的英国试验管理者之间的讨论，UKTMN是一个由管理非商业试验的试验管理专业人员组成的全国性网络。在这个前所未有的时代，临床试验面临着许多不确定性和广泛的挑战，包括在疫情中优先考虑患者安全，同意并招募新参与者参与试验、数据收集和管理以及干预措施的实施。在许多情况下，招聘已经暂停，同时采取了缓解措施，以继续收集数据。我们实施了创新的解决方案，以确保我们在可能的情况下继续提供高质量的临床试验。技术为这些挑战提供了许多解决方案，试验管理人员在继续提供临床试验的同时也适应了新的工作方式。试验管理团队现在面临着重新启动临床试验的新的不确定性，目前还不清楚这将如何进行，尽管与申办者，资助者和研究中心团队合作显然是优先事项。临床试验团队共同努力，以确保他们的试验快速适应，同时确保受试者的安全是最重要的。有明显的例子表明，试验界聚集在一起分享经验和专业知识，这在未来应该继续下去，以确保所开发的创新实践嵌入未来临床试验的设计和实施中。
The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporarily paused (whether that is a complete pause or pause in some activities) and/or adapting their processes. Trial managers have played a key role in decision-making, undertaking risk assessments and adapting trial processes, working closely with other members of the research team. This article presents some of the ways in which trial management processes have been altered and the key role that trial managers have played. It has been born out of discussions between trial managers in the UK who are members of the UK Trial Managers' Network (UKTMN), a national network of trial management professionals managing non-commercial trials.In these unprecedented times, clinical trials have faced many uncertainties and broad-ranging challenges encompassing a range of activities including prioritising patient safety amidst the pandemic, consenting and recruiting new participants into trials, data collection and management and intervention delivery. In many cases, recruitment has been paused whilst mitigations have been put in place to continue data collection. Innovative solutions have been implemented to ensure we continue, where possible, to deliver high-quality clinical trials. Technology has provided many solutions to these challenges, and trial managers have adapted to new ways of working whilst continuing to deliver their clinical trials. Trial management groups are now faced with new uncertainties around re-starting clinical trials, and it is unclear currently how this will go, though working together with sponsors, funders and site teams is clearly a priority.Clinical trial teams have worked together to ensure their trials have adapted quickly whilst ensuring participant safety is given utmost importance. There are clear examples where the trial community have come together to share experiences and expertise, and this should continue in the future to ensure the innovative practices developed become embedded in the design and conduct of clinical trials in the future.