论文标题

临床试验药物安全评估对COVID-19

Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19

论文作者

Nilsson, Mary, Crowe, Brenda, Anglin, Greg, Ball, Greg, Munsaka, Melvin, Shahin, Seta, Wang, Wei

论文摘要

在本文中,鉴于COVID-19大流行的潜在影响,我们对标准安全分析和临床试验安全数据的报告如何进行指导。影响可能包括错过的访问,评估的替代方法(例如虚拟访问),评估的替代位置(例如本地实验室)以及研究药物中断。我们专注于第2-4阶段临床试验的安全计划和提交的综合摘要。从白皮书和研讨会提出的推荐安全分析开始,这是FDA/Phuse协作的一部分(Phuse 2013,2015,2017,2019),我们评估可能需要进行哪些修改。 COVID-19的影响可能会平均影响治疗臂,因此,从受控数据的不良事件分析在很大程度上可以保持不变。但是,从不受控制的数据(包括开放标签扩展数据的摘要)中对摘要的解释将比通常更加谨慎。对于感兴趣的安全主题,需要特别考虑,尤其是由于19号感染或由于隔离或旅行限制(例如抑郁症)而预计将有更高发病率的事件。可能需要修改对实验室测量的分析,以说明当地和中央实验室的测量值的组合。

In this paper, we provide guidance on how standard safety analyses and reporting of clinical trial safety data may need to be modified, given the potential impact of the COVID-19 pandemic. The impact could include missed visits, alternative methods for assessments (such as virtual visits), alternative locations for assessments (such as local labs), and study drug interruptions. We focus on safety planning for Phase 2-4 clinical trials and integrated summaries for submissions. Starting from the recommended safety analyses proposed in white papers and a workshop, created as part of an FDA/PHUSE collaboration (PHUSE 2013, 2015, 2017, 2019), we assess what modifications might be needed. Impact from COVID-19 will likely affect treatment arms equally, so analyses of adverse events from controlled data can, to a large extent, remain unchanged. However, interpretation of summaries from uncontrolled data (summaries that include open-label extension data) will require even more caution than usual. Special consideration will be needed for safety topics of interest, especially events expected to have a higher incidence due to a COVID-19 infection or due to quarantine or travel restrictions (e.g., depression). Analyses of laboratory measurements may need to be modified to account for the combination of measurements from local and central laboratories.

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