ABSTRACT

In this paper, we provide guidance on how safety analyses and reporting of clinical trial safety data may need to be modified, given potential impact from the COVID-19 pandemic. 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. Starting from the safety analyses typically included in Clinical Study Reports for Phase 2-4 clinical trials and integrated submission documents, we assess what modifications might be needed.

If the impact from COVID-19 affects treatment arms equally, 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.

摘要

在本文中，考虑到COVID-19大流行的潜在影响，我们提供了有关如何可能需要修改安全性分析和临床试验安全性数据报告的指南。影响可能包括错过的访问，替代的评估方法（例如虚拟访问），替代的评估位置（例如本地实验室）以及研究药物中断。从通常针对2-4期临床研究的临床研究报告中包含的安全性分析以及完整的提交文件开始，我们评估可能需要进行哪些修改。

如果COVID-19的影响对治疗部门具有同等影响，则受控数据中不良事件的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）中解释摘要将比平时更加​​谨慎。对于感兴趣的安全主题，需要特别考虑，尤其是预计由于COVID-19感染或由于检疫或旅行限制（例如抑郁症）而发生率更高的事件。可能需要修改实验室测量值的分析，以说明本地和中央实验室的测量值组合。