Abstract–In this article, 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，我们就如何修改临床试验安全数据的安全分析和报告提供了指导。影响可能包括错过访视、替代评估方法（例如虚拟访视）、替代评估地点（例如当地实验室）以及研究药物中断。从 2-4 期临床试验的临床研究报告和综合提交文件中通常包含的安全性分析开始，我们评估可能需要进行哪些修改。如果 COVID-19 的影响对治疗组的影响相同，那么根据受控数据对不良事件进行的分析在很大程度上可以保持不变。然而，对来自不受控数据的摘要（包括开放标签扩展数据的摘要）的解释将需要比平常更加谨慎。需要特别考虑感兴趣的安全主题，特别是由于 COVID-19 感染或由于隔离或旅行限制（例如抑郁症）而预计发生率较高的事件。实验室测量的分析可能需要修改，以考虑当地和中央实验室的测量组合。