摘要翻译：
鉴于新冠肺炎疫情的潜在影响，我们在本文中提供了如何修改标准安全分析和临床试验安全数据报告的指导。影响可能包括错过访问、评估的替代方法（如虚拟访问）、评估的替代地点（如当地实验室）和研究药物中断。我们专注于2-4期临床试验的安全规划和提交的综合摘要。从白皮书和作为FDA/PHUSE合作（PHUSE 2013,2015,2017,2019）的一部分创建的研讨会中建议的安全分析开始，我们评估可能需要进行哪些修改。新冠肺炎的影响可能会同样影响治疗部门，因此根据受控数据对不良事件的分析在很大程度上保持不变。但是，从不受控制的数据（包括开放标签扩展数据的摘要）中解释摘要将需要比通常更加谨慎。需要特别考虑感兴趣的安全问题，尤其是由于新冠肺炎感染或隔离或旅行限制（例如抑郁症）而预期发病率较高的事件。对实验室测量结果的分析可能需要修改，以考虑到来自地方和中央实验室的测量结果的组合。
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英文标题：
《Clinical Trial Drug Safety Assessment for Studies and Submissions
  Impacted by COVID-19》
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作者：
Mary Nilsson (1), Brenda Crowe (1), Greg Anglin (1), Greg Ball (2),
  Melvin Munsaka (3), Seta Shahin (4), Wei Wang (5) ((1) Eli Lilly and Company,
  Indianapolis, IN USA, (2) Merck & Co., Inc., Rahway, NJ, USA, (3) AbbVie
  Inc., North Chicago, IL, USA, (4) Amgen Inc., Thousand Oaks, CA, USA, (5) Eli
  Lilly Canada Inc., Toronto, Ontario, Canada)
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最新提交年份：
2020
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分类信息：

一级分类：Quantitative Biology        数量生物学
二级分类：Other Quantitative Biology        其他定量生物学
分类描述：Work in quantitative biology that does not fit into the other q-bio classifications
不适合其他q-bio分类的定量生物学工作
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英文摘要：
  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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PDF链接：
https://arxiv.org/pdf/2006.05502