摘要翻译：
新冠肺炎疫情迅速演变为全球大流行。新冠肺炎对肿瘤学患者旅程的影响对解释试验结果及其在未来临床实践中的广泛适用性带来了新的风险。我们确定了肿瘤临床试验中可能因COVID-19而发生的关键并发事件，重点是时间到事件终点，并讨论了与ICH E9附录中引入的其他估计和属性有关的考虑因素。我们提出了处理COVID-19相关并发事件的策略，取决于它们与恶性肿瘤和治疗的关系以及它们之后数据的可解释性。我们认为，来自一个没有新冠肺炎疫情的世界的临床试验目标仍然有效。估计和框架提供了一种共同语言，以结构化和透明的方式讨论新冠肺炎的影响。这表明，该框架的适用性甚至可能超出其最初的目的。
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英文标题：
《Assessing the Impact of COVID-19 on the Objective and Analysis of
  Oncology Clinical Trials -- Application of the Estimand Framework》
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作者：
Evgeny Degtyarev and Kaspar Rufibach and Yue Shentu and Godwin Yung
  and Michelle Casey and Stefan Englert and Feng Liu and Yi Liu and Oliver
  Sailer and Jonathan Siegel and Steven Sun and Rui Tang and Jiangxiu Zhou
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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：
  COVID-19 outbreak has rapidly evolved into a global pandemic. The impact of COVID-19 on patient journeys in oncology represents a new risk to interpretation of trial results and its broad applicability for future clinical practice. We identify key intercurrent events that may occur due to COVID-19 in oncology clinical trials with a focus on time-to-event endpoints and discuss considerations pertaining to the other estimand attributes introduced in the ICH E9 addendum. We propose strategies to handle COVID-19 related intercurrent events, depending on their relationship with malignancy and treatment and the interpretability of data after them. We argue that the clinical trial objective from a world without COVID-19 pandemic remains valid. The estimand framework provides a common language to discuss the impact of COVID-19 in a structured and transparent manner. This demonstrates that the applicability of the framework may even go beyond what it was initially intended for.
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PDF链接：
https://arxiv.org/pdf/2006.04480