Abstract–Coronavirus disease 2019 (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 (ICEs) 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 ICEs, 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.

摘要： 2019 年冠状病毒病（COVID-19）的爆发已迅速演变成全球大流行。 COVID-19 对肿瘤学患者旅程的影响给试验结果的解释及其对未来临床实践的广泛适用性带来了新的风险。我们确定了肿瘤学临床试验中因 COVID-19 可能发生的关键并发事件 (ICE)，重点关注事件发生时间终点，并讨论了与 ICH E9 附录中引入的其他估计属性有关的注意事项。我们根据其与恶性肿瘤和治疗的关系以及其后数据的可解释性，提出处理 COVID-19 相关 ICE 的策略。我们认为，在没有 COVID-19 大流行的世界中进行的临床试验目标仍然有效。估算框架提供了一种通用语言，以结构化和透明的方式讨论 COVID-19 的影响。这表明该框架的适用性甚至可能超出其最初的预期。