论文标题
评估Covid-19对肿瘤学临床试验的目标和分析的影响 - 估计和框架的应用
Assessing the Impact of COVID-19 on the Objective and Analysis of Oncology Clinical Trials -- Application of the Estimand Framework
论文作者
论文摘要
Covid-19-19爆发已迅速发展为全球大流行。 Covid-19对肿瘤学对患者旅行的影响是解释试验结果及其对未来临床实践的广泛适用性的新风险。我们确定了肿瘤学临床试验中可能发生的关键事件，这些事件可能会在肿瘤学临床试验中进行，重点是事实终点，并讨论与ICH E9附录中引入的其他估计属性有关的考虑因素。我们提出策略来处理相关的19.相关事件，具体取决于它们与恶性肿瘤和治疗的关系以及之后的数据的解释性。我们认为，没有共同研究大流行的世界的临床试验目标仍然有效。估算和框架提供了一种通用语言，可以以结构化和透明的方式讨论Covid-19的影响。这表明框架的适用性甚至可能超出了最初的预期。
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.
