论文标题

遮挡的作用:ICH E9(R1)附录的潜在扩展在估算和敏感性分析中,以进行事件时间的肿瘤学研究

The Role of Occlusion: Potential Extension of the ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis for Time-to-Event Oncology Studies

论文作者

Siegel, Jonathan M, Weber, Hans-Jochen, Englert, Stefan

论文摘要

ICH E9(R1)估计指南1术语并未完全满足复杂肿瘤环境中事实估计的概念需求。我们先前描述了如何将终止时间终点的审查和审查机制嵌入ICH E9(R1)估算指导术语中。制药行业工作组的第二篇论文介绍了肿瘤学检查机制的估计值,该机制在肿瘤学临床环境中讨论了与其他某些治疗领域以及ICH E9(R1)指南的扩展相比,可能需要不同方法的特殊问题。在遮挡事件的更广泛背景下讨论了审查的概念,遮挡代表了进一步的后续措施和/或从分析中删除进一步收集的数据的任何损失。闭塞构成了一个比估算和指南的交流事件和终端事件术语更广泛的概念,并且适合描述和处理诸如从评估或不同估算要求冲突的情况下撤回的情况。我们表征,提供其他细节,实践含义以及有关处理遮挡事件的每个估算策略的应用。

The ICH E9 (R1) Estimands Guidance1 terminology does not completely address the conceptual needs of time-to-event estimands in the complex oncology context. We previously described how censoring and censoring mechanisms for time-to-event endpoints can be embedded into the ICH E9 (R1) Estimands Guidance terminology. This second paper by the Pharmaceutical Industry Working Group on Estimands in Oncology Censoring Mechanisms Subteam discusses special issues in the oncology clinical context that may require different approaches than some other therapeutic areas as well as an extensions of the ICH E9 (R1) guidance. The concept of censoring is discussed in the broader context of occluding events, with occlusion representing any loss to further follow-up and/or removal of further collected data from analysis. Occlusion constitutes a broader concept than the estimand guidance's intercurrent event and terminal event terminology and is appropriate to describe and handle situations like withdrawal from assessments or situations where the requirements of different estimands conflict. We characterize, provide additional details, practical implications, and examples on the application of each estimands strategy for handling occluding events.

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