论文标题
据估计框架，肿瘤学的估计时间和随访的损失是根据估计框架
Time-to-event estimands and loss to follow-up in oncology in light of the estimands framework
论文作者
论文摘要
活动时间估计是许多肿瘤学临床试验的核心。估计和框架（ICH E9指南附录）要求精确定义兴趣的治疗效果，以使与临床问题保持一致，并需要预先确定处理治疗开始后发生的跨际事件的处理，并排除对治疗效果的兴趣的观察或影响感兴趣的事件。我们讨论了临床试验设计和执行中的一个实际问题，即在某些临床背景下，系统地跟随患者进行感兴趣的事件是不可行的。在发生间事件的情况下，随访的损失会影响研究结果的含义和解释。我们为试验设计提供了建议，强调需要密切关注感兴趣和研究设计问题，对数据收集的影响以及其他实际含义的临床问题。如果不能系统地遵循患者，则可能需要妥协才能选择在这种情况下可以估计的最佳可用估计。我们讨论了敏感性和补充分析以检查感兴趣的假设的使用。
Time-to-event estimands are central to many oncology clinical trials. The estimand framework (addendum to the ICH E9 guideline) calls for precisely defining the treatment effect of interest to align with the clinical question of interest and requires predefining the handling of intercurrent events that occur after treatment initiation and either preclude the observation of an event of interest or impact the interpretation of the treatment effect. We discuss a practical problem in clinical trial design and execution, i.e. in some clinical contexts it is not feasible to systematically follow patients to an event of interest. Loss to follow-up in the presence of intercurrent events can affect the meaning and interpretation of the study results. We provide recommendations for trial design, stressing the need for close alignment of the clinical question of interest and study design, impact on data collection and other practical implications. When patients cannot be systematically followed, compromise may be necessary to select the best available estimand that can be feasibly estimated under the circumstances. We discuss the use of sensitivity and supplementary analyses to examine assumptions of interest.
