论文标题
准确收集停用治疗的原因,以更好地定义临床试验中的估计值
Accurate collection of reasons for treatment discontinuation to better define estimands in clinical trials
论文作者
论文摘要
背景:终止治疗的原因不仅要了解实验治疗的收益和风险概况,而且还可以帮助选择适当的策略来定义估计值时处理间事件。当前使用的案例报告表(CRF)通常会混合进行治疗中断的根本原因,并决定中断治疗的决定,通常导致不准确的治疗原因中断。方法和结果:我们对胰岛素PEGLISPRO的9阶段2和3阶段研究的治疗中断数据进行了系统地审查和分析。分析中总共包括857名参与者。我们的审查表明,由于CRF中存在的停用治疗的多项选择选择,有时出于相同的基本原因导致治疗中断的原因有时会记录不同的原因。基于我们的审查和分析,我们建议一种中间解决方案和一种更系统的方法来改善当前的CRF治疗中断。结论:这项研究提供了有关如何优化CRF记录治疗中断的洞察力和方向。需要进行进一步的工作,以将学习纳入临床数据交换标准财团标准。
Background: Reasons for treatment discontinuation are important not only to understand the benefit and risk profile of experimental treatments, but also to help choose appropriate strategies to handle intercurrent events in defining estimands. The current case report form (CRF) commonly in use mixes the underlying reasons for treatment discontinuation and who makes the decision for treatment discontinuation, often resulting in an inaccurate collection of reasons for treatment discontinuation. Methods and results: We systematically reviewed and analyzed treatment discontinuation data from nine phase 2 and phase 3 studies for insulin peglispro. A total of 857 participants with treatment discontinuation were included in the analysis. Our review suggested that, due to the vague multiple-choice options for treatment discontinuation present in the CRF, different reasons were sometimes recorded for the same underlying reason for treatment discontinuation. Based on our review and analysis, we suggest an intermediate solution and a more systematic way to improve the current CRF for treatment discontinuations. Conclusion: This research provides insight and directions on how to optimize the CRF for recording treatment discontinuation. Further work needs to be done to build the learning into Clinical Data Interchange Standards Consortium standards.