Robust time-to-event endpoint definitions are crucial for the assessment of treatment effect and the clinical value of trial interventions. Here, the Head and Neck Cancer International Group investigated endpoint use in phase 3 trials and trials considered potentially practice-changing published between 2008 and 2021 in the curative-intent setting for patients with mucosal head and neck squamous cell carcinoma. Of the 92 trials reviewed, we show that all core components of endpoint reporting were heterogeneous, including definitions of common terms, such as overall survival and progression-free survival. Our report highlights the urgent need for harmonisation of fundamental components of clinical trial endpoints and the engagement of all stakeholders to ensure the transparent reporting of endpoint details.

中文翻译：

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粘膜头颈鳞状细胞癌治疗意向试验中终点定义的评估：头颈癌国际小组共识建议


稳健的事件发生时间终点定义对于评估治疗效果和试验干预的临床价值至关重要。在这里，头颈癌国际小组调查了 3 期试验中的终点使用情况，以及 2008 年至 2021 年间发表的被认为可能改变实践的试验，这些试验的目的是治疗粘膜头颈鳞状细胞癌患者。在审查的 92 项试验中，我们发现终点报告的所有核心组成部分都是异质的，包括常用术语的定义，例如总生存期和无进展生存期。我们的报告强调迫切需要协调临床试验终点的基本组成部分以及所有利益相关者的参与，以确保终点详细信息的透明报告。