Transparent and precise endpoint definitions are a crucial aspect of clinical trial conduct and reporting, and are used to communicate the benefit of an intervention. Previous studies have identified inconsistencies in endpoint definitions across oncological clinical trials. Here, the Head and Neck Cancer International Group assessed endpoint definitions from phase 3 trials or trials considered practice-changing for patients with recurrent or metastatic mucosal head and neck squamous cell carcinoma, published between 2008 and 2021. We identify considerable and global heterogeneity in endpoint definitions, which undermines the interpretation of results and development of future studies. We show how fundamental components of even incontrovertible endpoints such as overall survival vary widely, highlighting an urgent need for increased rigour in reporting and harmonisation of endpoints.

中文翻译：

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复发性和转移性粘膜头颈鳞状细胞癌试验中终点定义的评估：头颈癌国际小组共识建议


透明和精确的终点定义是临床试验实施和报告的一个重要方面，用于传达干预措施的益处。先前的研究已经发现肿瘤临床试验中终点定义的不一致。在此，头颈癌国际小组评估了 2008 年至 2021 年间发表的 3 期试验或被认为改变复发性或转移性粘膜头颈鳞状细胞癌患者实践的试验的终点定义。我们发现终点存在相当大的全球异质性。定义，这破坏了对结果的解释和未来研究的发展。我们展示了即使是无可争议的终点（例如总生存期）的基本组成部分也存在很大差异，这凸显了迫切需要提高报告的严谨性和终点的协调性。