我们通过检查ClinicalTrials.gov (AACT)上关于头颈癌 (HNC) 临床研究中是否包含了性别和/或性别 (S/G) 的内容，以及在特定亚组（即口腔、喉咙和峡部）中是否提到了人乳头状瘤病毒 (HPV)。只有5%的HNC研究中提到了将S/G作为计划分析变量。与干预性研究相比，观察性研究对待S/G作为分析变量的比例更高（10% vs 5%，P值≤ 0.001）。提到S/G的研究中，有8%涉及超过100名受试者，而有4%涉及少于100名受试者（P值≤ 0.001）。在随机方案中，提到S/G的研究在计划样本超过100名患者且包含HPV状况时更多（P值< 0.05）。小规模对照研究对S/G作为分析变量的提及比例较低，而在无对照研究中较高（分别是4%和10%，其中对于少于100名受试者的研究）。在样本量超过100名受试者的对照和随机研究中，存在更显著的S/G被作为分析变量提及情况。只有18%的口腔腔喉部研究提到了HPV。干预性研究在HNC研究设计中通常没有考虑到S/G。因此，尽管是基础但在涉及HNC的研究中，往往没有考虑到S/G变量。在发表在科学期刊上的试验中（P值= 0.01），以及最近的临床试验中（P值= 0.002），S/G被更多地考虑到，这表明人们越来越意识到其重要性。然而，有必要系统地包括S/G在研究设计中，以更好地突出与性别相关的疾病发病率和预后差异，并使科学和医学充满适当的生物学和文化差异。© 2023. Nature Publishing Group UK.

We analyzed the inclusion of sex and/or gender (S/G) in Head and Neck Cancer (HNC) clinical studies, through inspecting ClinicalTrials.gov (AACT) and the mention of Human Papilloma Virus (HPV) on a specific subgroup, namely oral cavity, larynx and oropharynx. Only 5% of HNC studies mention S/G as a planned analytical variable. Proportionally more observational studies treated S/G as an analytical variable than interventional studies (10% vs 5%, P-value ≤ 0.001), 8% of studies that mentioned S/G involved more than 100 subjects while 4% less than 100 (P-value ≤ 0.001). In randomized protocols, S/G was mentioned more in studies with a planned sample of more than 100 patients and including HPV status (P-value < 0.05). Small controlled studies have lower mention of S/G as an analytical variable than uncontrolled studies (4% and 10%, respectively among studies with less than 100 subjects). Significantly greater mention of S/G as an analytical variable is observed in controlled and randomized studies with a sample size greater than 100 subjects. HPV was mentioned in only 18% of oral cavity-larynx-oropharynx studies. Interventional studies do not regularly account for S/G during HNC study design. Thus, although fundamental, in studies concerning HNC the S/G variable is often not considered. In trials published in scientific journals (P-value = 0.01) and in more recent clinical trials (P-value = 0.002), S/G is taken more into account suggesting an increasing awareness on its importance. However, the need to systematically include S/G in study design clearly emerges, to better highlight sex-related differences in disease incidence and prognosis and best imbue science and medicine with the proper biological and cultural differences.© 2023. Nature Publishing Group UK.