评估尿道瘤学临床试验中基于性别的入学差距
Madison K Krischak1, Merrick Bank2, Stephanie Daignault-Newton1
1Department of Urology, University of Michigan, Ann Arbor, MI, USA.
Urologic oncology
|August 19, 2025
概括
癌试验往往低于女性,与膀癌试验不同. 确保在泌尿瘤学临床试验中公平的性别代表性对于可普遍化和有效的治疗至关重要.
科学领域:
- 尿道瘤学 尿道瘤学
- 临床试验设计 临床试验设计
- 健康 公平 卫生 公平
背景情况:
- 泌尿系统癌症影响男性和女性,需要在临床试验中进行代表性招生.
- 治疗有效性和安全性的基于性别的差异强调了比例女性参与的重要性.
- 目前在泌尿瘤学试验中女性的代表性仍然在很大程度上是未知的.
研究的目的:
- 评估参与膀和癌临床试验的女性比例.
- 将招生比例与女性这些癌症的发病率进行比较.
- 在泌尿外科瘤学研究中发现女性代表性的差异.
主要方法:
- 自2007年以来在ClinicalTrials.gov注册的膀和癌试验的分析.
- 从试验结果中提取女性参与者比例.
- 观察到的入学率与估计的女性癌症发病率的比较.
主要成果:
- 癌试验的中位数为29%的女性,低于预期的36%的发病率.
- 只有28%的癌试验达到或超过了女性参与者的预期比例.
- 膀癌试验的中位数为24%的女性,与24%的发病率保持一致.
结论:
- 癌临床试验经常缺乏女性的代表性招生.
- 膀癌试验表明女性的代表性足够.
- 需要进一步努力,以确保在泌尿瘤学试验中公平的性别代表,以改善治疗结果.
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