[泌尿瘤学临床试验中的性别/性别特异性差异]
Marie Christine Roesch1, Lea Sophie Lütje1, Nils Gilbert1
1Department of Urology, University Hospital Schleswig-Holstein Campus Lübeck, Lübeck, Germany.
Aktuelle Urologie
|January 28, 2025
概括
临床试验可能会显示出癌症结果中的性别和性别差异,但药物批准和剂量很少反映这一点. 本综述探讨了尿瘤学试验中的这些差异.
科学领域:
- 尿瘤学 尿瘤学
- 临床试验 临床试验
- 健康差异 在健康上的差异
背景情况:
- 临床试验中的子组分析可以揭示癌症结局中的性别和性别依赖差异.
- 尽管有这些发现,药物批准和剂量建议很少是性别或性别特定的.
- 临床试验的入学率往往与现实世界的基于性别和性别的发病率和死亡率不一致.
研究的目的:
- 突出和分析侧重于泌尿瘤学的临床试验中的性别和性别差异.
- 强调需要在泌尿瘤学研究和治疗中采用适合性别和性别的方法.
主要方法:
- 审查现有的文献和从泌尿瘤学临床试验的子组分析.
- 检查药物批准和剂量推数据与已识别的性别/性别差异相关的数据.
- 临床试验招生人口统计数据与流行病学数据的比较.
主要成果:
- 在泌尿瘤学子组分析中观察到癌症结局的显著性别和性别依赖的变化.
- 目前的药物批准流程和剂量指南不足以解决这些已识别的差异.
- 在试验参与者的人口统计和一般人群中尿瘤疾病的性别/性别分布之间存在着持续的差距.
结论:
- 在泌尿瘤学临床试验中存在显著的性别和性别差异,需要引起注意.
- 当前药物开发和批准的做法未能充分纳入性别和性别方面的考虑.
- 需要进一步的研究和政策变化,以确保所有性别和性别的人均获得公平有效的泌尿瘤治疗.
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