胃肠癌试验的差异招募:与现实世界相比,分析人口差距
Wissam Ghusn1,2, Elisia Maalouf3, Noura Jawhar4
1Department of Internal Medicine, Boston University, Boston, MA, USA.
Journal of gastrointestinal oncology
|November 12, 2025
概括
胃肠道癌症临床试验往往低于老年人和少数群体,影响治疗公平. 在随机临床试验中解决这些人口差异对于促进所有患者的癌症护理至关重要.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 健康差异 在健康上的差异
背景情况:
- 胃肠道 (GI) 癌症对全球健康构成重大负担,导致大量的发病率和死亡率.
- 随机临床试验 (RCT) 对于开发新的癌症疗法至关重要,但人们担心它们对不同患者群体的概括性.
- 在试验中特定的人口群体的代表性不足可能会限制研究结果的外部有效性,并阻碍公平待遇的结果.
研究的目的:
- 将肠道癌RCT参与者的人口特征与现实数据进行比较.
- 在GI癌症临床试验中确定年龄,性别,种族和民族的特定差异.
- 评估这些差异对试验结果概括性的影响,并为包容性研究的战略提供信息.
主要方法:
- 进行了在clinicaltrials.gov (2000-2024) 中注册的肠胃癌RCT的回顾性分析.
- 报告人口统计数据 (年龄,性别,种族,种族) 的试验按癌症亚型分类.
- 参与者的人口分布与SEER计划中的真实发病率数据进行了比较,以量化代表性差异.
主要成果:
- 老年人 (>65岁) 在多种胃肠道癌亚型中总是代表性不足.
- 在食道和肝癌试验中,男性参与者比例不够.
- 在胰腺,肝脏和胆管癌研究中观察到显著的种族和种族不平衡,白人参与者过多,黑人,亚洲人和西班牙裔人口不足.
结论:
- 胃肠道癌RCT中持续存在的人口差异,特别是影响老年人和少数群体,限制了试验证据的概括性.
- 这些差异可能会延续癌症治疗现有的差距,并强调需要更具包容性的研究.
- 实施包容性招聘策略和适应性试验设计对于确保所有多样化的患者群体获得公平的治疗效益至关重要.
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