在NCI赞助的早期临床试验的人口趋势 (2000-2023):一个队列研究
Maria Farooq1, Elad Sharon2, Naoko Takebe3
1National Cancer Institute, Bethesda, United States.
Cancer discovery
|August 6, 2025
概括
在早期癌症临床试验中,老年人和西班牙裔/拉丁裔,亚洲裔/太平洋岛民以及非西班牙裔黑人人群体的患者入学率有所增加. 然而,代表性仍然落后于某些群体的发病率,这凸显了癌症试验获取的持续差异.
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:
- 早期临床试验对于癌症治疗的评估至关重要.
- 从历史上看,临床试验中的人口代表性一直是不均衡的.
- 了解招生趋势是改善公平获取的关键.
研究的目的:
- 分析2000-2023年国家癌症研究所 (NCI) 赞助的早期临床试验中的人口趋势.
- 评估患者代表性在不同年龄,种族和种族的变化.
- 确定影响试验招生和地理可访问性的因素.
主要方法:
- 来自NCI癌症治疗评估计划试验的大型患者子集 (N=16,609) 的分析.
- 使用了三年滚动平均和Joinpoint分析来查看招生趋势.
- 将美国居民数据与人口普查,地理和癌症发病率数据进行匹配.
主要成果:
- 在老年人 (65-84岁) 和西班牙裔/拉丁裔,亚洲裔/太平洋岛民以及非西班牙裔黑人患者中观察到增加的入学率.
- 拉丁裔和非拉丁裔黑人患者的参与率仍然低于癌症发病率.
- 美国印第安人和阿拉斯加土著人口的入学率可以忽略不计.
- 在2014年实验疗法临床试验网络实施后,改善了代表性和减少了旅行距离.
结论:
- 虽然早期癌症试验中的人口代表性有所改善,但仍然存在显著的差异.
- 实验疗法临床试验网络对试验访问和地理范围产生了积极的影响.
- 需要进一步努力,以确保所有患者群体的公平参与,特别是代表性不足的种族/民族群体.
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