排除标准如何阻碍不同种族和民族群体的肺癌研究资格
Jennifer Y Kim1, Abigail Dirks1, Ruby Madison Ford1
1Tufts Center for the Study of Drug Development, Tufts School of Medicine, Boston, Massachusetts, United States of America.
PLOS digital health
|March 10, 2026
概括
对肺癌临床试验的议定书资格标准不成比例地将种族和少数民族排除在外,原因是并发症. 黑人/非裔美国人和亚裔美国人/太平洋岛民患者更有可能被排除在外,阻碍了试验的包容性.
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:
- 在肺癌临床试验中,种族和少数民族人口的代表性不足.
- 协议的资格标准被怀疑是导致这种差异的因素,但其特征仍然不佳.
研究的目的:
- 量化临床试验因肺癌患者的种族和种族群体之间的共同疾病而被排除在外的可能性.
- 评估标准排斥标准是否不成比例地影响少数群体.
主要方法:
- 在ClinicalTrials.gov (2014-2024) 上注册的1134个肺癌临床试验的分析.
- 来自4,096名肺癌患者的电子病历 (EMR) 的并发症数据.
- 二元逻辑回归用于估计种族/种族的排斥概率,控制性别和收入.
主要成果:
- 亚裔美国人和太平洋岛民 (AAPI) 患者被排除在外的可能性是白人患者的1.8倍 (OR:1.8,95%CI:1.03-3.03).
- 黑人或非裔美国患者被排除在外的可能性是白人患者的1.6倍 (OR:1.6,95%CI:1.01-2.48).
- 伴随性疾病对少数群体的试验排除作出了重大贡献.
结论:
- 标准的肺癌临床试验排除标准可能会不成比例地选种族和少数民族患者.
- 这些标准构成了结构性障碍,导致黑人/非裔美国人和AAPI个人在研究中的代表性不足.
- 修订资格标准以反映现实世界的并发症负担可以提高试验的包容性和通用性.
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