黑人和西班牙裔男性在转移性割抗性前列腺癌试验中的代表性不足 (2005-2021):呼吁采取行动
Canan D Dirican1, Sagar Patel2, Anas Al Mardini1
1NYMC Internal Medicine Residency Program at Saint Mary's and Saint Clare's, Denville, NJ.
JCO oncology practice
|November 24, 2025
概括
黑人男性面临高前列腺癌负担,但在临床试验中代表性不足. 他们参与转移性割耐药前列腺癌试验的比例有所下降,这凸显了改善试验多样性的需要.
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:
- 在全球范围内,黑人男性的前列腺癌发病率和死亡率最高.
- 转移性割抵抗性前列腺癌 (mCRPC) 不成比例地影响了这一群体.
- 临床试验往往缺乏对关键人口群体的充分代表.
研究的目的:
- 评估17年时间内的mCRPC临床试验中种族和民族群体的代表性趋势.
- 评估从2005年到2021年的mCRPC试验参与者人口统计数据的变化.
主要方法:
- 在clinicaltrials.gov (2005-2021) 上注册的33项mCRPCIII期和IV期试验的分析.
- 提取有关参与者的种族,种族和试验地理的数据.
- 评估随着时间的推移和资金来源的代表性趋势,使用随机效应模型对聚合的人口统计数据.
主要成果:
- 只有73%的试验报告了种族,42%报告了种族.
- 白人参与者占79.2%,亚洲人占10.8%,黑人或非洲裔美国人仅占3.8%.
- 在研究期间,黑人参与率从13.7%下降到3%;试验在地理上仅限于北美和欧洲.
结论:
- 在mCRPC试验中,存在着严重的种族和民族代表性不足,并且在mCRPC试验中恶化.
- 在试验设计,资金和监管监督方面急需进行结构性改革.
- 公平获得前列腺癌疗法和普遍性需要改善试验包容性.
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