在AstraZeneca赞助的临床试验中,美国参与者的多样性
Claudia Cabrera1, Daniel Fernández-Llaneza2, Zara Ghazoui3
1Real World Science and Analytics, BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden.
Contemporary clinical trials
|March 11, 2024
概括
阿斯特拉泽内卡的临床试验大致反映了美国人口普查对种族,种族和性别的人口统计数据. 进一步的举措旨在加强在临床研究中公平招募患者.
科学领域:
- 临床试验多样性 临床试验多样性
- 在研究中的健康公平.
- 患者的代表性 患者的代表性
背景情况:
- 确保安全有效的药物需要进行临床试验,以招募代表性的患者群体.
- 在临床试验中报告的种族,族裔和性别代表性的不平衡凸显了公共卫生需求.
- 对患者注册的全面分析对于提高试验代表性至关重要.
研究的目的:
- 评估AstraZeneca (AZ) 赞助的美国临床试验中的种族/种族和性别代表性.
- 将AZ试验的人口结构与2019年美国人口普查数据进行比较.
- 确定在公平的患者入学方面改善的潜在领域.
主要方法:
- 分析了2010年至2022年期间在美国进行的246项AZ赞助的临床试验.
- 包括95,372名患者,具有完整的种族/种族和性别记录.
- 试验中的人口比例与2019年美国人口普查数据的比较.
主要成果:
- 在AZ试验中的整体种族/种族比例与美国人口普查数据密切相关 (白人:69.5%与60.1%,黑人:13.3%与12.5%,亚洲人:1.8%与5.8%,西班牙裔:14.4%与18.5%).
- 在AZ试验中的性别代表性与美国人口普查呈现一致 (男性:52.4%与49.2%,女性:47.6%与50.8%).
- 在AZ的不同治疗领域和试验阶段观察到代表性的变化.
结论:
- 这项研究提供了关于AstraZeneca临床试验代表性的第一个详细见解.
- 由AZ赞助的试验通常表现出与美国人口普查人口统计数据在种族,种族和性别方面的广泛一致.
- 阿斯特拉泽内卡正在实施健康公平倡议,以进一步改善未来试验中公平的患者入学率.
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