多发性硬化3期临床试验中的种族和民族:系统性审查
Marta Ponzano1, Alessio Signori1, Andrea Bellavia2
1Department of Health Sciences, University of Genoa, Genoa, Italy.
概括
多发性硬化症 (MS) 的临床试验很少报告不同的种族和种族数据. 大多数参与者都是白人,这凸显了在研究设计和报告中提高代表性的需要.
科学领域:
- 临床研究 临床研究
- 流行病学 流行病学
- 健康差异 在健康上的差异
背景情况:
- 多发性硬化症 (MS) 在不同种族和民族群体中表现出明显的变化.
- 临床试验数据往往缺乏关于参与者的种族和种族的全面报告.
- 在临床试验中了解人口多样性对于公平的医疗保健至关重要.
研究的目的:
- 确定多发性硬化症临床试验中种族和民族报告的频率.
- 评估这些试验中参与者群体的多样性.
- 为了比较临床试验注册表及其出版物之间的报告标准.
主要方法:
- 2007年至2023年期间在ClinicalTrials.gov上注册的第三期临床试验的分析.
- 包含报告结果的试验,并随后搜索相应的出版物.
- 对人口多样性报告的种族和种族数据的评估.
主要成果:
- 在99项试验中,56%报告了种族和/或种族,报告在2017年之后增加.
- 大多数33,891名参与者是白人 (93%),黑人 (3%) 和亚裔 (0.2%) 人口的代表性不足.
- 在试验注册和出版物之间注意到术语和数据聚合的差异.
结论:
- 显著需要提高临床试验报告的透明度,准确性和代表性.
- 提高临床试验招生人数的多样性需要解决健康的社会决定因素.
- 积极的设计和报告策略对于将代表性不足的人群纳入多发性硬化症研究至关重要.
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