儿科急性中耳炎临床试验:对多样性的分析
Iman S Iqbal1, Elizabeth M Puyo1, Jonathan M Carnino1
1Boston University Chobanian and Avedisian School of Medicine, Boston, Massachusetts, USA.
概括
儿科急性中耳炎 (AOM) 试验显示,不同人群的代表性明显不足,大多数参与者是白人. 这突显了AOM研究的包容性存在关键差距.
科学领域:
- 儿科临床研究的临床研究.
- 临床试验的多样性和公平性
- 急性中耳炎 (AOM) 流行病学
背景情况:
- 对儿科急性中耳炎 (AOM) 的临床试验对于开发有效治疗方法至关重要.
- 确保AOM研究中的多样化参与者代表性对于普遍性和公平的医疗保健至关重要.
- 临床试验中人口统计报告的现有指导方针尚未完全解决包容性差距.
研究的目的:
- 评估在clinicaltrials.gov.gov上注册的儿科急性中耳炎 (AOM) 试验的多样性和公平性.
- 在AOM临床试验中识别人口代表性差距.
- 为提高未来儿科AOM研究的包容性制定策略.
主要方法:
- 完成的儿科AOM临床试验的回顾性分析,报告结果在ClinicalTrials.gov.gov上.
- 分析了48项独特的试验,重点关注参与者的人口统计 (年龄,性别,种族,种族) 和试验特征 (地点,赞助商/资助者).
- 评估关于种族和种族报告的数据完整性.
主要成果:
- 在AOM试验中,很大一部分没有充分报告种族 (43.7%) 和种族 (25%).
- 在分析的试验中,大多数参与者被确定为白人 (69.9%),这表明代表性的差异.
- 与国际和公共资助的试验相比,国内试验和私人资助的试验分别显示出更高的人口报告率.
结论:
- 儿科AOM临床研究迫切需要提高参与者多样性和更全面的人口统计报告.
- 尽管有指导方针,但在包容性方面仍然存在重大差距,需要集中努力.
- 在未来的AOM试验中优先考虑多样化的人群对于确保公平和普遍适用的医疗保健解决方案至关重要.
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