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关于在历史上代表性不足的群体中增强临床试验多样性的观点的多边定性研究

Matthew J DePuccio¹, Daniel Torrez², Elizabeth Hsu³

¹Department of Health Systems Management, Rush University, College of Health Sciences, Chicago, IL.

Clinical therapeutics

|July 8, 2025

概括

代表性不足的患者面临临临床试验参与的各种障碍,包括后勤问题和不信任. 建立良好的关系和信任是改善招聘和保留研究更多多样性的关键.

科学领域:

生物医学研究生物医学研究
医疗保健服务研究医疗服务研究
临床试验管理临床试验管理

背景情况:

在代表性不足的人群中招募临床试验是一个重大挑战.
发现急性至慢性疼痛过渡的生物标志物需要多样化的参与者数据.
利益相关者的观点对于理解和解决招聘障碍至关重要.

研究的目的:

确定影响代表性不足的患者参与临床试验的决定的因素.
描述不同患者群体参与的障碍和促进因素.
为改进临床试验招聘和保留人数的策略提供信息.

主要方法:

定性研究涉及47名参与者 (患者,医疗保健提供者,社区组织员工) 在美国中西部城市.
进行一对一的采访,记录,转录和归纳分析.
通过对参与者叙述的严格分析,确定了关键主题.

主要成果:

六个主要主题出现了:实际障碍,历史背景/理解力,沟通缺口,协议适应需求,关系/信任建设以及动机/益处.
常见的障碍包括后勤挑战和不信任;建立关系成为一个关键的推动因素.
不同的系统和个人因素影响参与.

结论:

代表性不足的患者参与是由多方面的障碍和推动因素塑造的.
在试验设计和实施中,让多个观点参与进来至关重要.
解决已识别的障碍可以增强参与者的多样性,并减轻招聘挑战.

关键词:

临床研究是临床研究.多样性的多样性多样性的多样性定性研究是指质量研究.代表性代表性的代表性社会经济因素社会经济因素代表性不足的少数民族.

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