改善临床试验招聘的系统框架:以文献为基础的方法
Blake Zimmerman1, Alexandria Moellner1, Nasia Safdar1,2
1Institute for Clinical and Translational Science, University of Wisconsin-Madison, Madison, WI, USA.
Journal of clinical and translational science
|February 16, 2026
概括
以参与者为中心的研究系统工程倡议 (SEIPR) 框架有助于研究人员改善临床试验参与. 它解决了障碍,并提供了解决方案,以增加代表性不足的人口的招聘和保留.
科学领域:
- 临床研究方法论临床研究方法论
- 医疗服务研究 医疗服务研究
- 患者参与策略 患者参与策略
背景情况:
- 在临床试验中招募和保留多样化的患者群体存在重大挑战.
- 了解阻碍或帮助参与的因素对于试验成功至关重要.
- 现有的框架需要调整,以满足以参与者为中心的研究需求.
研究的目的:
- 开发一个新的框架,以加强临床试验的招聘和保留.
- 为研究人员提供一个设计和评估更广泛参与试验的干预措施的工具.
- 为以参与者为中心的研究适应患者安全系统工程倡议 (SEIPS).
主要方法:
- 进行了PubMed和谷歌学者的一项非系统的文献审查.
- 确定了促进和阻碍代表性不足群体参与的因素.
- 根据文献发现,开发了以参与者为中心的研究 (SEIPR) 系统工程倡议框架.
主要成果:
- 主要障碍被分为五个组成部分:人,任务和工具,技术,物理环境和组织条件.
- 发现了一些常见的障碍,如缺乏意识,距离,有限的技术访问和不信任.
- 突出解决方案包括特定背景的推广,试验去中心化,通信技术,社区伙伴关系和财务/运输支持.
结论:
- SEIPR框架为增加临床试验参与者的多样性提供了一个结构化的方法.
- 该框架可以指导有针对性的干预措施的开发,实施和评估.
- 需要进一步的研究来评估SEIPR框架在不同人群中的实际有效性.
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