应用系统思维来告知分散的临床试验规划和部署
Lidia Betcheva1, Jennifer Y Kim2, Feryal Erhun3
1Judge Business School, University of Cambridge, Cambridge, CB2 1AG, UK. lb702@jbs.cam.ac.uk.
Therapeutic innovation & regulatory science
|June 30, 2023
概括
分散临床试验 (DCT) 可以减少患者的负担,提高数据质量. 根据患者需求和试验具体情况定制DCT解决方案对于成功实施和在研究中更广泛的可访问性至关重要.
科学领域:
- 临床研究方法论临床研究方法论
- 医疗信息学 医疗信息学
- 系统科学 系统科学
背景情况:
- 越来越多的人对分散的临床试验 (DCT) 感兴趣,以应对临床开发中的挑战.
- 现有的问题包括参与者负担,访问和数据管理的复杂性.
- DCT为提高研究效率和包容性提供了潜在的解决方案.
研究的目的:
- 检查DCT解决方案对临床试验过程的整合和影响.
- 提出一个框架来评估使用系统思维的DCT.
- 确定克服DCT实施挑战的推动因素.
主要方法:
- 使用系统思维开发概念框架.
- 与DCT相关的利益相关者的痛点的反复评估.
- 分析DCT部署及其与现有系统的整合.
主要成果:
- DCT可以减轻参与者的负担,提高数据质量.
- 根据患者需求和试验要求定制DCT至关重要.
- DCT元素对现有的临床试验系统提出了新的要求.
结论:
- 分散的临床试验需要量身定制的方法,以实现最佳的患者参与和试验成功.
- 需要进一步的研究,以实证量化DCT的影响.
- 临床诊断技术有望使临床研究更容易获得,并与不同的人群相关.
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