运行分散的临床试验:试验的技术见解@Home RADIAL概念验证试验
Sten Hanke1, Dimitrios Giannikopoulos2, Bernhard Neumayer1
1Institute of eHealth, FH Joanneum University of Applied Sciences, Graz, Austria.
Clinical pharmacology and therapeutics
|September 19, 2025
概括
分散临床试验 (DCT) 从模块化,多供应商技术中受益,但需要仔细整合和参与者支持. 本研究分享了关于选择和整合各种技术以实现高效的DCT实施的经验教训.
科学领域:
- 临床研究技术 临床研究技术
- 数字健康创新 数字健康创新
- 分散的临床试验 (DCT)
背景情况:
- 分散临床试验 (DCT) 提供了更好的可访问性和效率,但依赖于强大的技术基础设施和系统集成.
- 目前的DCT实现通常依赖于单一供应商的解决方案,限制了设计灵活性和互操作性.
- 一种模块化,多供应商的方法可以增强定制的试验设计和无的平台集成.
研究的目的:
- 介绍来自Trials@Home RADIAL概念验证试验的操作学习.
- 为DCT验证多供应商技术设置.
- 为DCT设计人员提供有关技术选择和集成的指导.
主要方法:
- 在RADIAL概念验证试验中实施一个模块化,多供应商技术包.
- 蓄意将核心系统 (如eConsent,蓝牙血糖计) 集成到一个中央平台中.
- 在中央系统以外的非核心组件的管理,以允许灵活性.
主要成果:
- 关键的挑战包括Bring Your Own Device (BYOD) 的变化,不成熟的设备技术和站点基础设施的局限性 (例如远程医疗).
- 投资参与者支持基础设施和早期跨职能协作至关重要.
- 自动化,多道通知可以提高参与者的参与度.
结论:
- 多供应商战略虽然具有挑战性,但允许定制的DCT设计和更好的互操作性.
- 早期规划合规和明确的治理模式简化了文档,提高了灵活性.
- 参与者支持和强大的技术整合对于成功实施DCT至关重要.
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