释放决策数字终点的全部潜力:一种新的模块化证据概念,使重复使用和推进合作成为可能
Lada Leyens1,2, John Batchelor1, Erwin De Beuckelaer3
1Regulatory Science, DEEP Measures Oy, Helsinki, Finland.
概括
数字健康技术为测量临床决策的患者功能提供了新的方法. 一个新的框架,数字证据生态系统和协议 (DEEP),使证据的再利用和数字终点的协作.
科学领域:
- 数字健康技术数字健康技术
- 患者功能测量测量患者功能测量
- 临床和监管决策的制定.
背景情况:
- 数字健康技术越来越多地测量患者的功能,支持临床试验和决策.
- 该领域正在迅速发展,提出了验证要求和新的监管指南.
- 制药公司正在积极合作开发数字终端.
研究的目的:
- 解决数字终点的漫长验证和监管接受过程.
- 提出一个新的模块化证据框架,用于重新利用数字测量解决方案和证据.
- 促进利益相关者之间的合作,包括卫生技术评估机构.
主要方法:
- 引入数字证据生态系统和协议 (DEEP) 框架.
- 为数字终端集成提供模块化堆模型的演示.
- 强调协调,透明和证据的再利用.
主要成果:
- DEEP 能够使测量解决方案的重新使用和证据的再利用.
- 模块化框架促进了协作和标准的应用.
- 拟议的模型加快了在患者护理中采用数字终点的速度.
结论:
- 像DEEP这样的模块化证据框架对于释放数字终点的全部价值至关重要.
- 协调和透明度对于将数字终点整合到医疗保健中至关重要.
- 拟议的方法促进合作,加快在个性化和远程护理中使用数字健康技术.
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