数字健康技术衍生临床试验终点的资格和接受的监管途径:赞助商的考虑
Jessie P Bakker1, Elena S Izmailova1, Aude Clement2
1Koneksa Health, New York, New York, USA.
Clinical pharmacology and therapeutics
|August 16, 2024
概括
基于传感器的数字健康技术 (sDHT) 为药物开发提供远程数据捕获,但存在监管障碍. 本综述比较了研究新药 (IND) 和药物开发工具 (DDT) 的途径,以帮助SDHT的采用.
科学领域:
- 数字医学 数字医学
- 监管科学 监管科学
- 临床试验 临床试验
背景情况:
- 基于传感器的数字健康技术 (sDHT) 越来越多地用于药物开发中的远程数据收集.
- 尽管投资,但由于监管复杂性,没有美国药物被批准使用sDHT衍生的初级终点.
研究的目的:
- 审查和比较美国sDHT衍生终点的两个主要调节途径.
- 为了指导制药赞助商在sDHTs的监管认可中进行导航.
主要方法:
- 研究新药 (IND) 应用途径的系统比较.
- 对药物开发工具 (DDT) 路径进行分析,以确定SDHT衍生终点的资格.
- 对SDHTs的证据要求和技术考虑的审查.
主要成果:
- IND途径需要针对特定药物的广泛证据,需要大量的专业知识和资源.
- 该DDT途径旨在使终点符合更广泛使用的生物标志物或临床结果评估的资格.
- sDHTs的监管地位对赞助商关于数据采集的决定产生重大影响.
结论:
- 了解IND和DDT路径的细微差别对于成功实施SDHT至关重要.
- 促进SDHTs的监管认可将加速其在临床研究中的部署.
- 本次审查旨在推进数字医学的监管科学,并支持SDHT的采用.
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