在医疗保健和临床试验中使用数字生物标志物的挑战和潜力
Johann K Lieberwirth1,2, Mirja Mittermaier3, Ariel Dora Stern4,5
1Hasso Plattner Institute, University of Potsdam, Potsdam, Germany. johann.lieberwirth@student.hpi.uni-potsdam.de.
Communications medicine
|February 21, 2026
概括
数字生物标志物利用传感器进行持续的健康监测和个性化医疗. 克服证据生成和监管方面的挑战可以将这些创新转化为标准的临床护理.
科学领域:
- 生物技术是生物技术.
- 数字健康数字健康
- 个性化医疗是个性化的医疗.
背景情况:
- 数字生物标志物利用传感器和分析技术进行持续的健康监测.
- 应用包括用于胰岛素优化的葡萄糖跟踪和用于心血管试验降低风险的可穿戴设备.
研究的目的:
- 描述数字生物标志物的现实世界使用案例.
- 讨论阻碍临床采用的障碍.
- 提出一条将数字生物标志物整合到标准护理中的途径.
主要方法:
- 对当前数字生物标志物应用的前景审查.
- 分析证据生成,监管审查,商业激励和数据表示方面的挑战.
- 建议解决方案,包括统一的资格,基于价值的报销和适应性证据循环.
主要成果:
- 数字生物标志物在优化治疗和提高临床试验效率方面表现有前途.
- 存在重大障碍,包括高的证据生成成本,冗余的监管流程,不足的商业激励和偏见的数据孤岛.
- 需要一个多方面的方法来弥合实验信号和临床实践之间的差距.
结论:
- 数字生物标志物为个性化医学和医疗保健提供了变革性的潜力.
- 解决开发,监管和补偿方面的系统性问题对于广泛采用至关重要.
- 拟议的框架旨在促进数字生物标志物的从研究到标准护理的过渡.
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