Developing and adopting safe and effective digital biomarkers to improve patient outcomes
Developing and adopting safe and effective digital biomarkers to improve patient outcomes
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DOI：
10.1038/s41746-019-0090-4
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发表时间：
2019-03-11
影响因子：
15.2
通讯作者：
Mandl, Kenneth D.
中科院分区：
文献类型：
--
作者：
Coravos, Andrea;Khozin, Sean;Mandl, Kenneth D.
生物标志物是作为正常生物过程、病理过程或对治疗干预的生物反应的指标而客观测量和评价的生理、病理或解剖特征。移动的数字连接技术的最新发展导致了一类新的生物标志物的出现，这些生物标志物是在硬件和软件的多个层面上测量的。以1和0量化，这些“数字”生物标志物可以支持临床环境物理范围之外的连续测量。这些产品的模块化软硬件组合为患者护理和生物医学研究创造了新的机会，实现了远程监控和分散式临床试验设计。然而，需要一种系统的方法来评估数字生物标志物的质量和效用，以确保其安全性和有效性之间的适当平衡。本文概述了数字生物标志物的开发和评估的关键考虑因素，研究了它们在临床研究和常规患者护理中的作用。
Biomarkers are physiologic, pathologic, or anatomic characteristics that are objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to therapeutic interventions. Recent advances in the development of mobile digitally connected technologies have led to the emergence of a new class of biomarkers measured across multiple layers of hardware and software. Quantified in ones and zeros, these "digital" biomarkers can support continuous measurements outside the physical confines of the clinical environment. The modular software-hardware combination of these products has created new opportunities for patient care and biomedical research, enabling remote monitoring and decentralized clinical trial designs. However, a systematic approach to assessing the quality and utility of digital biomarkers to ensure an appropriate balance between their safety and effectiveness is needed. This paper outlines key considerations for the development and evaluation of digital biomarkers, examining their role in clinical research and routine patient care.