Redefining and Validating Digital Biomarkers as Fluid, Dynamic Multi-Dimensional Digital Signal Patterns.
Redefining and Validating Digital Biomarkers as Fluid, Dynamic Multi-Dimensional Digital Signal Patterns.
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DOI：
10.3389/fdgth.2021.751629
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发表时间：
2021
影响因子：
--
通讯作者：
Paschalidis IC
中科院分区：
文献类型：
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作者：
Au R;Kolachalama VB;Paschalidis IC
“数字生物标志物”是一个广泛且不加区别地应用的术语，并且在其概念化方面通常限于模仿如由监管机构如美国食品和药物管理局（FDA）定义和批准的成熟生物标志物。现在迫切需要重新审视数字生物标志物的定义，并将其扩展到目前的识别和验证方法之外。将数字技术的承诺限制在目前定义的生物标志物领域内，会错失机会。由数据科学和人工智能驱动的一个全新的预后和早期诊断数字生物标志物领域可以打破目前由当今慢性病检测和治疗方法驱动的高医疗成本和低健康质量的循环。这一类新的数字生物标志物将是动态的，需要开发新的FDA批准途径和下一代黄金标准。
“Digital biomarker” is a term broadly and indiscriminately applied and often limited in its conceptualization to mimic well-established biomarkers as defined and approved by regulatory agencies such as the United States Food and Drug Administration (FDA). There is a practical urgency to revisit the definition of a digital biomarker and expand it beyond current methods of identification and validation. Restricting the promise of digital technologies within the realm of currently defined biomarkers creates a missed opportunity. A whole new field of prognostic and early diagnostic digital biomarkers driven by data science and artificial intelligence can break the current cycle of high healthcare costs and low health quality that is being driven by today's chronic disease detection and treatment approaches. This new class of digital biomarkers will be dynamic and require developing new FDA approval pathways and next-generation gold standards.