Developing and adopting safe and effective digital biomarkers to improve patient outcomes
Top Cited Papers
Open Access
- 11 March 2019
- journal article
- research article
- Published by Springer Science and Business Media LLC in npj Digital Medicine
- Vol. 2 (1), 1-5
- https://doi.org/10.1038/s41746-019-0090-4
Abstract
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.Keywords
Funding Information
- U.S. Department of Health & Human Services | National Institutes of Health (R01GM104303)
- Boston Children's Hospital, PrecisionLink Initiative
This publication has 19 references indexed in Scilit:
- Data mining for health: staking out the ethical territory of digital phenotypingnpj Digital Medicine, 2018
- FDA Regulation of Mobile Medical AppsJAMA, 2018
- Using Smartphones and Machine Learning to Quantify Parkinson Disease SeverityJAMA Neurology, 2018
- Wearable Devices in Clinical Trials: Hype and HypothesisClinical Pharmacology & Therapeutics, 2018
- Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO ConsortiumValue in Health, 2018
- Digital technologies as biomarkers, clinical outcomes assessment, and recruitment tools in Alzheimer's disease clinical trialsAlzheimer's & Dementia: Translational Research & Clinical Interventions, 2018
- The year of transition from research to clinical practiceNature Reviews Endocrinology, 2017
- The digitised clinical trialThe Lancet, 2017
- The midlife cognitive profiles of adults at high risk of late‐onset Alzheimer's disease: The PREVENT studyAlzheimer's & Dementia, 2017
- New dimensions and new tools to realize the potential of RDoC: digital phenotyping via smartphones and connected devicesTranslational Psychiatry, 2017