Developing and adopting safe and effective digital biomarkers to improve patient outcomes

TLDR

Biomarkers are measurable indicators of biological processes, and recent mobile digital technologies have created a new class of continuously measurable digital biomarkers that enable remote monitoring and decentralized clinical trials. The study calls for a systematic framework to evaluate digital biomarker quality and effectiveness, balancing safety and utility. The paper presents key considerations for developing and evaluating digital biomarkers, highlighting their roles in clinical research and routine patient care.

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.