Traditional and Digital Biomarkers: Two Worlds Apart?

TLDR

Biomarkers profoundly impact clinical practice, and the proliferation of digital devices has generated a new class of complex data, yet unclear definitions of digital biomarkers and their overlap with traditional ones impede discovery and validation. The study identifies current issues in digital biomarkers and proposes suggestions to address them. The authors organized a DayOne Workshop with academia and industry participants to discuss these issues. The authors identified similarities and differences between traditional and digital biomarkers, aligning semantics, defining unique features, reviewing regulatory procedures, and outlining novel precision‑medicine applications.

Abstract

The identification and application of biomarkers in the clinical and medical fields has an enormous impact on society. The increase of digital devices and the rise in popularity of health-related mobile apps has produced a new trove of biomarkers in large, diverse, and complex data. However, the unclear definition of digital biomarkers, population groups, and their intersection with traditional biomarkers hinders their discovery and validation. We have identified current issues in the field of digital biomarkers and put forth suggestions to address them during the DayOne Workshop with participants from academia and industry. We have found similarities and differences between traditional and digital biomarkers in order to synchronize semantics, define unique features, review current regulatory procedures, and describe novel applications that enable precision medicine.