Current status of the development of digital biomarkers (Preprint)

Abstract

BACKGROUND The emergence of digital biomarkers (DBM) has led to a breakthrough in traditional digital therapies, where indicators can be monitored and recorded remotely through sensors and hardware devices for therapeutic purposes such as disease prevention, diagnostic evaluation, and medication monitoring. OBJECTIVE The purpose of this study is to summarize the current status and results of the application of digital biomarkers, and to propose the shortcomings of current research and ways to cope with them, in order to further promote the development of digital biomarkers. METHODS The search in this study was limited to English publications. PubMed, Ovid MEDLINE, and Ovid EMBase databases were searched using keywords related to digital biomarkers, and the types of literature searched included journal papers, dissertations, conference papers, patents, scientific and technical results, and scientific and technical reports, etc. The search was limited to articles published before January 15, 2023. RESULTS After screening, de-duplicating and organizing the 24,733 retrieved documents, 92 articles were finally selected. The majority of studies focused on neurological disorders (55/92, 60%). Most of the acquisitions focused on gait (20/92, 22%) and daily activities (12/92, 13%). Use for disease assessment (22/92, 24%) and identification (16/92, 17%) were the most common intended uses of digital biomarkers. Most studies employ sensors (23/92, 25%) and smart devices (23/92, 25%), such as smartphones, smartwatches, and tablets, for data collection and recording. In addition, wearable devices (47/92, 51%) were the most common type of digital devices. CONCLUSIONS Thanks to the safety and reliability of digital biomarkers, they have more potential than traditional biomarkers and have a broader development prospect. In recent years, digital technology has been advancing, and digital biomarkers are currently a major trend in the field of medical research and have high clinical research value. However, since the current research is still in the early stage, and most digital biomarkers need to be networked for use, how to ensure data security and user privacy is also a major challenge to be cracked.