Trend of Digital Biomarkers (dBM) as Endpoints in Clinical Trials: Secondary Analysis of Open Data

This study examined clinical trial trends to guide digital biomarker (dBM) guideline development. Analysis of 2005-2023 data was conducted to assess the frequency and types of dBM used as endpoints (dEP) in these trials and the associated target diseases. Clinical trials using dEP increased from 0-7 per year (2005-2019) to 15-20 annually from 2020. Endocrine and metabolic conditions were the most common targets, showing a distinct disease distribution compared to overall trials. Most measurements used actigraphy devices or blood glucose sensors, with glucose sensors focusing on metabolic conditions while actigraphy covered broader applications. Additionally, 42.4% of trials used dEP as primary endpoints. While dEP use is growing, it remains limited in disease scope and device variety. Expanding both would enhance their utility in clinical research.