The proliferation of wearable devices and smartphones has made the collection of high-precision physiological and behavioral data increasingly commonplace. However, in Japan, the standards for utilizing this data as endpoints or evaluation metrics in medical and drug discovery settings, the approach to validity assessment, and the steps required for implementation remain insufficiently established.
　This study group brings together diverse perspectives—pharmaceutical companies, CROs, academia, and technology firms—to engage in focused discussions on key issues for the safe and effective utilization of digital biomarkers (dBM).