Drug Evaluation Committee Utilization and Requirements for Digital Biomarkers (dBM) in Drug Development
April 2022
With the advancement of information and communication technology, discussions have begun regarding the utilization of real-world health data obtained from various digital devices used in clinical trials, and new possibilities for pharmaceutical development are being explored.
In the Clinical Evaluation Subcommittee’s FY2021 Task Force 1, for the purpose of clinical evaluation, we defined digital biomarkers as biological data (physiological and behavioral data) collected and measured objectively and quantitatively using digital devices, and conducted a study on their utilization.The subcommittee’s report summarizes examples of digital biomarker use in clinical trials, along with relevant laws, regulations, and guidance, and outlines the requirements and considerations for their use, incorporating specific case examples. We hope this document will be helpful for those considering the introduction of digital biomarkers into clinical trials.
Utilization and Requirements of Digital Biomarkers (dBM) in Drug Development (1.2MB)