Drug Evaluation Committee Utilization of and Requirements for Digital Biomarkers (dBM) in Drug Development
Clinical Evaluation Subcommittee
April 2022
With the development of information and communication technology, the utilization of medical-related real-world data obtained from various digital devices used in clinical trials has begun to be discussed, and further possibilities for drug development are being explored.
Task Force 1 of the Clinical Evaluation Subcommittee 2021 defined digital biomarkers as biological data (physiological and behavioral data) collected and measured objectively and quantitatively using digital devices for the purpose of clinical evaluation. In the subcommittee document, we summarized examples of the use of digital biomarkers in clinical trials and related laws, regulations, and guidance, as well as requirements and points to keep in mind when using them, with specific examples. We hope that this document will be of assistance when considering the introduction of digital biomarkers into clinical trials.
Utilization of Digital Biomarkers (dBM) in Drug Development and Requirements (1.2MB)