Drug Evaluation Committee Survey and discussion on data utilization for jRCTs and clinical trial notifications toward implementation of ICH M11
Data Science Expert Committee
May 2026
In TF4-2 of the Data Science Subcommittee in FY2024 and FY2025, we have been studying the possibility of deployment to the design of operations based on the secondary use of clinical trial protocol (protocol) data in Japan, as ICH M11 has reached Step 4.
Currently, registration with jRCT (Japan Registry of Clinical Trials) and clinical trial notifications are mainly operated by manually entering and checking a lot of information based on protocol contents. This document summarizes the information that can be easily reused and the points that need to be adjusted and devised when protocols are structured according to ICH M11, and summarizes the points to be considered in practice.
We hope that the results of this review will help to inform future efforts and discussions on the promotion of DX in the clinical trial environment in the drug discovery ecosystem.