Drug Evaluation Committee Survey and discussion on the use of data in jRCTs and clinical trial notifications for the implementation of ICH M11
May 2026
In fiscal years 2024 and 2025, Task Force 4-2 of the Data Science Subcommittee has been exploring the feasibility of designing operations in Japan that incorporate the secondary use of clinical trial protocol data, following ICH M11’s advancement to Step 4.
Currently, registration with the jRCT (Japan Registry of Clinical Trials) and clinical trial notifications primarily involve manually entering and verifying a large amount of information based on the protocol content.This document identifies information that would be easy to reuse if protocols were structured in accordance with ICH M11, as well as areas requiring adjustments and ingenuity, and summarizes practical considerations.
We hope that the results of this study will contribute to future initiatives and discussions aimed at promoting digital transformation (DX) in the clinical trial environment within the drug discovery ecosystem.