Clinical Trials Act

On May 30, 2025, we held the first Academia Clinical Development Seminar online. For this session, we welcomed Dr. Kyoko Yaono from the Institute of Science Tokyo, who also serves as a Clinical Research and Development Technical Advisor at Research and Development Policy Division, Health Policy Bureau, Ministry of Health, Labour and Welfare. She delivered a lecture entitled "Overview of the Clinical Research Act."

She first described an overview of the background to the enactment of the Clinical Research Act and then explained in detail the following points of the amendments to the Act (which came into force on 31 May 2025), the main theme of this session, using specific examples.

[Law amendment]

- For research involving tests, etc. that place a significant burden on research subjects for research purposes

- Scope of specific clinical research on off-label use.

[Ministerial ordinance amendment]

- Concept of responsible entity for the entire research

- Appropriate conflict of interest reporting procedures

- Reporting deadlines for disease and other reports

- Accredited clinical research review committees

With regard to the appropriateness of the conflict-of-interest declaration procedure, it was noted that the COI database was not ready for this revision, but the system is currently being constructed.

After the lecture, a Q&A session was held with guest speaker Kento Asano, Deputy Director of the Academic Clinical Research Centre, Department of Medical Innovation, the University of Osaka Hospital, who serves as the secretariat of the Osaka University Ethics Review Committee.

The audience showed a high level of interest and asked many questions. Dr. Yaono answered each question succinctly, making it a valuable opportunity for the audience to have their doubts clarified.

We were fortunate to have Dr. Yaono give a talk at this time, just one day before the enforcement of the legal amendment. Thanks to this opportunity, we welcomed over 300 participants, making the event a great success.

The next Academia Clinical Development Seminar is scheduled for July 11. We look forward to welcoming you to the next seminar.