Annual Report 2023
Department of International Clinical Development
Kenichi Nakamura, Kan Yonemori, Yuka Okamoto, Sarah Kruschwitz, Tomomi Hata, Kazuko Ohara, Hiroko Nakahama, Hitomi Okuma, Chiharu Mizoguchi, Rina Inagaki, De Almeida Kathleen Yasmin, Ayako Miyata, Tomozo Yamada, Yuta Maruki, Yusuke Okuma, Masamichi Takahashi, Koichi Ogura, Kazuki Sudo, Shinji Kohsaka, Yuki Kojima, Sho Shiino, Hiroshi Yoshida, Keisuke Watanabe, Tomohiro Matsuda, Mitsumi Terada, Junya Yokobori, Nobuko Ushirozawa, Hisahiro Itoh, Jalutangsee Sukanya, Arthitada Hanada, Kittichai Theankham
Introduction
The Department of International Clinical Development (DICD) was established at the National Cancer Center Hospital in 2020 to accelerate international research, education, and treatment under an integrated vision, and to promote the Asian Clinical Trials Network for Cancers project (ATLAS project). In October 2023, the International Medical Care Section, previously part of the DICD, became an independent unit known as the Department of International Medical and Advanced Care.
The Team and What We Do
(International Professional Education Section)
In FY2023, as part of the ATLAS project, more than 50 English contents were published on the ICRweb, and the section solicited more overseas users for the educational contents. In collaboration with PMDA, a Multi-regional Clinical Trials Seminar in January 2024 was held for participants from overseas regulatory authorities and overseas medical institutions.
(International Research and Development Section)
In FY2023, the MASTER KEY project, a platform trial for rare cancers, was further expanded to Asian countries. In addition, an international collaborative study for biliary tract cancer, CHOICE, was conducted and a large-scale randomized controlled trial was launched across 6 Asian countries to evaluate the effectiveness of an AI-assisted diagnostic tool (CADe) in colonoscopy. The section also continued internal/external call for international clinical trials in Asia.
(International Translational Research Section)
In FY2023, patient accrual of A-TRAIN, a TR study of liquid biopsy in which 10 Asian countries participate, has been completed.. In addition, the section supported HARMONY study, an observational study using MRD technique in the field of breast cancer.
(Asian Partnerships Section)
As part of the ATLAS project, the NCC Asian Partnership Office has been established in Bangkok, Thailand, which has a local coordination function for international clinical studies and strengthen the network with local investigators, governments and regulatory authorities.
Research Activities
In FY2023, the ATLAS Board, consisting of representative investigators from 8 Asian countries, was established to discuss new research idea and various initiatives. Additionally, a Memorandum of Understanding (MoU) was signed with the Thai Ministry of Public Health to promote decentralized clinical trials (DCT) in both Japan and Thailand. This initiative was also presented at the Society of Clinical Trials in the United States. Furthermore, the activities of the ATLAS Project were presented at academic conferences both domestically and internationally.
Clinical Trials
Multiple international clinical studies are ongoing such as: PATHWAY, an investigator-initiated registration-directed trial for breast cancer; MASTER KEY ASIA, a platform study for rare cancer development; and A-TRAIN study, a TR study of liquid biopsy with 10 Asian countries; CHOICE, translational research of genomic medicine for cholangiocarcinoma; HARMONY, a translational research with MRD technique for breast cancer; and Project CAD, a large-scale randomized controlled trial which was launched across 6 Asian countries to evaluate the effectiveness of an AI-assisted diagnostic tool in colonoscopy.
Education
On-the-job training of international research support staff was made through coordination of international clinical studies. In addition, MRCT seminar was held jointly with PMDA for overseas regulators and researchers.
Future Prospects
DICD continues to promote the ATLAS Project and increase the number of international collaborative research. To this end, we will continue to call for new international research once every six months both within and outside the hospital. In addition, the contents of the ICRweb will be enhanced, and various educational seminars will be held jointly with other Asian countries.