Annual Report 2021
Department of International Clinical Development
Kenichi Nakamura, Kan Yonemori, Kayo Motono, Yuuka Okamoto, Tatsunori Shimoi, Seiichiro Abe, Hiroshi Igaki, Miyuki Sone, Shunsuke Tsukamoto, Hiroko Nakahama, Tomomi Hata, Yoichi Osato, Miho Nakajima, Kazuko Ohara, Hitomi Okuma, Yuta Maruki, Yusuke Okuma, Masamichi Takahashi, Koichi Ogura, Chiharu Mizoguchi, Rina Inagaki, Kazuki Sudo, Shinji Kohsaka, Yuki Kojima, Sho Shiino, Hiroshi Yoshida, Keisuke Watanabe, Tomohiro Matsuda, Mitsumi Terada, Nobuko Ushirozawa, Hisahiro Itoh, Kumiko Yanagihara, Hitomi Otsuka, Jalutangsee Sukanya
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 an Asian clinical network project (the ATLAS Project).
The Team and What We Do
International Medical Care Section
In FY2021, as part of the ATLAS Project, several pieces of English content on genomic medicine and ISO15189 acquisition were uploaded to the ICR website. In collaboration with PMDA, a Multi-regional Clinical Trials Seminar was held in January 2022 for participants from overseas regulatory authorities and overseas medical institutions.
International Professional Education Section:
In FY2020, as part of the ATLAS project, English content on genomic medicine, ISO15189 acquisition, phase I trials, and CRC education was developed on the ICRweb. In collaboration with PMDA, a Multi-regional Clinical Trials Seminar was held in January 2021 for participants from overseas regulatory authorities and overseas medical institutions.
International Research and Development Section:
In FY2021, the MASTER KEY project was expanded to Asian countries. This is a platform trial for rare cancers, and as part of it, a genomic sequencing program was established with Asian countries including sample shipment, central pathological review, sample quality control, genomic sequencing, and reporting.
The section also called for applications for international clinical trials in Asia from investigators at NCCH.
International Translational Research Section:
In FY2021, patient accrual of the A-TRAIN study was started. This is a TR study of liquid biopsy in which 10 Asian countries will participate. In addition, an observational study using MRD techniques was prepared 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. It will function as a local coordinator for international clinical studies and strengthen the network with local investigators, governments and regulatory authorities.
Research activities
Multiple presentations on the activities of the ATLAS Project and DICD itself were given in several academic conferences, such as DIA, JSMO, and JSCTR.
Clinical trials
Multiple international clinical studies are ongoing (PATHWAY, an investigator-initiated registration-directed trial for breast cancer; MASTER KEY ASIA, a platform study for rare cancer development; and the A-TRAIN study, a TR study of liquid biopsy with 10 Asian countries). Three more international studies are under preparation for breast cancer, biliary tract cancer and pancreatic cancer.
Education
content have been uploaded to the ICR website. In collaboration with PMDA, a Multi-regional Clinical Trials Seminar was held in January 2022.
Future Prospects
We will continue to promote the ATLAS Project and increase the amount of international collaborative research. To this end, we will call for proposals for support for international research once every six months both within and outside the hospital. In addition, the content on the ICR website will be enhanced, and various educational seminars will be held jointly with other Asian countries.
List of papers published in 2021
Journal
1. Nakamura K, Ozawa H, Shibata T, Ushirozawa N, Hata T, Okita N, Fuse N, Sato N, Ikeda K, Hanaoka H, Maruyama T, Wada M, Shimizu S, Kasai H, Yamamoto Y, Sakurai J, Todaka K, Tashiro S, Yamamoto H. Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation. Therapeutic innovation & regulatory science, 56:220-229, 2022
2. Eba J, Nakamura K. Overview of the ethical guidelines for medical and biological research involving human subjects in Japan. Japanese journal of clinical oncology, 52:539-544, 2022
3. Okuma HS, Yonemori K, Kojima Y, Tanioka M, Sudo K, Noguchi E, Hijioka S, Wakakuwa K, Kato K, Hirakawa A, Kuchiba A, Kubo T, Ichikawa H, Yoshida A, Yatabe Y, Nakamura K, Mano H, Yamamoto N, Fujiwara Y. Clinical Utility of Circulating Tumor DNA in Advanced Rare Cancers. Frontiers in oncology, 11:732525, 2021