Annual Report 2023
Department of Clinical Development Promotion
Shigehiro Yagishita, Tomomi Yoshino, Makoto Ohno, Gou Okumura, Kazuki Yokoyama, Chikashi Watase, Yuki Kojima, Yuki Shinno, Hiroyuki Daiko, Daisuke Kurita, Konosuke Moritani, Naoya Toyoshima, Yasuhiko Mizuguchi, Ayumu Matsuda, Yasuhito Tanase, Suguru Fukushima, Dai Ogata, Suguru Fukuhara, Takashi Tanaka, Hiroto Ishiki, Takatoshi Hirayama, Yuko Yanai, Kae Okuma, Takeshi Iwasa, Takao Ueno, Hirotaka Matsui, Takafumi Koyama, Jun Sato, Yuki Katsuya, Mao Okada, Hiroki Nakayama, Reiko Makihara, Ikumi Iida, Kaori Shimada, Masataka Ueda, Tomoko Watanabe, Manami Matsukawa, Shun Yamamoto, Yukihiro Yoshida, Tatsuya Yoshida, Tsutomu Hayashi, Hidekazu Hirano, Seiichiro Abe, Hiroyuki Takamaru, Takeshi Takamoto, Daisuke Ban, Shuhei Osaki, Ayumu Arakawa, Eriko Satomi, Hiromichi Matsuoka, Shunsuke Sugawara, Chihiro Ito, Shintaro Kimura, Kuniko Sunami, Hiroki Kakishima, Satoyo Oda, Ryo Otsuka, Ami Takano, Yuya Kanai, Hiromi Suzuki, Yutaka Saito, Yuji Matsumoto, Yuta Maruki, Takashi Kubo, Chiaki Hayashi, Makoto Hirata, Yoshitaka Honma, Tatsunori Shimoi, Kazuki Sudo, Shunsuke Kondo, Taiki Hashimoto, Akinobu Hamada, Wataru Munakata, Ken Ohashi, Ken Kato, Hironobu Hashimoto, Kan Yonemori, Noboru Yamamoto
Introduction
Outline: In order to respond to the diversification of cancer treatment development, it is newly established in April 2023 with the goal of promoting and strengthening drug development, TR research, and medical device development, and it consists of three parts: Division of Drug and Diagnostic Development Promotion, Division of Translational Research Promotion, and Division of Medical Device Innovation Promotion. The missions of each division are as follows:
Division of Drug and Diagnostic Development Promotion: Planning and progress management of cross-organ-sectional research and clinical research conducted at the National Cancer Center Hospital, which mainly consists of members of medical departments and pharmacy departments, aims to conduct research/trials smoothly. It also serves as a window for the National Cancer Center when pharmaceutical companies plan and conduct clinical trials for new drugs across organs, with the goal of conducting rapid trials and involving patients. Develop a system within the hospital to promote clinical trials and clinical trials, such as the construction of a database that can be shared by each department and the sharing of clinical trial information within the hospital. In addition, by enhancing the collaboration among the departments of internal medicine, new trials and research on new ideas will be drafted and conducted without being trapped by each organ and department. In addition, in order to deepen the cooperation between hospitals for the purpose of referring patients to clinical trials, and to improve the literacy of medical personnel regarding clinical trials and clinical research, visits will be made to hospitals with a high number of patient referrals to this hospital, and workshops and seminars will be held.
Division of Translational Research Promotion consists of three sections: Translational Research Collaboration Support Section, Translational Research Specimen Control Section, and Translational Research Promotion Section. The Translational Research Collaboration Support Section is bridging the TR studies conducted as clinical studies in the Hospital when supported by the Research Institute, and supporting the management of bioresources collected in the Hospital. The Translational Research Specimen Control Section supports the logistics of TR researches utilizing patient-derived hematologic and tissue samples performed in the departments of the Hospital. The Translational Research Promotion Section promotes reverse TR in conjunction with clinicals and supports TR studies conducted by junior clinicians. It is composed of one director and five members.
Division of Medical Device Innovation Promotion: Based on the development of medical devices in conjunction with MIRAI project, it aims to be a world-class center for the development of minimally invasive treatments and medical devices by introducing AI and robotics technologies, to develop useful products for cancer patients regardless of whether they are medical devices or non-medical devices, and to make use of the ATLAS project's platform for international development. It has now begun with programmed medical devices and has been cross-sectionally promoting the development of novel medical devices in various clinical departments supported by MIRAI Project.
Research Activities
Division of Drug and Diagnostic Development Promotion: In fiscal 2023, 5 transdisciplinary international joint clinical trials were started. In order to promote the registration of clinical trials and clinical studies, six hospitals in the Kanto region were visited to introduce the clinical trials being conducted in our hospital, and the cooperation for the promotion of the referral of patients was strengthened. Support was provided for the planning and implementation of research on two clinical studies conducted in our hospital.
Division of Translational Research Promotion: The Translational Research Collaboration Support Section supported physician-initiated clinical trials and ancillary studies of clinical trials in fiscal 2023, including 1 respiratory medicine, 3 medical oncology, 3 pediatric oncology, 1 advanced care department, and 1 osteochondral oncology. In addition, by March 2024, a total of 2023 enrollments (108 cases/year) and 638 engraftments (63 cases/year) had been generated in J-PDx project to create a PDx modeling using patient-derived samples that could be collected with comprehensive consent and individual consent in the Hospital. The Translational Research Specimen Control Section supported 26 trials (eight starting in fiscal year 2024) as of March 2024. In collaboration with the Department of Laboratory Medicine, a system for managing blood collection tubes for research in the blood collection room was developed and improved, so that the patients themselves do not have to bring them, and blood collection is now performed more on schedule. Currently, we are preparing to assist with implementation planning such as prospective whole-genome analyses associated with JCOG trials. Translational Research Promotion Section provides support for 7 issues in fiscal 2023, and is preparing 14 studies for support in conjunction with the Research Institute FIOC.
Division of Medical Device Innovation Promotion: Beginning with programmed medical devices, we are promoting the development of new medical devices, including 11 in the Department of Endoscopy, 6 in IVR Center, 3 in the Department of Hepatobiliary and Pancreatic Surgery, 3 in the Department of Hepatobiliary and Pancreatic Oncology, 3 in the Department of Radiation Oncology and 3 in the Department of Musculoskeletal Oncology and Rehabilitation. The final milestones are from regulatory approval to commercialization and insurance reimbursement, respectively.
Education
The development of the next generation of development researchers is being carried out through medical care and research, which is not only in Japan but also globally. And, the training object is not limited to doctors, and it is made to be multi-occupation such as nurses, pharmacists, clinical laboratory technicians, etc.
Future Prospects
Recent development of cancer therapy is remarkably internationalized, diversified and accelerated, and its by-products can be called drug loss. In order to respond to the rapidly changing development of cancer treatments, we hope to promote human resource development while flexibly absorbing changes, and to lead the development of cancer treatments in Japan.