Annual Report 2020
Clinical Research Support Office
Research Management Division
Akihiro Sato
Project Management / Regulatory Affairs Management Section
Nozomu Fuse
Clinical Trial Management Section
Miki Fukutani, Hiromi Ono, Rena Sato, Hitomi Tamura, Masako Nakamoto, Makoto Fukui, Yuichi Mikamoto, Shinobu Iida, Mitiko Suzuki, Sachiko Sakamoto, Koji Takahashi, Maiko Takakusa
Data Management Section
Yuya Ikeda, Natsuko Iwasaki, Kyouko Hongo, Kaori Tobayama, Tsukiko Higuchi, Nami Hirano, Seiko Matsuda, Akiomi Yoshida, Kei Ikeno, Kazuko Tsukamoto, Koichi Asada
Biostatistics Section
Masashi Wakabayashi
Pharmacovigilance Section
Shinya Motonaga, Noriko Fujishiro, Kumiko Ozaki
Information Technology Management Section
Yoshihiro Aoyagi, Rie Terao
Translational Research Support Section
Hideaki Bando, Yoshiaki Nakamura, Takao Fujisawa, Izumi Miki, Satoshi Horasawa, Kana Kitajima, Naomi Kuramoto, Mihoko Yuasa, Hiroki Sokuoka, Tamami Nakamura, Yu Komura, Yasutoshi Sakamoto, Masayuki Hata, Hiroko Ichiki, Mayumi Fujita, Hiroshi Uchigata, Ryuta Mitani, Chie Murakami, Natsuko Honda
Clinical Research Coordinating Section
Masafumi Ikeda, Yoichi Naito, Kiyotaka Yoh, Takashi Kojima, Nobuaki Matsubara, Yasutoshi Kuboki, Takahiro Sakai, Yukie Kimura, Miyuki Hara, Yuko Ito, Ikumi Tamaki, Mayumi Shirase, Keiko Yamamoto, Chiyo Ito, Koko Komata, Aya Shinbu, Chiharu Hirano, Kiyoko Adachi, Keiko Abe, Rie Taniguchi, Hiromi Motoyanagi, Kazumi Yamaguchi, Yasuko Yoshihara, Kyoko Uehara, Noriko Noda, Yoshimi Fujiki, Junko Tsukada, Megumi Hodota, Rikako Tanaka, Megumi Futamura, Masami Sasaki, Aki Hashimoto, Tomoko Matsumura, Atsuko Katagiri, Haruna Ariyoshi, Hikaru Matsuki, Masumi Kudo, Yoshimi Izumi, Mayumi Nagino, Tomoko Watanabe, Azusa Funaba, Misato Makiishi, Ayae Minobe, Natsuko Takagi, Fumiko Arai, Aya Iwamoto, Ayaka Sakamoto, Saori Yokoba, Mari Takahashi, Shun Aoyagi, Akira Miyaura, Mariko Ishizuka, Hiromi Kawamura, Yasuko Fukushima, Miwa Chishiki, Yuki Suzuki, Mikayo Kutsuna, Hana Chou, Reiko Sugaya
Equipment Development Promotion Division
Shinichiro Takahashi
Equipment Development Promotion Section
Nobuyoshi Takeshita, Yuzuru Tomioka
Introduction
The Clinical Research Support Office supports the clinical trial programs conducted in the National Cancer Center Hospital East (NCCHE).
The Team and What We Do
Research Management Division:
Through the clinical datacenter, we support study management, site visit monitoring and gathering safety information and bio statistics.
Translational Research Support Section:
Mainly supports the secretariat and data center operations for multicenter clinical research.
Clinical Research Coordinating Division:
Mainly focuses on the first-in-human clinical trials as well as investigator-initiated innovative clinical trials for unmet medical needs.
Equipment Development Promotion Section:
Promotes equipment development through clinical trials and project management.
Research activities
Research Management Division:
In 2020, seven IND (Investigational new drug) trials started their enrollment.
Translational Research Support Section:
Supported a total of 32 clinical research projects. As large-scale multicenter studies, 1214 patients of solid or hematological malignancies were enrolled in MONSTAR-SCREEN, 1256 patients in GOZILA, 1408 patients in CIRCULATE-Japan, 618 patients in COSMOS, and 90 patients in HM-SCREEN. Six papers and 13 conference reports were presented, including a study published in Nature Medicine that showed the usefulness of liquid biopsy in advanced cancer. In addition, four new drugs and six diagnostics were approved using the SCRUM-Japan platform.
Education
- On-the-job training for new staff
- Supports educational programs for clinical trial methodology and GCP (Good Clinical Practice) in the NCC
- Clinical Trial Education programs for investigators in other institutions
Translational Research Support Section:
Ten staff members were certified as genome medical research coordinators in FY2020. In terms of retention management, we encouraged staff to join academic societies and acquire qualifications as part of education and training to improve their skills and prepare them for new projects.
Future Prospects
We aim to increase the capability of clinical trial support.
Translational Research Support Section
1. SCRUM-Asia was established as an overseas development of SCRUM-Japan, and cases have been registered from Taiwan. In addition, we are considering expanding to Korea, Singapore, and Australia in the next fiscal year.
2. MONSTAR-SCREEN-2, which is based on multi-omics data such as DNA/RNA analysis of tissues and blood, immunomultiplex staining, etc., has been prepared and case registration has been started on May 25, 2021.
List of papers published in 2020
Journal
1. Zenda S, Uchitomi Y, Morita T, Yamaguchi T, Inoue A. Establishment of a research policy for supportive and palliative care in Japan. Jpn J Clin Oncol, 51:538-543, 2021
2. Nakamura Y, Taniguchi H, Ikeda M, Bando H, Kato K, Morizane C, Esaki T, Komatsu Y, Kawamoto Y, Takahashi N, Ueno M, Kagawa Y, Nishina T, Kato T, Yamamoto Y, Furuse J, Denda T, Kawakami H, Oki E, Nakajima T, Nishida N, Yamaguchi K, Yasui H, Goto M, Matsuhashi N, Ohtsubo K, Yamazaki K, Tsuji A, Okamoto W, Tsuchihara K, Yamanaka T, Miki I, Sakamoto Y, Ichiki H, Hata M, Yamashita R, Ohtsu A, Odegaard JI, Yoshino T. Clinical utility of circulating tumor DNA sequencing in advanced gastrointestinal cancer: SCRUM-Japan GI-SCREEN and GOZILA studies. Nat Med, 26:1859-1864, 2020