Annual Report 2019

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, Sakiko Kuroda, Rena Sato, Hitomi Tamura, Masako Nakamoto, Makoto Fukui, Yuichi Mikamoto, Shinobu Iida, Michiko Suzuki, Sachiko Sakamoto, Koji Takahashi, Maiko Takakusa, Hikari Shima

Data Management Section

Yuya Ikeda, Natsuko Iwasaki, Kyouko Tokita, Kaori Tobayama, Tsukiko Higuchi, Nami Hirano, Seiko Matsuda, Akiomi Yoshida, Michio Ohono, Kei Ikeno, Kazuko Tsukamoto. Koichi Asada

Biostatistics Section

Shogo Nomura, Masahi Wakabayashi, Gakuto Ogawa

Pharmacovigilance Section

Shinya Motonaga, Noriko Fujishiro, Kumiko Ozaki

Information Technology Management Section

Yoshihiro Aoyagi, Rie Terao

Translational Research Management Division

Katsuya Tsuchihara

Translational Research Support Section

Hiroya Taniguchi, Yoshiaki Nakamura, Hiroko Ichiki, Satoshi Horasawa, Izumi Miki, Yasuko Tada, Yasutoshi Sakamoto, Hiroki Saokuoka, Masayuki Hata, Hiroshi Uchigata, Hitomi Nakai, Kana Kitajima, Mihoko Yuasa, Natsuko Honda, Fusako Suzuki.

Seeds Development Support Section

Katsuji Aikawa, Masateru Iizuka

Clinical Research Coordinating Division

Takayuki Yoshino

Clinical Research Coordinating Division

Masafumi Ikeda, Yoichi Naito, Kiyotaka Yoh, Takashi Kojima, Nobuaki Matsubara, Yasutoshi Uboki, 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 Makishi, Ayae Minobe, Natsuko Takagi, Fumiko Arai, Aya Iwamoto, Ayaka Sakamoto, Saori Yokoba, Mari Takahashi, Shun Aoyagi, Akira Migaura, 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, Tomoo Yamamoto

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 Management Division:

 We support the translational research including seeds development, biomarker discovery research, and development of in vitro diagnostics and companion diagnostics.

 The 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:

 We promote equipment development through clinical trials and project management.

Clinical trials

 Research Management Division:

- In 2019, ten IND (Investigational New Drug) trials started their enrollment.

 Translational Research Management Division:

 We have supported the Nationwide Genome Screening Project: SCRUM-Japan since 2015. It had collected clinical and genomic data on more than 17,000 patient by the end of 2019.

 We supported regarding ctDNA analysis (liquid biopsy) and international programs in 2019.

 We started 87 sponsor-initiated clinical trials in 2019.

Education

- On the job training for new staff

- Support educational programs for clinical trial methodology and GCP (Good Clinical Practice) in the NCC

- Clinical Trial Education programs for other institutions’ investigators.

Future prospects

- Increasing clinical trial support capabilities.