Annual Report 2018

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, Mitiko Suzuki, Sachiko Sakamoto, Kozi Takahasi, Maiko Takakusa, Hikari Sima

Data Management Section

Yuya Ikeda, Natuko Iwasaki, Ayako Sugama , Kyouko Tokita, Kaori Tobayama, Tukiko Higuchi, Nami Hirano, Seiko Matsuda, Akiomi Yoshida, Michio Ohono, Kei Ikeno, Kazuko Tsukamoto

Biostatistics Section

Shogo Nomura, Masahi Wakabayasi

Pharmacovigilance Section

Masato Yonemura, Noriko Fuzisiro, Kanae Kurashige

Information Technology Management Section

Yoshihiro Aoyagi

Translational Research Management Division

Katsuya Tsuchihara

Biobank Translational Research Support Section

Wataru Okamoto

Biobank Research Concierge

Akiko Nakayama

Translational Research Support

Izumi Miki, Yasutoshi Sakamoto

Research Sample Management Support

Yasuko Tada

Seeds Development Support Section

Katsuji Aikawa

Clinical Research Coordinating Division

Takayuki Yoshino, 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, Kyoko Tsuyuki, Hiromi Motoyanagi, Kazumi Yamaguchi, Yasuko Yoshihara, Kyoko Uehara, Noriko Noda, Yoshimi Fujiki, Junko Tsukada, Megumi Hodota, Rikako Tanaka, Megumi Futamura, Masami Sasaki, Mizuho Ibaraki, Aki Hashimoto, Mikina Takiguchi, Tomoko Matsumura, Atsuko Katagiri, Haruna Ariyoshi, Hikaru Matsuki, Masumi Kudo, Yoshimi Izumi, Minako Suzuki, Mayumi Nagino, Fumiko Kase, Tomoko Watanabe, Azusa Funaba, Mizuho Ibaraki, Misato Makishi, Ayae Minobe, Natshuko Takagi, Fumiko Arai, Ayaka Ishikawa, Keiko Abe, Aya Iwamoto, Ayaka Sakamoto, Saori Yokoba, Sayuri Nochi, Mari Takahashi, Kazumi Yamaguchi, Yasuko Yosihara

Introduction

 The Office of Clinical Research supports the clinical trial program 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 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.

Clinical trials

 Research Management Division:

- In 2018, ten Investigational new drug (IND) trials started their enrollment.

 Translational Research Management Division:

 We have supported the Nationwide Genome Screening Project: SCRUM-Japan since 2015, which had collected clinical and genomic data on more than 10,000 patients by the end of 2018.

 We supported ctDNA analysis (liquid biopsy) and international programs in 2018.

 We started 77 sponsored initiated clinical trials in 2018

Education

- On-the-job training for new staf

- 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.

Table 1. The number of company/investigator sponsored trials supported by the Clinical Research Coordinating Section in 2018