Annual Report 2018
Clinical Research Support Office
- Clinical Research Coordinating
Noboru Yamamoto, Miki Ito, Katsuaki Imaizumi, Noriko Kobayashi, Shinobu Araki, Katsuyuki Ikarashi, Yumiko Ikuno, Harue Ui, Shino Osawa, Hatsuki Ono, Ran Obara, Asako Kamikawa, Setsuko Kamizaki, Kikue Hasegawa, Hiroko Kawaguchi, Asako Sakamoto, Kayo Sawaki, Ai Sekido, Azumi Seko, Hiroko Takagi, Yukako Takasaki, Mari Takahashi, Maki Takayasu, Tomomi Tsuchiya, Rie Nagao, Yukari Nishiyama, Noriko Makita, Kazumi Matsuo, Chie Miyano, Sho Murata, Emi Yasuda, Yoshimi Yamaguchi, Tamami Yamano, Ai Kobayakawa, Mari Kondo, Hiroe Takayama, Ami Hashimoto, Kazumi Higuchi, Mayumi Miyamoto, Kimiko Sega, Chie Moteki, Ken Kato, Keiko Wakakuwa, Risa Miyagawa, Keiko Shimo, Harumi Mochizuki, Satomi Nakamori, Yuki Sako, Mayumi Ikeda, Nobuko Ushirozawa, Yoko Ebihara, Harumi Maruno, Junko Horie, Kaori Matsushita, Eiko Mitsumata, Yuka Higashi, Chiaki Yamamoto - Research Management Division
Kenichi Nakamura, Ayaka Ohmine, Sachi Nishikawa, Tomomi Hata, Makiko Watanabe, Mitsumi Terada, Laureline Gatellier, Natsuko Okita, Tamie Sukigara, Mamiko Kawasaki, Satoshi Kawashima, Hitomi Okuma, Naoko Matsui, Shoko Narita, Sae Ishimaru, Hiroshi Katayama, Eiko Yorikane, Sawako Tomatsuri, Sachie Kawabata, Kenta Anjo, Junko Eba, Keisuke Kanato, Tomohiro Kadota, Yuya Sato, Tomoko Kataoka, Yuko Takahashi, Taro Shibata, Aya Kuchiba, Junki Mizusawa, Gakuto Ogawa, Akihiro Hirakawa, Ryunosuke Machida, Ryo Sadachi, Chihiro Yaita - Data Management Division
Haruhiko Fukuda, Harumi Kaba, Mikio Mori, Nobuko Okamura, Takashi Makiuchi, Kaoru Koike, Keiko Ohata, Yukari Hoshina, Tomoaki Yamada, Masahisa Kamikura, Yukari Nagasaka, Eiko Sayama, Eru Adachi, Keiko Sutoh
Introduction
The Clinical Research Support Office supports clinical research conducted under the leadership of investigators in the National Cancer Center Hospital (NCCH). Support activities include protocol writing, central/local data management, statistical design and analysis, in-house/on-site monitoring, audits, patient recruitment, and other coordinating jobs.
The Team and What We Do
- Clinical Research Coordinating Division
The Clinical Research Coordinating Section and the Clinical Trial Administration Section support a lot of industry-sponsored registration trials as well as physician-initiated registrationdirected clinical trials. A total of 33 CRCs (clinical research coordinators), six CRC assistants, and seven administration staff support these trials.
The Biobank and Translational Research Support Section has routinely obtained informed consent to participate as an NCC biobank (NCCBB) donor from patients who consult with the NCCH for the first time. CRCs in this section coordinate translational research in several ways, such as assistance of registration for clinical trials, logistics of pathological specimens, data collection for case report forms, and coordination between sections. We explained the purport of the NCCBB to 9,986 patients from April 2018 to March 2019, and received consent for blood collection and research use of their surplus samples for research from 8,939 patients (89.5% consent proportion). The patient load with our assistance in filling in the preliminary-diagnosis card and so on was 10,379. We also support 12 biomarker studies, and for registered patients (pts), 82 pts for PRELUDE study, 34 pts for TOP- GEAR SciLabo, 331 pts for MASTER KEY project, 1,406 pts for micro RNA project, 11 pts for GISCREEN_CRC study, 11 pts for GI-SCREEN_ non CRC study, 36 pts for MASTER KEY HEM study, 8 pts for GI-SCREEN Registry, 7 pts for GISCREEN MSI, 20 pts for GOZILA study, 100 pts for MASTER KEY Guardant360 study and 275 pts for CiCLE study
- Research Management Division
The Research Management Division is in charge of central research support functions: i) International clinical trial management, ii) Investigational new drug (IND) trial management, iii) Monitoring & Consultation, iv) Multi-institutional clinical trial support, v) Biostatistics and vi) Pharmaceutical affairs consultation. One of the strengths of the NCCH is implementing various types of clinical trials covering both early phase trials including first-in-human trials and late phase multiinstitutional trials. The IND trial management function is responsible for comprehensive study coordination and site visit monitoring in early phase trials. The multi-institutional trial support function works as the Japan Clinical Oncology Group (JCOG) Operations Office which engages in protocol development, manuscript drafting, study coordination, and so forth for late phase trials.
- Data Management Division
The Data Management Division is responsible for central data management and inhouse study monitoring in investigator-initiated clinical trials for cancer therapeutic development. The Data Management Section supports early phase cancer trials mainly for drug development including registration trials which are led by physicians in the NCCH. The Multi-institutional Data Management Section supports mostly late development multi-modality multi-institutional phase II or phase III trials for adult solid cancer conducted by the JCOG.
Research activities
- Research Management Division
At academic conferences, several presentations were made by section members such as: i) NCCH initiative as a Clinical Research Core Hospital; ii) Issues and solutions to facilitate clinical trials under the Clinical Trials Act; iii) Project management of IND trials, Advanced Medical Care studies, Patient-proposed health services; and iv) Consent for biobanking of NCCBB.
Clinical trials
- Clinical Research Coordinating Division
The number of industry-sponsored registration trials is increasing year by year, and the division supported 406 registration-directed clinical trials including 37 investigator-initiated registration directed trials in FY 2018 (Table 1).
Table 1. Number of patients (April, 2018 - March, 2019)
Research Management Division
As of the end of 2018, the Research Management Division supported 18 IND trials, and nine clinical trials using the Advanced Medical Care System. This division has been in charge of the coordinating office of the rare cancer registry study with basket sub-studies (MASTER KEY Project). This division also supports an international investigator-initiated registrationdirected trial (PATHWAY trial). In addition, a clinical trial under Advanced Medical Care for NCC Oncopanel has been performed.
- Data Management Division
The Data Management Section supports 17 IND trials (ten open, three in preparation, four on follow-up) and 14 non-IND studies (eight open, three in preparation, three on follow-up). The Multi-institutional Data Management Section supports 83 non-IND trials (47 open, eight in preparation, 28 on follow-up) as the JCOG Data Center.
Education
The staff members received not only dayto-day on-the-job training but also in-house educational seminars and the JCOG internal educational programs in order to learn about clinical trial methodology, project management, monitoring, and research ethics.
Future prospects
- Clinical Research Coordinating Division
The number of supported clinical trials is increasing as previously described, and the supporting area covered by CRCs will be expanded to include not only registration trials but also other investigator-initiated clinical trials. Therefore, the expansion of CRC staff members is highly anticipated. In view of the plan for the NCCH, all members of this office will work together to contribute to reinforcing clinical research capabilities of the NCCH and to making this office a valuable unit for all members of our hospital.
The members of the Biobank and Translational Research Support Section presented seminars which are related to clinical research ethics, etc. The section informs and educates investigators of the NCC about the NCC biobank and translational research periodically through the NCC University. As a future direction, the section improves the quality of the NCC biobank's informatics and storage of serum. And the section aims to establish a support system for higher quality and quantity.
- Research Management Division
Since the number of IND trials has increased, reinforcement of staff resources is urgently needed. In response to this increase, this division will reinforce the support function for various clinical trials such as international clinical trials, IND trials, and advanced medical care system trials, and patient-proposed health services trials. Also, this division will establish optimal ways to cope with the newly enacted Clinical Research Act.
- Data Management Division
The Data Management Division is introducing a web-based electronic data capturing (EDC) system and is promoting standardization of all aspects of data management, such as data format, case report forms and monitoring reports for increasing data integrity, and cost effectiveness of day-to-day work.