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Clinical Research Support Office
Department
Office of Clinical Research Support (OCRS)
Head of OCRS
Akihiro Sato
Introduction
The Office of Clinical Research Support consists of Research Management Division, Translational Research Management Division, Device Innovation Division and Clinical Research Coordinating Division. We support the investigator-initiated clinical trial program and translational research including a genome-wide screening network program conducted in the National Cancer Center Hospital East (NCCHE) .
Research Management Division:
The Team and What We Do
We support the clinical trials through the clinical data center, study management, site visit monitoring, safety information, and bio statistics.
Division Head
Akihiro Sato
Section & Manager
- Project Management / Regulatory Affairs Management Section: Nozomu Fuse
- Clinical Trial Management Section: Miki Fukutani
- Data Management Section: Yuya Ikeda
- Biostatistics Section: Shogo Nomura
- Pharmacovigilance Section: Shinya Motonaga
- Information Technology Management Section: Yoshihiro Aoyagi
Research Activities
40 IND(Investigational new drug) trials were started their enrollment since 2012.
Translational Research Management Division:
The Team and What We Do
We support the translational research including seeds development, biomarker discovery research, and development of in vitro diagnostics and companion diagnostics.
Division Head
Katsuya Tsuchihara
Section & Manager
- Translational Research Support Section: Hiroya Taniguchi
- Seeds Development Support Section: Katsuji Aikawa
Research Activities
We have supported Nationwide Genome Screening Project: SCRUM-Japan since 2015, and collected more than 10,000 patient’s clinical and genomic data in lung cancer and GI cancer until the end of 2018. We started the study support regarding translational research including ctDNA analysis (liquid biopsy) from 2017.
Device Innovation Division:
The Team and What We Do
We support research and development activities on innovative medical devices based on clinical needs in industry-academia-government and medical-engineering collaboration, in the NEXT Medical Device Innovation Center founded in the National Cancer Center Hospital East (NCCHE) in 2017.
Division Head
Shinichiro Takahashi
Research and Development Activities
We support the research and development activities focusing on artificial intelligence (AI) application to the medical field, a surgical robot, and a novel endoscopy system “Oxygen Saturation Imaging Endoscopy”. We also support the development of medical devices by matching the clinical needs with the seeds of technology.
Click here for details
https://www.ncc.go.jp/en/ncce/specialist_ctr_depts/NEXT_Medical_Device_Innovation_Center/index.html
The activities “Program on the site development for the creation of innovative medical devices in total cancer care” was adopted by the Japan Agency for Medical Research and Development (AMED) as a funding support program (2019-2023).
Clinical Research Coordinating Division:
The Team and What We Do
We mainly focuses on the first-in-human clinical trials as well as investigator initiated innovative clinical trials for unmet medical needs.
To conduct this innovative clinical trial, the clinical research coordinator is collaborating with each department in the hospital.
The goal is to achieve a high clinical trial environment internationally.
For this reason, we actively engage with medical facilities and pharmaceutical companies in Japan and overseas. This expands the field of view as a clinical research coordinator and aims to improve motivation.
Division Head
Takayuki Yoshino
Research Activities
Supported company or investigator sponsored trials in clinical research coordinating section in 2018 (see Table1)
| Phase | New (since 2017) | Ongoing |
|---|---|---|
| Phase I | 19 | 85 |
| Phase I/II | 4 | 19 |
| Phase II | 11 | 42 |
| Phase II /III | 3 | 3 |
| Phase III | 28 | 112 |
| Medical equipment | 0 | 2 |
| Regenerative medicine | 0 | 4 |
| IIT | 16 | 37 |
| Total | 81 | 304 |
Education
-On the job training for new staff
-Support the educational programs for clinical trial methodology and GCP (Good Clinical Practice) for NCC stuffs and other institution investigators.
Future prospects
-Preparation for conducting global IIT IND trials.
- Support for the development of innovative cellular immunotherapy clinical trials and highly novel medical devices from companies or academia.
- Exchanges of personnel between public and private