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IMSUT HospitalCenter for Translational Research

トランスレーショナルリサーチ・治験センター
Professor
Fumitaka Nagamura, M.D., D.M.Sc.
Associate Professor
Masanori Nojima, M.D., Ph.D., M.P.H.
Project Associate Professor Hiroshi Yasui, M.D., Ph.D.

教 授
准教授
特任准教授

博士（医学）
博士（医学）
博士（医学）

長
野安

村
島井文
正孝
寛
寛

Our major mission is to support the conduct of clinical trials, especially for sponsorinvestigator clinical trial based on Translational Research (TR). Our roles on TR
varies from the advice for acquiring intellectual property, preparation for clinical
trials, assistance for conducting clinical trials, and so on. Our center consists ofcoordinator section, administrative section, data management/biostatistics section,and project management section

1. Promotion of Translational Research at IMSUT
Hospital
All members of staff.
We have an unwavering commitment to delivernovel therapies through the conduct of translational
research. To advance basic research findings into clinical application, we offer investigators the following
services:1)Planning research and development (R & D) strategies, including selecting target diseases, planning
product designs, and clarifying development pathways;2)Offering opportunities to consult an appointed patient attorney about the acquisition and maintenance of intellectual property rights as well as patent strategies;
3)Providing information necessary in the preclinicalphase of R & D, such as information on drug regulatory affairs and preclinical studies;4)Encouraging investigators to consult regulatory advisors of Pharmaceuticals and Medical Devices
Agency (PMDA) in a timely manner;
5)Participating in investigator-regulator meetings to
help investigators deal with the issues pointed outin the meetings;

6)Advising on clinical trial design so that feasible andscientifically appropriate trials are conducted;7)Reviewing clinical study protocols, consent forms,and related documents in prior to Institutional Review Board examination to ensure the quality ofclinical trials conducted at IMSUT Research Hospital;
8)
Assigning Translational Research Coordinators(TRCs) to each translational research project in theclinical trial phase; TRCs help patients participating
in clinical trials to understand study protocols andto cope with negative emotions including fear, confusion, and depression; TRCs assist investigators
2.  Statistics and Quality control in Clinical Trials
Masanori Nojima, Motoki Amai, Mitsumi Tokunaga, Fumitaka Nagamura
We have planned and performed data management, monitoring, and statistical works in clinical trials.
[Data management]: Planning, EDC and CRF
preparation, registration, allocation, database management, data cleaning, coding[Monitoring]: Monitoring for drug management[Statistics]: Planning and perform for statistical290
analyses, Sample size calculation.
3.  Support for the investigator-initiated clinical
trials under an Investigational New Drug Application
All members of staff
Our mission is to develop efficient approaches for
conducting investigator-initiated clinical trials under
Investigational New Drug application (IND) to promote translational research. In 2023, we supported
four sponsor-investigator clinical trials by site management as well as project management. These four
clinical trials were: oncolytic virus for malignant melanoma, phase II clinical trial with novel gene-induced
adjuvant cells for acute myelogenous leukemia, administration of vaccine against the COVID-19 infection, and dendritic cell therapy for ATLL.
4. Management of “Translational Research Network Program” of Japan Agency for Medical
Research and Development.
Miwako Okada, Fumitaka Nagamura

Ministry of Education, Culture, Sports, Scienceand Technology launched “Translational Research
Network Program” to promote translational researchbased on the results of basic science in academia. This
program was transferred to Japan Agency for Medical
Research and Development in 2015 and has been expected to support TRs from basic science to seek obtaining intellectual property to the early stage of clinical trial. In 2023, we supported 27 basic researches(24: other than IMSUT), 17 preclinical studies (12: other than IMSUT), and 11 clinical studies (4: other thanIMSUT) under this program. The number of studies
we assist has been increasing year by year. Efficient
operation of the organization is required.
5.  Statistical consulting for basic research
Masanori Nojima
Consulting for study design and statistical analysis in any type of clinical research including clinicalresearch, basic medical/biological research. We havecollaborated with other members in IMSUT and otherinstitutions through the consulting.

Publications
1.		Motoki Amai, Masanori Nojima, Yoshikazu Yuki,Hiroshi Kiyono, Fumitaka Nagamura. A review ofcriteria strictness in “Toxicity Grading Scale for
Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials”. Vaccine. 2023 Aug 31;41(38):5622-5629. doi: 10.1016/j.
vaccine.2023.07.072. Epub 2023 Aug 1.
2.		Tokiko Nagamura-Inoue , Fumitaka Nagamura .
Umbilical cord blood and cord tissue banking as
somatic stem cell resources to support medical cellmodalities. Inflamm Regen 2023 Dec 5;43(1):59.
doi: 10.1186/s41232-023-00311-4.
3.		Tokiko Nagamura-Inoue, Seiko Kato, Yuho Najima, Masamichi Isobe, Noriko Doki, HisashiYamamoto, Naoyuki Uchida, Atsuko Takahashi,Akiko Hori, Masanori Nojima, Kazuteru Ohashi,Fumitaka Nagamura, Arinobu Tojo. Immunological influence of serum-free manufactured umbilical cord-derived mesenchymal stromal cells forsteroid-resistant acute graft-versus-host disease.
Int J Hematol. 116(5):754-769, 2023.
4.		Nogami K, Fujii T, Sawada A, Nagao A, Nagae C,Nojima M, Suzuki N, Nosaka D, Shimura T, Sugao
Y, Amano K. Association of physical activity withbleeding events and safety in patients with haemophilia A starting emicizumab prophylaxis: aninterim analysis of the TSUBASA study. Int J He-matol. 2023 Dec 15. doi: 10.1007/s12185-023-036798. Epub ahead of print. PMID: 38100026.
5.		Nagao A, Chikasawa Y, Sawada A, Kanematsu T,
Yamasaki N, Takedani H, Nojima M, Fujii T, Suzuki N, Matsushita T, Higasa S, Amano K; ADVANCE Japan Working Group. Haemophilia andcardiovascular disease in Japan: Low incidence
rates from ADVANCE Japan baseline data. Haemophilia. 2023 Oct 8. doi: 10.1111/hae.14876. Epubahead of print. PMID: 37806778.
6.		Watanabe K, Nojima M, Nakase H, Sato T, Matsuura M, Aoyama N, Kobayashi T, Sakuraba H,Nishishita M, Yokoyama K, Esaki M, Hirai F, Nagahori M, Nanjo S, Omori T, Tanida S, Yokoyama
Y, Moriya K, Maemoto A, Handa O, Ohmiya N,Tsuchiya K, Shinzaki S, Kato S, Uraoka T, Tanaka
H, Takatsu N, Nishida A, Umeno J, Nakamura M,Mishima Y, Fujiya M, Tsuchida K, Hiraoka S, Okabe M, Toyonaga T, Matsuoka K, Andoh A, Hirota
Y, Hisamatsu T; J-COMBAT study group. Trajectory analyses to identify persistently low responders to COVID-19 vaccination in patients with inflammatory bowel disease: a prospective
multicentre controlled study, J-COMBAT. J Gastroenterol. 2023 Aug 10. doi: 10.1007/s00535-02302029-z. Epub ahead of print. PMID: 37561155.