Research(Fig.1) Trans-departmental missionsof Clinical Research Education
Main Missions
1 . Goal-oriented clinical research education and human resource
development and their implementation
2 . Support for clinical research other than clinical trials andspecified clinical studies

G raduate S chool of Me dic ine , Na goya Unive r sity

Clinical Research Education : CRE
Professor of Clinical Research Education Department
Graduate School of Medicine

KATSUNO, Masahisa

Providing companion support to researchers
in order to disseminate research achievement
as well as educating clinical researchers
Within the medical field, clinical research is one of the most important
academic regions and plays an important role in the search for the causesof diseases, the development of new medical technologies, the formationof evidence necessary for the provision of optimal medical care, etc. In
the late 19th century, a cholera outbreak occurred around Broad Street inLondon, England. John Snow identified the vector pathway, and resolved
the situation by closing the well pump. At approximately the same time,
beriberi was widespread among the Japanese Navy. TAKAKI, Kanehiro
discovered the cause was due to a difference in their diet, and couldcontrol its spread by changing meal contents. These events opened theway to modern clinical research, which has become increasingly more
important especially in today's world as translational research, whichapplies basic research in life science to the clinical world, has gained
momentum. However, according to the data compiled by the Office ofPharmaceutical Industry Research, Japan ranks in 6th place in thenumber of papers published in major basic research journals (Nat Med,Cell, J Exp Med) by country during the two-year period of 2013-2014.
However, regarding the number of original papers published in majorclinical research journals (New Engl J Med, Lancet, JAMA) by country,
it ranks 19th. In order for clinical research in Japan to be steadily andappropriately promoted, it is essential, not only for each clinical122022

researcher to conscientiously engage in clinical research, but also
creating and maintaining a supportive environment for such researchers.
Under such conditions, Nagoya University Graduate School of Medicine
has established the Department of Clinical Research Education: CRE.
This department has been launched with the aim of improving research
literacy and enhancing the quality and quantity of research capabilities atNagoya University.
To enhance literacy in medical clinical research at Nagoya University,
the department performs two important missions, clinical researcheducation and support for clinical research (Fig.1). Regarding clinicalCRE

research education, activities began last year for medical school students
in the first year (Medical Science Cafe), fourth year (special lecture“Clinical Tral,”), fifth year (Clinical Training I), and sixth year (ClinicalTraining II). In addition, for graduate students and other clinicalresearchers with some degree of clinical experience and who areaffiliated with the University, “Introduction to the preparation ofprotocol for clinical trials” and “Clinical Research Seminar” have been
prepared as a place for practical education. In “Introduction to thepreparation of protocol for clinical trials” participants read ahypothetical clinical research plan and explanatory document inadvance, and then discuss points of improvement in a workshop styleenvironment. Although held online due to COVID-19, enthusiastic
discussions were held each time and the event has been well received byparticipants. The “Clinical Research Seminar” is held in cooperation
with the Department of Clinical Research Education, Department ofAdvanced Medicine, Tokai National Higher Education and Research
System/Center for Healthcare Information Technology(C-Hit), andthe Convolution of Informatics and Biomedical Sciences on GlobalAlliances (ClBoG). From “Clinical Research A to Z: From Planning toPublication” given in a lecture style, to “Planning Research Using
Electronic Medical Chart Information in Hospitals,” a participatory stylewhere each participant personally designs and prepares a research plan
outline and after which all participants seek to brush up the contents ofthe plan. The seminar was a complete success, with more than 30 people
consistently attending each time. This event will continue to be held in
the future, in recognition of the needs of the participants.
Core activities regarding “clinical research support” in clinical researcheducation include reviewing clinical research outlines for all new clinicalresearch subjects, and providing companion support for researchers. Asof October 2021, all research plan outlines for new clinical researchsubjects must be reviewed by the Department of Clinical Research
Education prior to submission to the Ethics Review Committee. Forresearchers, it means there is one more step before actual research
begins. However, this advance confirmation is expected to improve thereview process by the Bioethics Review Committee and enhance theoverall quality of clinical research conducted at Nagoya University.
The current, overall support system for clinical research at Nagoya
University is shown in Figure 2. Specifically, the Department of(In coordination with Department of Advanced Medicine）

3 . Clinical trial design according to the significance and purposeof the research, data quality control and guarantee
4 . Establishment of places for co-creation in clinical researchwhich transcend specialization, departments and positions（In cooperation with MIU and C-Hit）

Other Missions
5 . Establishment and maintenance of a registry/cohort and research activation (In cooperation with C-Hit)
6 . Implementation of clinical research as needed by society (including PPI）
7 . Degree acquisition by research support personnel
8 . Acquisition of leadership in domestic and international collaborations
9 . Response for diversification and digitalization of clinical research
10. Ensuring the sustainability of a fundamental system of research
MIU : Medical and Healthcare Innovation Unit
C-Hit : Tokai National Higher Education and Research System/ Center for Healthcare Information Technology
PPI : Patients and Public Involvement in Clinical Research

Advanced Medicine provides research support for clinical trials andspecified clinical studies, while the Department of Clinical Research
Education provides research support for other clinical research. The
Department of Clinical Research Education has organized anarrangement to support the needs of researchers from research planningand design to quality control and publication after research. This isreferred to as “companion support.” In fact, many researchers needsupport at various stages of clinical research, and meetings are held asneeded to assist such researchers in their steady advance in theirresearch.
Over time, the direction required for clinical research has rapidlychanged. Just looking ahead to the next 5 to 10 years, the list is endless,including strengthening cooperation between industry, government, andacademia, promoting preventive medicine and personalized medicine,
responding to the diversification of drug and medical device modalities,
and digitalization of clinical research, etc. In addition to basic clinicalresearch education for students and graduate students, the Department ofClinical Research Education will continue to take the lead in addressingissues related to clinical research by responding to the changes in times,
and striving to enhance the medical clinical research capability at
Nagoya University.

(Fig.2) Clinical research support system

Consultation

Clinical Trials/Specified Clinical Studies
Consultation

Researchersof eachdepartment

Consultation

Department of Advanced Medicine
Center for Advanced Medicine
and Clinical Research Data Center

Coordination

Companion support

ProtocolAdvice fora concept

Clinical trial
supportoperations

EDC, etc.
ARO operations

Practicalrealization

From development
toa clinical trial/specified clinical study

Working in collaboration with researchers from the early stages
in order to develop a research plan is important

Clinical Research Education
Other Clinical Research

Planning

DesignQuality Control
Progress
Management

Publication ofscientific papers

Companion support(including observational studies/registries)2022

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