Evidence map›Paper›PMID 40445582›Full record

ArticleTherapeutic innovation & regulatory science2025

Diverse Roles and Characteristics of Academic Research Organizations in Japan: Results of A Questionnaire-Based Study.

Reo Tanoshima, Riki Tanaka, Koji Hara, Hironori Fukuoka, Tatsuya Haze, Naoko Inagaki, Akifumi Ijuin, Manabu Nitta, Yusuke Kobayashi, Kozo Okada and 4 more

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Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Reo TanoshimaYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University Hospital, Yokohama, Japan. reotano@yokohama-cu.ac.jp.
Riki TanakaBusiness Consultant, Yokohama City University Hospital, Yokohama, Japan.
Koji HaraGraduate School of Economics and Business Administration, Yokohama City University, Yokohama, Japan.
Hironori FukuokaYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University Hospital, Yokohama, Japan.
Tatsuya HazeYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University Hospital, Yokohama, Japan.
Naoko InagakiYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University Hospital, Yokohama, Japan.
Akifumi IjuinYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University Hospital, Yokohama, Japan.
Manabu NittaYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University Hospital, Yokohama, Japan.
Yusuke KobayashiYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University Hospital, Yokohama, Japan.
Kozo OkadaYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University Hospital, Yokohama, Japan.
Akito NozakiYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University Hospital, Yokohama, Japan.
Etsuko MiyagiYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University Hospital, Yokohama, Japan.
Tetsuya YamamotoYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University Hospital, Yokohama, Japan.
Takahisa GotoDepartment of Anesthesiology and Critical Care Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical trials in Japan are governed by three regulations: Japanese Good Clinical Practice (J-GCP), the Clinical Trials Act, and the Ethical Guidelines for Medical and Biological Research Involving Human Subjects. Academic research organizations (AROs) are non-profit entities established to support clinician-scientists in conducting rigorous and high-quality clinical trials. However, Japan's unique decentralized clinical trial system has resulted in relatively small AROs with diverse roles. Additionally, work style reforms among Japanese physicians pose challenges for allocating time to research. This study aimed to assess the demographics, activities, and roles of AROs in Japan.

methodsWe distributed a questionnaire survey to 31 AROs in Japan between October and December 2023. The survey collected data on organizational mission, vision, annual planning, clinical trial support, the number of supported studies, financial independence, and management of researchers' working hours.

resultsResponses were received from 20 AROs (64.5%), including five public university hospitals and two clinical research core hospitals. The median staff size was 26.7 (range: 2-80), with public university hospitals reporting a median of 22.6 (range: 1449). Y-NEXT had a larger staff size (53.4) compared with other public university hospitals but fewer than clinical research core hospitals (median: 78.5). Thirteen AROs (65.0%) reported having organizational missions, and 25.0% were financially independent. Effort allocation for staff varied among institutions, and six AROs (30.0%) managed researchers' working hours.

conclusionThe roles and ultimate goals of AROs vary across institutions, highlighting the need for alignment with each institution's clinical research priorities and principles.

Indexed as

Biomedical ResearchClinical Trials as TopicHumansJapanResearch PersonnelSurveys and QuestionnairesAcademic research organizationFinancial independenceMissionQuestionnaire surveyWork style reforms

Identifiers

PMID40445582

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.