Clinical Research Knowledge of Medical Graduates in Japan: A Pilot Study

Clinical Research Knowledge of Medical Graduates in Japan: A Pilot Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Clinical Research Knowledge of Medical Graduates in Japan: A Pilot Study Miwa Sekine, Yuji Nishizaki, Nobuhiko Horioka, David Aune, Shoji Sanada, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7699884/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 7 You are reading this latest preprint version Abstract Background: Clinical research education is critical for cultivating physician-scientists and ensuring evidence-based practice. However, the extent to which newly graduated physicians in Japan possess clinical research competencies remains unclear. Methods: A cross-sectional survey was conducted between April and May 2024 among 458 postgraduate year-zero (PGY0) resident physicians in Japan. Participants completed five clinical research knowledge questions selected from a validated 48-item assessment tool. The responses from PGY0 residents were newly collected for this study, while comparative data from principal investigators and clinical research support staff were drawn from previously collected datasets and reanalyzed here at the item level. Subgroup analyses were conducted based on university type and designation as a clinical research core hospital. Results: Only 37.7% of PGY0 residents correctly answered a question on the research process, compared to 75.0% of principal investigators and 94.4% of support staff, based on data collected in a previous study. The highest correct answer rate among PGY0 residents was 77.9% for a question on managing conflicts of interest; however, it still trailed the comparison groups. Correct rates on the remaining items ranged from 53.7% to 73.2%, while both comparison groups exceeded 75% for all items. Graduates of schools affiliated to clinical research core hospitals scored significantly higher than others (p = .011). Conclusions: The findings indicate substantial gaps in clinical research knowledge among newly graduated physicians and underscore the need for improved undergraduate training. Structured curricula and early postgraduate training that include hands-on, project-based research are vital for developing physician-investigators and enhancing Japan’s global research contributions. postgraduate physicians medical graduates principal investigators clinical research physician-led clinical trials research integrity knowledge Japan Full Text Additional Declarations Competing interest reported. Yuji Nishizaki received an honorarium from the Specified Nonprofit Corporation of the Japan Institute for Advancement of Medical Education Program (JAMEP) for serving as project manager. Yasuharu Tokuda served as a board member (unpaid) and received honoraria from the JAMEP for lectures and for serving as an examination development committee member. The other authors have no conflicts of interest to declare. Supplementary Files SupplementaryTableS1.docx SupplementaryTableS2.docx AnonymizedPGY0Knowledge.xlsx AppendixClinicalResearchQuestionsCorrected.docx STROBEchecklistcrosssectionalcompleted.docx Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 10 Dec, 2025 Reviewers agreed at journal 08 Dec, 2025 Reviewers invited by journal 28 Nov, 2025 Editor invited by journal 13 Oct, 2025 Editor assigned by journal 11 Oct, 2025 Submission checks completed at journal 11 Oct, 2025 First submitted to journal 24 Sep, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7699884","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":552758063,"identity":"048559d0-7386-4c9e-9f83-2b22220f9513","order_by":0,"name":"Miwa Sekine","email":"","orcid":"","institution":"Juntendo University Faculty of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Miwa","middleName":"","lastName":"Sekine","suffix":""},{"id":552758064,"identity":"1f98752d-a0a0-4fae-9abe-6ea5a444ef76","order_by":1,"name":"Yuji 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Yuji Nishizaki received an honorarium from the Specified Nonprofit Corporation of the Japan Institute for Advancement of Medical Education Program (JAMEP) for serving as project manager. Yasuharu Tokuda served as a board member (unpaid) and received honoraria from the JAMEP for lectures and for serving as an examination development committee member. The other authors have no conflicts of interest to declare.","formattedTitle":"Clinical Research Knowledge of Medical Graduates in Japan: A Pilot Study","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-medical-education","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"meed","sideBox":"Learn more about [BMC Medical Education](http://bmcmededuc.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/meed/default.aspx","title":"BMC Medical Education","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"postgraduate physicians, medical graduates, principal investigators, clinical research, physician-led clinical trials, research integrity knowledge, Japan","lastPublishedDoi":"10.21203/rs.3.rs-7699884/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7699884/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e Clinical research education is critical for cultivating physician-scientists and ensuring evidence-based practice. However, the extent to which newly graduated physicians in Japan possess clinical research competencies remains unclear.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e A cross-sectional survey was conducted between April and May 2024 among 458 postgraduate year-zero (PGY0) resident physicians in Japan. Participants completed five clinical research knowledge questions selected from a validated 48-item assessment tool. The responses from PGY0 residents were newly collected for this study, while comparative data from principal investigators and clinical research support staff were drawn from previously collected datasets and reanalyzed here at the item level. Subgroup analyses were conducted based on university type and designation as a clinical research core hospital.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e Only 37.7% of PGY0 residents correctly answered a question on the research process, compared to 75.0% of principal investigators and 94.4% of support staff, based on data collected in a previous study. The highest correct answer rate among PGY0 residents was 77.9% for a question on managing conflicts of interest; however, it still trailed the comparison groups. Correct rates on the remaining items ranged from 53.7% to 73.2%, while both comparison groups exceeded 75% for all items. Graduates of schools affiliated to clinical research core hospitals scored significantly higher than others (p = .011).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions:\u003c/strong\u003e The findings indicate substantial gaps in clinical research knowledge among newly graduated physicians and underscore the need for improved undergraduate training. Structured curricula and early postgraduate training that include hands-on, project-based research are vital for developing physician-investigators and enhancing Japan’s global research contributions.\u003c/p\u003e","manuscriptTitle":"Clinical Research Knowledge of Medical Graduates in Japan: A Pilot Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-01 07:32:02","doi":"10.21203/rs.3.rs-7699884/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2025-12-10T20:40:25+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"327985274053663744371507747542231284070","date":"2025-12-08T20:27:16+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-11-28T10:59:32+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-10-13T05:38:12+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-11T07:31:51+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-10-11T07:29:12+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Medical Education","date":"2025-09-24T05:58:01+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-medical-education","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"meed","sideBox":"Learn more about [BMC Medical Education](http://bmcmededuc.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/meed/default.aspx","title":"BMC Medical Education","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f9a50083-bef2-4f5f-8fa2-c82ee09bf561","owner":[],"postedDate":"December 1st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-12-01T07:32:02+00:00","versionOfRecord":[],"versionCreatedAt":"2025-12-01 07:32:02","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7699884","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7699884","identity":"rs-7699884","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}