{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T15:13:16Z","timestamp":1783782796843,"version":"3.55.0"},"reference-count":16,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T00:00:00Z","timestamp":1776988800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T00:00:00Z","timestamp":1776988800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["JP25zf0227104"],"award-info":[{"award-number":["JP25zf0227104"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Clin Oncol"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Real-world data (RWD) and real-world evidence (RWE) are increasingly important in oncology, where randomized controlled trials often exclude elderly patients, those with comorbidities, and rare cancer subtypes. To meet the need for high-quality oncology RWD in Japan, the J-CONNECT Consortium was launched to build a multiinstitutional database of chemotherapy-treated solid cancer patients using electronic medical records (EMRs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data were collected from 12 Ministry of Health, Labour and Welfare\u2013designated cancer care hospitals, with expansion to 15 institutions planned by 2026. J-CONNECT links hospital cancer registry information with EMRs, capturing demographics, staging, treatments, laboratory results, and biomarkers. Coverage and distributional characteristics were evaluated by comparing distributions with the National Hospital-based Cancer Registry by cancer site, age, and sex.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The database included 51,497 patients diagnosed after 2018. Major cancer groups were breast (12,363), lung (6743), prostate (5235), colorectal (4012), pancreas (3720), stomach (2383), esophagus (1960), and liver (1731). Sex distributions were consistent with national data, while some variability was observed by age.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>J-CONNECT is a robust oncology database in which clinical and biomarker variables are available, although completeness may vary; fitness-for-purpose should be assessed on a study-by-study basis. Coverage and distributional characteristics and also regulatory acceptance highlight its value for research, PMS, and policy. Future directions include expansion to 25 hospitals, integration of outcome and resource-use data, and adoption of common data models for broader collaboration. We believe J-CONNECT provides valuable oncology data supporting research, post-marketing surveillance, and public health policy in Japan.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10147-026-03011-4","type":"journal-article","created":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T13:34:52Z","timestamp":1777037692000},"page":"931-939","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Introducing the J-CONNECT database: a real-world oncology resource for Japan"],"prefix":"10.1007","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7715-5292","authenticated-orcid":false,"given":"Masafumi","family":"Okada","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shigemi","family":"Matsumoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuriko","family":"Maehara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoko","family":"Kanayama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitra","family":"Lambrelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadashi","family":"Koga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manabu","family":"Muto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,4,24]]},"reference":[{"issue":"5","key":"3011_CR1","doi-asserted-by":"publisher","first-page":"e746","DOI":"10.1634\/theoncologist.2019-0647","volume":"25","author":"M Di Maio","year":"2020","unstructured":"Di Maio M, Perrone F, Conte P (2020) Real-world evidence in oncology: opportunities and limitations. Oncologist 25(5):e746\u2013e752. https:\/\/doi.org\/10.1634\/theoncologist.2019-0647","journal-title":"Oncologist"},{"key":"3011_CR2","unstructured":"Oncology Center of Excellence. Oncology Real-World Evidence Program. U.S. Food & Drug Administration (2025) https:\/\/www.fda.gov\/about-fda\/oncology-center-excellence\/oncology-real-world-evidence-program Accessed 23 Oct 2025"},{"issue":"7","key":"3011_CR3","doi-asserted-by":"publisher","first-page":"858","DOI":"10.1016\/j.jval.2017.03.008","volume":"20","author":"A Makady","year":"2017","unstructured":"Makady A, Ham RT, de Boer A et al (2017) What is real-world data? A review of definitions based on literature and stakeholder interviews. Value Health 20(7):858\u2013865. https:\/\/doi.org\/10.1016\/j.jval.2017.03.008","journal-title":"Value Health"},{"issue":"9","key":"3011_CR4","doi-asserted-by":"publisher","first-page":"867","DOI":"10.1001\/jama.2018.10136","volume":"320","author":"J Corrigan-Curay","year":"2018","unstructured":"Corrigan-Curay J, Sacks L, Woodcock J (2018) Real-world evidence and real-world data for evaluating drug safety and effectiveness. JAMA 320(9):867\u2013868. https:\/\/doi.org\/10.1001\/jama.2018.10136","journal-title":"JAMA"},{"issue":"8","key":"3011_CR5","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13903","volume":"17","author":"G Alipour-Haris","year":"2024","unstructured":"Alipour-Haris G et al (2024) Real-world evidence to support regulatory submissions: a landscape review and assessment of use cases. Clin Transl Sci 17(8):e13903. https:\/\/doi.org\/10.1111\/cts.13903","journal-title":"Clin Transl Sci"},{"issue":"1","key":"3011_CR6","doi-asserted-by":"publisher","first-page":"283","DOI":"10.1002\/cpt.2453","volume":"111","author":"DR Rivera","year":"2022","unstructured":"Rivera DR et al (2022) The Friends of Cancer Research real\u2010world data collaboration pilot 2.0: methodological recommendations from oncology case studies. Clin Pharmacol Ther 111(1):283\u2013292. https:\/\/doi.org\/10.1002\/cpt.2453","journal-title":"Clin Pharmacol Ther"},{"key":"3011_CR7","unstructured":"Pharmaceuticals and Medical Devices Agency (PMDA) (2014) Guidelines for the conduct of pharmacoepidemiological studies in drug safety assessment with medical information databases. https:\/\/www.pmda.go.jp\/files\/000240951.pdf. Accessed 23 Oct 2025"},{"key":"3011_CR8","unstructured":"Ministry of Health, Labour and Welfare (MHLW) (2018) Points to consider for ensuring the reliability of post-marketing database study for drugs. https:\/\/www.pmda.go.jp\/files\/000243808.pdf Accessed 23 Oct 2025"},{"key":"3011_CR9","unstructured":"Ministry of Health, Labour and Welfare (MHLW) (2021) Basic principles on utilization of registry for applications. https:\/\/www.pmda.go.jp\/files\/000240810.pdf. Accessed 23 Oct 2025"},{"key":"3011_CR10","unstructured":"Ministry of Health, Labour and Welfare (MHLW) (2017) Basic principles on the use of medical information databases in post-marketing pharmacovigilance. https:\/\/www.pmda.go.jp\/files\/000250561.pdf Accessed 23 Oct 2025"},{"key":"3011_CR11","unstructured":"Ministry of Health, Labour and Welfare (MHLW) (2025) References-2. Health and medical services: Cancer control; Overview of the \u201cCancer Control Act\u201d. https:\/\/www.mhlw.go.jp\/english\/wp\/wp-hw2\/part2\/p3_0026.pdf. Accessed 23 Oct 2025"},{"key":"3011_CR12","unstructured":"PRiME-R, Inc. (2025) Launch of J-CONNECT and the start of large-scale retrospective real-world data collection (CONNECT-2). [News release in Japanese]. https:\/\/prime-r.inc\/newsrelease\/674\/. Accessed 23 Oct 2025"},{"issue":"1","key":"3011_CR13","doi-asserted-by":"publisher","first-page":"2","DOI":"10.1093\/jjco\/hyt013","volume":"44","author":"T Higashi","year":"2014","unstructured":"Higashi T et al (2014) The national database of hospital-based cancer registries in Japan: a nationwide infrastructure to support evidence-based cancer care and cancer control policy in Japan. Jpn J Clin Oncol 44(1):2\u20138. https:\/\/doi.org\/10.1093\/jjco\/hyt013","journal-title":"Jpn J Clin Oncol"},{"key":"3011_CR14","doi-asserted-by":"publisher","first-page":"929","DOI":"10.1200\/CCI.20.00064","volume":"4","author":"D Potter","year":"2020","unstructured":"Potter D, Brothers R, Kolacevski A et al (2020) Development of CancerLinQ, a health information learning platform from multiple electronic health record systems to support improved quality of care. JCO Clin Cancer Inform 4:929\u2013937. https:\/\/doi.org\/10.1200\/CCI.20.00064","journal-title":"JCO Clin Cancer Inform"},{"key":"3011_CR15","doi-asserted-by":"publisher","first-page":"4460","DOI":"10.1111\/1475-6773.12872","volume":"53","author":"MD Curtis","year":"2018","unstructured":"Curtis MD, Griffith SD, Tucker M et al (2018) Development and validation of a high-quality composite real-world mortality endpoint. Health Serv Res 53:4460\u20134476. https:\/\/doi.org\/10.1111\/1475-6773.12872","journal-title":"Health Serv Res"},{"key":"3011_CR16","doi-asserted-by":"publisher","first-page":"818","DOI":"10.1158\/2159-8290.CD-17-0151","volume":"7","author":"AACR Project GENIE Consortium","year":"2017","unstructured":"AACR Project GENIE Consortium (2017) AACR Project GENIE: powering precision medicine through an international consortium. Cancer Discov 7:818\u2013831. https:\/\/doi.org\/10.1158\/2159-8290.CD-17-0151","journal-title":"Cancer Discov"}],"container-title":["International Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10147-026-03011-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10147-026-03011-4","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10147-026-03011-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T14:29:53Z","timestamp":1783780193000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10147-026-03011-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,24]]},"references-count":16,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,6]]}},"alternative-id":["3011"],"URL":"https:\/\/doi.org\/10.1007\/s10147-026-03011-4","relation":{},"ISSN":["1341-9625","1437-7772"],"issn-type":[{"value":"1341-9625","type":"print"},{"value":"1437-7772","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,24]]},"assertion":[{"value":"7 November 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 March 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 April 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 July 2026","order":5,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Update","order":6,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The Supplementary file was missing from this article and has now been uploaded.","order":7,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"MO, YM, and TK are employees of PRiME-R, which serves as the administrative office for the J-CONNECT registry under a contract with Kyoto University. DL is an employee of PPD Evidera. TKo is an employee of Clinical Study Support Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This analysis used only a secondary aggregated summary table of the J-CONNECT database. Therefore, no additional individual-level informed consent was obtained for conducting this analysis.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval\/Informed consent"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Clinical trial registration"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}}]}}