{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T15:02:34Z","timestamp":1789398154865,"version":"build-2803163510"},"reference-count":16,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T00:00:00Z","timestamp":1784764800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T00:00:00Z","timestamp":1784764800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"name":"JSPS KAKENHI","award":["JP23K11933"],"award-info":[{"award-number":["JP23K11933"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs - Real World Outcomes"],"published-print":{"date-parts":[[2026,9]]},"DOI":"10.1007\/s40801-026-00570-w","type":"journal-article","created":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T08:02:20Z","timestamp":1784793740000},"page":"421-429","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Feasibility of Reconstructing Survival Outcomes from Unstructured Electronic Medical Records under Japan\u2019s Next-Generation Medical Infrastructure Act: A Historical Cohort Study of Atezolizumab in Non-small Cell Lung Cancer"],"prefix":"10.1007","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6531-5220","authenticated-orcid":false,"given":"Masahiko","family":"Nakatsui","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosuke","family":"Nishida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suguru","family":"Nozue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukinori","family":"Sakata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mie","family":"Azuma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rika","family":"Abe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rika","family":"Okamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuki","family":"Nakagami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasushi","family":"Okuno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,7,23]]},"reference":[{"key":"570_CR1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2022.864960","volume":"9","author":"H Maeda","year":"2022","unstructured":"Maeda H, Ng DB. Regulatory approval with real-world data from regulatory science perspective in Japan. Front Med. 2022;9:864960. https:\/\/doi.org\/10.3389\/fmed.2022.864960.","journal-title":"Front Med"},{"key":"570_CR2","doi-asserted-by":"publisher","first-page":"1405","DOI":"10.1002\/cpt.70081","volume":"118","author":"H Okami","year":"2025","unstructured":"Okami H, Shimotsumagari Y, Maeda H. Evolving real-world data and evidence use for new drugs and regenerative medical products approvals in Japan\u2014An analysis of the 6-year trend. Clin Pharmacol Ther. 2025;118:1405. https:\/\/doi.org\/10.1002\/cpt.70081.","journal-title":"Clin Pharmacol Ther"},{"key":"570_CR3","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1002\/cpt.2410","volume":"111","author":"K Nishioka","year":"2022","unstructured":"Nishioka K, Makimura T, Ishiguro A. Evolving acceptance and use of RWE for regulatory decision making on the benefit\/risk assessment of a drug in Japan. Clin Pharmacol Ther. 2022;111:35\u201343. https:\/\/doi.org\/10.1002\/cpt.2410.","journal-title":"Clin Pharmacol Ther"},{"key":"570_CR4","doi-asserted-by":"publisher","first-page":"235","DOI":"10.1007\/s40801-023-00353-7","volume":"10","author":"R Wakabayashi","year":"2023","unstructured":"Wakabayashi R, Hirano T, Koga T, Kuwatsuru R. An attempt to replicate randomized trials of diabetes treatments using a Japanese administrative claims and health checkup database: a feasibility study. Drugs Real World Outcomes. 2023;10:235\u201347. https:\/\/doi.org\/10.1007\/s40801-023-00353-7.","journal-title":"Drugs Real World Outcomes"},{"key":"570_CR5","doi-asserted-by":"publisher","first-page":"910","DOI":"10.1002\/cpt.3540","volume":"117","author":"J Asano","year":"2025","unstructured":"Asano J, Sugano H, Murakami H, Noguchi A, Ando Y, Uyama Y. PMDA perspective on use of real-world data and real-world evidence as an external control: recent examples and considerations. Clin Pharmacol Ther. 2025;117:910\u20137. https:\/\/doi.org\/10.1002\/cpt.3540.","journal-title":"Clin Pharmacol Ther"},{"key":"570_CR6","unstructured":"Act on Anonymized Medical Data and Pseudonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field (Act No. 28 of 2017. Last version: Act No. 35 of 2023)."},{"key":"570_CR7","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-022-32310-3","volume":"13","author":"SV Wang","year":"2022","unstructured":"Wang SV, Sreedhara SK, Schneeweiss S. Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions. Nat Commun. 2022;13:5126. https:\/\/doi.org\/10.1038\/s41467-022-32310-3.","journal-title":"Nat Commun"},{"key":"570_CR8","unstructured":"U.S. Food and Drug Administration. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products. 2024. https:\/\/www.fda.gov\/media\/171667\/download. Accessed 6 Jan 2026."},{"key":"570_CR9","unstructured":"U.S. Food and Drug Administration. Considerations for the design and conduct of externally controlled trials for drug and biological products. https:\/\/www.fda.gov\/media\/164960\/download. Accessed 6 Jan 2026."},{"key":"570_CR10","unstructured":"European Medicines Agency. Real-world evidence provided by EMA. https:\/\/www.ema.europa.eu\/en\/documents\/other\/guide-real-world-evidence-provided-ema-support-regulatory-decision-making_en.pdf. Accessed 6 Jan 2026."},{"key":"570_CR11","unstructured":"European Medicines Agency. Draft concept paper on the development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making. EMA\/CHMP\/225255\/2025. 2025. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/draft-concept-paper-development-reflection-paper-use-external-controls-evidence-generation-regulatory-decision-making_en.pdf. Accessed 6 Jan 2026."},{"key":"570_CR12","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hyac098","author":"S Saji","year":"2022","unstructured":"Saji S, Ohsumi S, Ito M, Hayashi N, Kobayashi K, Masuda N, et\u00a0al. Subgroup analysis of Japanese patients in a phase III randomized, controlled study of neoadjuvant atezolizumab or placebo, combined with nab-paclitaxel and anthracycline-based chemotherapy in early triple-negative breast cancer (IMpassion031). Jpn J Clin Oncol. 2022. https:\/\/doi.org\/10.1093\/jjco\/hyac098.","journal-title":"Jpn J Clin Oncol"},{"key":"570_CR13","doi-asserted-by":"publisher","unstructured":"Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, Cortinovis DL, Leach J, Polikoff J, Barrios C, Kabbinavar F, Frontera OA, De Marinis F, Turna H, Lee JS, Ballinger M, Kowanetz M, He P, Chen DS, Sandler A, Gandara DR; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017;389(10066):255-265. https:\/\/doi.org\/10.1016\/S0140-6736(16)32517-X.","DOI":"10.1016\/S0140-6736(16)32517-X"},{"key":"570_CR14","unstructured":"Python 3.8.5 documentation. Python Software Foundation. https:\/\/docs.python.org\/3.8\/. Accessed 2025"},{"key":"570_CR15","unstructured":"lifelines 0.27.8 documentation. https:\/\/lifelines.readthedocs.io\/en\/v0.27.8\/. Accessed 2025"},{"key":"570_CR16","doi-asserted-by":"publisher","first-page":"e405","DOI":"10.1016\/j.cllc.2018.01.004","volume":"19","author":"T Hida","year":"2018","unstructured":"Hida T, Kaji R, Satouchi M, Ikeda N, Horiike A, Nokihara H, et\u00a0al. Atezolizumab in Japanese patients with previously treated advanced non-small-cell lung cancer: a subgroup analysis of the phase 3 OAK study. Clin Lung Cancer. 2018;19:e405\u201315. https:\/\/doi.org\/10.1016\/j.cllc.2018.01.004.","journal-title":"Clin Lung Cancer"}],"container-title":["Drugs - Real World Outcomes"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40801-026-00570-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40801-026-00570-w","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40801-026-00570-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T14:03:34Z","timestamp":1789394614000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40801-026-00570-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,23]]},"references-count":16,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["570"],"URL":"https:\/\/doi.org\/10.1007\/s40801-026-00570-w","relation":{},"ISSN":["2199-1154","2198-9788"],"issn-type":[{"value":"2199-1154","type":"print"},{"value":"2198-9788","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,23]]},"assertion":[{"value":"2 July 2026","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 July 2026","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Yosuke Nishida was an employee of NTT DATA Corporation at the time of the study. Suguru Nozue is an employee of NTT DATA Corporation. Yukinori Sakata and Mie Azuma are employees of Eisai Co., Ltd. The authors have no other relevant financial or non-financial interests to disclose.","order":1,"name":"Ethics","label":"Competing Interests","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The LDI data were collected by the opt-out consent process per the Next-Generation Medical Infrastructure Law, and the use of LDI data for this study was approved by the review board of LDI (application no.: 2023_MIL_0005).","order":2,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The LDI data were collected by the opt-out consent process per the Next-Generation Medical Infrastructure Law, and the use of LDI data for this study was approved by the review board of LDI (application no.: 2023_MIL_0005).","order":3,"name":"Ethics","label":"Consent to Publish","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Review Board of Life Data Initiative, a certified operator under the Act on Anonymized Medical Data and Pseudonymized Medical Data That Are Meant to Contribute to Research and Development in the Medical Field (Next-Generation Medical Infrastructure Act) (application no.: 2023_MIL_0005).","order":4,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}