{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T13:24:21Z","timestamp":1787059461379,"version":"build-2736575974"},"reference-count":49,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:00:00Z","timestamp":1787011200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:00:00Z","timestamp":1787011200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"DOI":"10.1007\/s43441-026-01034-7","type":"journal-article","created":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T12:27:54Z","timestamp":1787056074000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Patient-Reported Outcomes Used for Regulatory Approval of Medicines Indicated for the Treatment of Dermatological Diseases Authorized in the European Union Between 1998 and 2024"],"prefix":"10.1007","author":[{"given":"El\u00e9onore","family":"Coenen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diogo","family":"Almeida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2761-0955","authenticated-orcid":false,"given":"Bruno","family":"Sepodes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5542-9993","authenticated-orcid":false,"given":"Carla","family":"Torre","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,8,18]]},"reference":[{"key":"1034_CR1","unstructured":"European Medicines Agency. Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life (Hrql) Measures in the Evaluation of Medicinal Products. 2005. Available from: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/reflection-paper-regulatory-guidance-use-health-related-quality-life-hrql-measures-evaluation-medicinal-products_en.pdf. Accessed 15 Oct 2024."},{"key":"1034_CR2","doi-asserted-by":"publisher","first-page":"437","DOI":"10.1016\/j.jval.2011.11.032","volume":"15","author":"A Gnanasakthy","year":"2012","unstructured":"Gnanasakthy A, Mordin M, Clark M, DeMuro C, Fehnel S, Copley-Merriman C. A Review of Patient-Reported Outcome Labels in the United States: 2006 to 2010. Value Health. 2012;15:437\u201342. https:\/\/doi.org\/10.1016\/j.jval.2011.11.032.","journal-title":"Value Health"},{"key":"1034_CR3","unstructured":"European Medicines Agency. EMA Regulatory Science to 2025. 2025. Available from: https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/ema-regulatory-science-2025-strategic-reflection_en.pdf. Accessed 15 Oct 2024."},{"key":"1034_CR4","unstructured":"European Medicines Agency. Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man. 2016. Available from: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-clinical-evaluation-anticancer-medicinal-products-revision-6_en.pdf. Accessed 15 Oct 2024."},{"key":"1034_CR5","doi-asserted-by":"publisher","first-page":"57","DOI":"10.1186\/s41687-022-00466-7","volume":"6","author":"K Maruszczyk","year":"2022","unstructured":"Maruszczyk K, Aiyegbusi OL, Torlinska B, Collis P, Keeley T, Calvert MJ. Systematic review of guidance for the collection and use of patient-reported outcomes in real-world evidence generation to support regulation, reimbursement and health policy. J Patient Rep Outcomes. 2022;6:57. https:\/\/doi.org\/10.1186\/s41687-022-00466-7.","journal-title":"J Patient Rep Outcomes"},{"key":"1034_CR6","doi-asserted-by":"publisher","first-page":"650","DOI":"10.1038\/s41591-024-02827-9","volume":"30","author":"OL Aiyegbusi","year":"2024","unstructured":"Aiyegbusi OL, Cruz Rivera S, Roydhouse J, Kamudoni P, Alder Y, Anderson N, et al. Recommendations to address respondent burden associated with patient-reported outcome assessment. Nat Med. 2024;30:650\u20139. https:\/\/doi.org\/10.1038\/s41591-024-02827-9.","journal-title":"Nat Med"},{"key":"1034_CR7","unstructured":"Julian Higgins JTJCMCTLMPVW. accessed March 16,. Cochrane Handbook for Systematic Reviews of Interventions. Version 65 2024. https:\/\/training.cochrane.org\/handbook\/current (2025)."},{"key":"1034_CR8","doi-asserted-by":"publisher","first-page":"e0267030","DOI":"10.1371\/journal.pone.0267030","volume":"17","author":"L Carfora","year":"2022","unstructured":"Carfora L, Foley CM, Hagi-Diakou P, Lesty PJ, Sandstrom ML, Ramsey I, et al. Patients\u2019 experiences and perspectives of patient-reported outcome measures in clinical care: A systematic review and qualitative meta-synthesis. PLoS ONE. 2022;17:e0267030. https:\/\/doi.org\/10.1371\/journal.pone.0267030.","journal-title":"PLoS ONE"},{"key":"1034_CR9","doi-asserted-by":"publisher","unstructured":"Almeida D, Umuhire D, Gonzalez-Quevedo R, Ant\u00f3nio A, Burgos JG, Verpillat P, et al. Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU. Front Med (Lausanne). 2024;11. https:\/\/doi.org\/10.3389\/fmed.2024.1408636.","DOI":"10.3389\/fmed.2024.1408636"},{"key":"1034_CR10","doi-asserted-by":"publisher","unstructured":"Weldring T, Smith SMS. Article Commentary: Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights. 2013;6. https:\/\/doi.org\/10.4137\/HSI.S11093.","DOI":"10.4137\/HSI.S11093"},{"key":"1034_CR11","doi-asserted-by":"publisher","unstructured":"Snyder DJ, Zilinyi RS, Cohen DJ, Parikh SA, Sethi SS. Patient-Reported Outcomes in Venous Thromboembolism: A Systematic Review of the Literature, Current Challenges, and Ways Forward. J Am Heart Assoc. 2023;12. https:\/\/doi.org\/10.1161\/JAHA.123.032146.","DOI":"10.1161\/JAHA.123.032146"},{"key":"1034_CR12","doi-asserted-by":"publisher","first-page":"100145","DOI":"10.1016\/j.metip.2024.100145","volume":"10","author":"M Philip","year":"2024","unstructured":"Philip M. Questionnaire, rating scale and checklist \u2013 How do they differ? Methods Psychol. 2024;10:100145. https:\/\/doi.org\/10.1016\/j.metip.2024.100145.","journal-title":"Methods Psychol"},{"key":"1034_CR13","doi-asserted-by":"publisher","first-page":"203","DOI":"10.1007\/s40271-016-0196-6","volume":"10","author":"C Copley-Merriman","year":"2017","unstructured":"Copley-Merriman C, Zelt S, Clark M, Gnanasakthy A. Impact of Measuring Patient-Reported Outcomes in Dermatology Drug Development. Patient. 2017;10:203\u201313. https:\/\/doi.org\/10.1007\/s40271-016-0196-6.","journal-title":"Patient"},{"key":"1034_CR14","unstructured":"World Health Organization. Skin Diseases as a Global Public Health Priority 2024. Available from: https:\/\/knowledge-action-portal.com\/en\/news_and_events\/news\/9253. Accessed 5 Nov 5 2024."},{"key":"1034_CR15","doi-asserted-by":"publisher","first-page":"1499","DOI":"10.1038\/jid.2013.513","volume":"134","author":"LM Hollestein","year":"2014","unstructured":"Hollestein LM, Nijsten T. An Insight into the Global Burden of Skin Diseases. J Invest Dermatology. 2014;134:1499\u2013501. https:\/\/doi.org\/10.1038\/jid.2013.513.","journal-title":"J Invest Dermatology"},{"key":"1034_CR16","doi-asserted-by":"publisher","first-page":"956","DOI":"10.5114\/ada.2019.86182","volume":"37","author":"B Kowalewska","year":"2020","unstructured":"Kowalewska B, Jankowiak B, Krajewska-Ku\u0142ak E, Khvorik DF, Niczyporuk W. Quality of life in skin diseases as perceived by patients and nurses. Adv Dermatol Allergol. 2020;37:956\u201361. https:\/\/doi.org\/10.5114\/ada.2019.86182.","journal-title":"Adv Dermatol Allergol"},{"key":"1034_CR17","doi-asserted-by":"publisher","first-page":"499","DOI":"10.1007\/s40257-023-00758-8","volume":"24","author":"AM Snyder","year":"2023","unstructured":"Snyder AM, Chen SC, Chren M-M, Ferris LK, Edwards LD, Swerlick RA, et al. Patient-Reported Outcome Measures and Their Clinical Applications in Dermatology. Am J Clin Dermatol. 2023;24:499\u2013511. https:\/\/doi.org\/10.1007\/s40257-023-00758-8.","journal-title":"Am J Clin Dermatol"},{"key":"1034_CR18","doi-asserted-by":"publisher","first-page":"445","DOI":"10.1007\/s40271-019-00373-y","volume":"12","author":"A Barrett","year":"2019","unstructured":"Barrett A, Hahn-Pedersen J, Kragh N, Evans E, Gnanasakthy A. Patient-Reported Outcome Measures in Atopic Dermatitis and Chronic Hand Eczema in Adults. Patient. 2019;12:445\u201359. https:\/\/doi.org\/10.1007\/s40271-019-00373-y.","journal-title":"Patient"},{"key":"1034_CR19","unstructured":"European Medicines Agency. Download medicine data. 2025. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/download-medicine-data. Accessed 3 Jan 3 2025."},{"key":"1034_CR20","unstructured":"European Medicines Agency. European Medicines Agency Website. n.d. Accessed from: https:\/\/www.ema.europa.eu\/en\/homepage. Accessed 14 Oct 2024."},{"key":"1034_CR21","unstructured":"European Medicines Agency. European public assessment report: background and context. n.d. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/what-we-publish-medicines-and-when\/european-public-assessment-reports-background-and-context. Accessed 28 Oct 2024."},{"key":"1034_CR22","unstructured":"European Medicines Agency. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure. n.d. Available from: https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf. Accessed 28 Oct 2024."},{"key":"1034_CR23","unstructured":"European Medicines Agency. Summary of product characteristics n.d. https:\/\/www.ema.europa.eu\/en\/glossary-terms\/summary-product-characteristics Accessed 28 October 2024."},{"key":"1034_CR24","doi-asserted-by":"publisher","unstructured":"Naeem M, Ozuem W, Howell K, Ranfagni S. A Step-by-Step Process of Thematic Analysis to Develop a Conceptual Model in Qualitative Research. Int J Qual Methods. 2023;22. https:\/\/doi.org\/10.1177\/16094069231205789.","DOI":"10.1177\/16094069231205789"},{"key":"1034_CR25","doi-asserted-by":"publisher","first-page":"925","DOI":"10.1007\/s40258-023-00827-3","volume":"21","author":"M Meregaglia","year":"2023","unstructured":"Meregaglia M, Malandrini F, Angelini S, Ciani O. The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022. Appl Health Econ Health Policy. 2023;21:925\u201335. https:\/\/doi.org\/10.1007\/s40258-023-00827-3.","journal-title":"Appl Health Econ Health Policy"},{"key":"1034_CR26","doi-asserted-by":"publisher","first-page":"adv00559","DOI":"10.2340\/00015555-3884","volume":"101","author":"R Pattinson","year":"2021","unstructured":"Pattinson R, Trialonis-Suthakharan N, Gupta S, Henry A, Lavall\u00e9e J, Otten M, et al. Patient-Reported Outcome Measures in Dermatology: A Systematic Review. Acta Derm Venereol. 2021;101:adv00559. https:\/\/doi.org\/10.2340\/00015555-3884.","journal-title":"Acta Derm Venereol"},{"key":"1034_CR27","doi-asserted-by":"publisher","unstructured":"Sauchelli S, Levy C, Gnanasakthy A, Dave V, Doward L, Fitzgerald KA, et al. From clinical trials to informing clinical decision-making: a review of patient-reported outcomes in nononcology medicines approved by the European Medicines Agency (2018\u20132022). Front Pharmacol. 2025;16. https:\/\/doi.org\/10.3389\/fphar.2025.1536401.","DOI":"10.3389\/fphar.2025.1536401"},{"key":"1034_CR28","doi-asserted-by":"publisher","DOI":"10.1007\/s43441-023-00573-7","author":"N Bertelsen","year":"2023","unstructured":"Bertelsen N, Dewulf L, Ferr\u00e8 S, Vermeulen R, Schroeder K, Gatellier L, et al. Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review. Ther Innov Regul Sci. 2023. https:\/\/doi.org\/10.1007\/s43441-023-00573-7.","journal-title":"Ther Innov Regul Sci"},{"key":"1034_CR29","unstructured":"Heads of Medicines Agency (HMA), European Medicines Agency (EMA). European Medicines Agencies Network Strategy 2028. 2025. Available from: https:\/\/www.ema.europa.eu\/en\/documents\/other\/seizing-opportunities-changing-medicines-landscape-european-medicines-agencies-network-strategy-2028-final_en.pdf. Accessed 17 Jul 2025."},{"key":"1034_CR30","unstructured":"European Medicines Agency (EMA). Patient experience data in EU medicines development and regulatory decision-making: Outcome of the workshop on 21st September 2022. 2022. Available from: https:\/\/www.ema.europa.eu\/en\/documents\/other\/executive-summary-patient-experience-data-eu-medicines-development-and-regulatory-decision-making-workshop_en.pdf. Accessed 17 Jul 2025."},{"key":"1034_CR31","doi-asserted-by":"publisher","first-page":"5296","DOI":"10.3390\/ijerph20075296","volume":"20","author":"J Barman-Aks\u00f6zen","year":"2023","unstructured":"Barman-Aks\u00f6zen J, Minder A-E, Granata F, Pettersson M, Dechant C, Aks\u00f6zen MH, et al. Quality-Adjusted Life Years in Erythropoietic Protoporphyria and Other Rare Diseases: A Patient-Initiated EQ-5D Feasibility Study. Int J Environ Res Public Health. 2023;20:5296. https:\/\/doi.org\/10.3390\/ijerph20075296.","journal-title":"Int J Environ Res Public Health"},{"key":"1034_CR32","doi-asserted-by":"publisher","first-page":"2933","DOI":"10.1007\/s10072-023-06825-6","volume":"44","author":"O Ciani","year":"2023","unstructured":"Ciani O, Meregaglia M, Battaglia MA, Brichetto G, Conte A, Gasperini C, et al. Patient-reported outcome measures in drugs for neurological conditions approved by European Medicines Agency 2017\u20132022. Neurol Sci. 2023;44:2933\u20137. https:\/\/doi.org\/10.1007\/s10072-023-06825-6.","journal-title":"Neurol Sci"},{"key":"1034_CR33","doi-asserted-by":"publisher","first-page":"77","DOI":"10.1002\/cpt.2480","volume":"111","author":"S Dagenais","year":"2022","unstructured":"Dagenais S, Russo L, Madsen A, Webster J, Becnel L. Use of Real-World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design. Clin Pharmacol Ther. 2022;111:77\u201389. https:\/\/doi.org\/10.1002\/cpt.2480.","journal-title":"Clin Pharmacol Ther"},{"key":"1034_CR34","doi-asserted-by":"publisher","first-page":"e051673","DOI":"10.1136\/bmjopen-2021-051673","volume":"11","author":"Y Qian","year":"2021","unstructured":"Qian Y, Walters SJ, Jacques R, Flight L. Comprehensive review of statistical methods for analysing patient-reported outcomes (PROs) used as primary outcomes in randomised controlled trials (RCTs) published by the UK\u2019s Health Technology Assessment (HTA) journal (1997\u20132020). BMJ Open. 2021;11:e051673. https:\/\/doi.org\/10.1136\/bmjopen-2021-051673.","journal-title":"BMJ Open"},{"key":"1034_CR35","doi-asserted-by":"publisher","first-page":"1419","DOI":"10.1001\/jamadermatol.2022.3911","volume":"158","author":"S Ly","year":"2022","unstructured":"Ly S, Miller J, Tong L, Blake L, Mostaghimi A, Barbieri JS. Use of Patient-Reported Outcomes in Acne Vulgaris and Rosacea Clinical Trials From 2011 to 2021. JAMA Dermatol. 2022;158:1419. https:\/\/doi.org\/10.1001\/jamadermatol.2022.3911.","journal-title":"JAMA Dermatol"},{"key":"1034_CR36","doi-asserted-by":"publisher","first-page":"353","DOI":"10.2147\/PROM.S156279","volume":"9","author":"R Mercieca-Bebber","year":"2018","unstructured":"Mercieca-Bebber R, King MT, Calvert MJ, Stockler MR, Friedlander M. The importance of patient-reported outcomes in clinical trials and strategies for future optimization. Patient Relat Outcome Meas. 2018;9:353\u201367. https:\/\/doi.org\/10.2147\/PROM.S156279.","journal-title":"Patient Relat Outcome Meas"},{"key":"1034_CR37","doi-asserted-by":"publisher","first-page":"333","DOI":"10.1016\/j.det.2022.03.002","volume":"40","author":"SR Daniels","year":"2022","unstructured":"Daniels SR, Marcus KA, Bent R, Papadopoulos E. Measuring What Matters to Patients in Dermatology Drug Development. Dermatol Clin. 2022;40:333\u20137. https:\/\/doi.org\/10.1016\/j.det.2022.03.002.","journal-title":"Dermatol Clin"},{"key":"1034_CR38","unstructured":"European Medicines Agency. Scientific advice and protocol assistance. n.d. Available from: https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/scientific-advice-protocol-assistance. Accessed 16 Mar 2025."},{"key":"1034_CR39","doi-asserted-by":"publisher","unstructured":"Thomas KS, Apfelbacher CA, Chalmers JR, Simpson E, Spuls PI, Gerbens LAA et al. Recommended core outcome instruments for health-related quality of life, long\u2010term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting. Br J Dermatol 2020:bjd19673. https:\/\/doi.org\/10.1111\/bjd.19673","DOI":"10.1111\/bjd.19673"},{"key":"1034_CR40","doi-asserted-by":"publisher","first-page":"1429","DOI":"10.1001\/jamadermatol.2022.4211","volume":"158","author":"YA Leshem","year":"2022","unstructured":"Leshem YA, Chalmers JR, Apfelbacher C, Katoh N, Gerbens LAA, Schmitt J, et al. Measuring Atopic Eczema Control and Itch Intensity in Clinical Practice. JAMA Dermatol. 2022;158:1429. https:\/\/doi.org\/10.1001\/jamadermatol.2022.4211.","journal-title":"JAMA Dermatol"},{"key":"1034_CR41","doi-asserted-by":"publisher","first-page":"315","DOI":"10.1093\/bjd\/ljad079","volume":"190","author":"J Vyas","year":"2024","unstructured":"Vyas J, Johns JR, Ali FM, Singh RK, Ingram JR, Salek S, et al. A systematic review of 454 randomized controlled trials using the Dermatology Life Quality Index: experience in 69 diseases and 43 countries. Br J Dermatol. 2024;190:315\u201339. https:\/\/doi.org\/10.1093\/bjd\/ljad079.","journal-title":"Br J Dermatol"},{"key":"1034_CR42","doi-asserted-by":"publisher","unstructured":"Aiyegbusi OL, Roydhouse J, Rivera SC, Kamudoni P, Schache P, Wilson R, et al. Key considerations to reduce or address respondent burden in patient-reported outcome (PRO) data collection. Nat Commun. 2022;13. https:\/\/doi.org\/10.1038\/S41467-022-33826-4.","DOI":"10.1038\/S41467-022-33826-4"},{"key":"1034_CR43","doi-asserted-by":"publisher","first-page":"167","DOI":"10.1159\/000496923","volume":"235","author":"PV Chernyshov","year":"2019","unstructured":"Chernyshov PV. The Evolution of Quality of Life Assessment and Use in Dermatology. Dermatology. 2019;235:167\u201374. https:\/\/doi.org\/10.1159\/000496923.","journal-title":"Dermatology"},{"key":"1034_CR44","unstructured":"European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) Assessment report Filsuvez. 2022. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/filsuvez. Accessed 8 Feb 2025."},{"key":"1034_CR45","unstructured":"European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) Assessment report Filsuvez variation. 2024. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/filsuvez. Accessed 8 Feb 2025."},{"key":"1034_CR46","unstructured":"European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) Assessment report Scenesse. 2014. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/scenesse. Accessed 8 Feb 2025."},{"key":"1034_CR47","doi-asserted-by":"publisher","first-page":"925","DOI":"10.1016\/j.jval.2019.03.010","volume":"22","author":"YD Hong","year":"2019","unstructured":"Hong YD, Villalonga-Olives E, Perfetto EM. Patient-Reported Outcomes in Orphan Drug Labels Approved by the US Food and Drug Administration. Value Health. 2019;22:925\u201330. https:\/\/doi.org\/10.1016\/j.jval.2019.03.010.","journal-title":"Value Health"},{"key":"1034_CR48","unstructured":"European Medicines Agency. Guideline on Missing Data in Confirmatory Clinical Trials. 2010. Available from: https:\/\/www.ema.europa.eu\/en\/missing-data-confirmatory-clinical-trials-scientific-guideline. Accessed 18 Feb 2025."},{"key":"1034_CR49","doi-asserted-by":"publisher","unstructured":"Teixeira MM, Borges FC, Ferreira PS, Rocha J, Sepodes B, Torre C. A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020. Front Med (Lausanne). 2022;9. https:\/\/doi.org\/10.3389\/fmed.2022.968272.","DOI":"10.3389\/fmed.2022.968272"}],"container-title":["Therapeutic Innovation & Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-026-01034-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s43441-026-01034-7","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-026-01034-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T12:27:59Z","timestamp":1787056079000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s43441-026-01034-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,18]]},"references-count":49,"alternative-id":["1034"],"URL":"https:\/\/doi.org\/10.1007\/s43441-026-01034-7","relation":{},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"value":"2168-4790","type":"print"},{"value":"2168-4804","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,18]]},"assertion":[{"value":"28 July 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 August 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 August 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency\/agencies or organizations with which the author(s) is\/are employed\/affiliated.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}}]}}