{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,4]],"date-time":"2026-07-04T15:18:55Z","timestamp":1783178335505,"version":"3.54.6"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T00:00:00Z","timestamp":1782086400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T00:00:00Z","timestamp":1782086400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"name":"Fundaci\u00f3 Instituci\u00f3 dels Centres de Recerca de Catalunya"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pharm Med"],"published-print":{"date-parts":[[2026,7]]},"DOI":"10.1007\/s40290-026-00613-1","type":"journal-article","created":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T12:36:58Z","timestamp":1782131818000},"page":"311-324","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Language as an Eligibility Criterion in Pediatric Study Protocols Conducted in Europe (2007\u20132024) Reported in the ClinicalTrials.gov Database"],"prefix":"10.1007","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4494-3663","authenticated-orcid":false,"given":"Begonya","family":"Nafria","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Perera","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Segolene","family":"Gaillard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martine","family":"Dehlinger-Kremer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Dicks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricardo M.","family":"Fernandes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilles","family":"Vassal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pirkko","family":"Lepola","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gunter F.","family":"Egger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy","family":"Bray","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara E.","family":"Bierer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bob","family":"Phillips","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,6,22]]},"reference":[{"key":"613_CR1","unstructured":"Regulation (EC) No 1901\/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768\/92, Directive 2001\/20\/EC, Directive 2001\/83\/EC and Regulation (EC) No\u00a0726\/2004. Available from: https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX:32006R1901. [Accessed 17 Oct 2025]."},{"key":"613_CR2","unstructured":"Regulation (EU) No\u00a0536\/2014 of the European Parliament and of the Council of 16\u00a0April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001\/20\/EC. Available from: https:\/\/eur-lex.europa.eu\/eli\/reg\/2014\/536\/oj. [Accessed 17 Oct 2025]."},{"key":"613_CR3","unstructured":"Charter of Fundamental Rights of the European Union (18.12.2000) Official Journal of the European Communities. C364\/9 https:\/\/www.europarl.europa.eu\/charter\/pdf\/text_en.pdf. [Accessed 17 Oct 2025]."},{"key":"613_CR4","unstructured":"Convention on the Rights of the Child, Nov. 20, 1989. https:\/\/www.unicef.org.uk\/wp-content\/uploads\/2016\/08\/unicef-convention-rights-child-uncrc.pdf [Accessed 17 Oct 2025]."},{"key":"613_CR5","unstructured":"ICH E17- General Principles for Planning and Design of Multi-Regional Clinical Trials. Link: https:\/\/database.ich.org\/sites\/default\/files\/E17EWG_Step4_2017_1116.pdfAccessed 17 Oct 2025."},{"key":"613_CR6","doi-asserted-by":"publisher","unstructured":"Othman AM, Thompson LA. What parents should know about children with multiple languages. JAMA Pediatr. 2024. https:\/\/doi.org\/10.1001\/jamapediatrics.2024.4495 Accessed on the 17th of October, 2025.","DOI":"10.1001\/jamapediatrics.2024.4495"},{"issue":"9","key":"613_CR7","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1003758","volume":"18","author":"AV Muthukumar","year":"2021","unstructured":"Muthukumar AV, Morrell W, Bierer BE. Evaluating the frequency of English language requirements in clinical trial eligibility criteria: a systematic analysis using ClinicalTrials. gov. PLoS Med. 2021;18(9):e1003758. https:\/\/doi.org\/10.1371\/journal.pmed.1003758.","journal-title":"PLoS Med"},{"key":"613_CR8","unstructured":"Department of Health, Education, and Welfare; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. J Am Coll Dent. 2014; ;81(3):4\u201313."},{"key":"613_CR9","unstructured":"The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Washington, DC; 1979. Available from: https:\/\/www.hhs.gov\/ohrp\/sites\/default\/files\/the-belmont-report-508c_FINAL.pdf. [Accessed 17 Oct 2025]."},{"key":"613_CR10","unstructured":"Guidance for best practices for clinical trials. World Health Organization, Geneva; 2024. Licence: CC\u00a0BY-NC-SA\u00a03.0\u00a0IGO. Available from: https:\/\/iris.who.int\/bitstream\/handle\/10665\/378782\/9789240097711-eng.pdf. [Accessed 17 Oct 2025]."},{"key":"613_CR11","unstructured":"EMA. EnprEma. Available from: http:\/\/enprema.ema.europa.eu\/enprema. [Accessed 17 Oct 2025]."},{"issue":"3","key":"613_CR12","doi-asserted-by":"publisher","first-page":"839","DOI":"10.1038\/s41390-025-03845-0","volume":"98","author":"AV Muthukumar","year":"2025","unstructured":"Muthukumar AV, Shah KM, Glynn RJ, Bierer BE. Persistent exclusion of non-English speakers in pediatric research: a national analysis using ClinicalTrials.gov. Pediatr Res. 2025;98(3):839\u201343. https:\/\/doi.org\/10.1038\/s41390-025-03845-0.","journal-title":"Pediatr Res"},{"issue":"1","key":"613_CR13","doi-asserted-by":"publisher","first-page":"81","DOI":"10.1001\/jamapediatrics.2022.3828","volume":"177","author":"A Chen","year":"2023","unstructured":"Chen A, Demaestri S, Schweiberger K, et al. Inclusion of non-English-speaking participants in pediatric health research: a review. JAMA Pediatr. 2023;177(1):81\u20138. https:\/\/doi.org\/10.1001\/jamapediatrics.2022.3828.","journal-title":"JAMA Pediatr"},{"issue":"9","key":"613_CR14","doi-asserted-by":"publisher","DOI":"10.1002\/nop2.70048","volume":"11","author":"LN Bulto","year":"2024","unstructured":"Bulto LN. Voices unheard: bridging language gaps, ensuring equity and inclusion of non-native speakers in health research and clinical trials. Nurs Open. 2024;11(9):e70048. https:\/\/doi.org\/10.1002\/nop2.70048.","journal-title":"Nurs Open"},{"issue":"2","key":"613_CR15","doi-asserted-by":"publisher","first-page":"214","DOI":"10.1001\/jamapediatrics.2024.5619","volume":"179","author":"R Brown","year":"2025","unstructured":"Brown R, Ortiz P, Berrigan L, Cullen D. Multilingual research strategies to enhance equity. JAMA Pediatr. 2025;179(2):214\u20135. https:\/\/doi.org\/10.1001\/jamapediatrics.2024.5619.","journal-title":"JAMA Pediatr"},{"key":"613_CR16","doi-asserted-by":"publisher","DOI":"10.1002\/pbc.31521","volume":"72","author":"J Ruiz","year":"2025","unstructured":"Ruiz J, Robles JM, S\u00e1nchez LM, Khan A, Lu AD, Marjerrison S, et al. Achieving language justice in pediatric hematology-oncology: a multinational perspective for language-concordant equitable patient- and family-centered care and research inclusion. Pediatr Blood Cancer. 2025;72:e31521. https:\/\/doi.org\/10.1002\/pbc.31521.","journal-title":"Pediatr Blood Cancer"},{"key":"613_CR17","doi-asserted-by":"publisher","first-page":"100188","DOI":"10.1016\/j.ejcped.2024.100188","volume":"4","author":"A-D Sierra","year":"2024","unstructured":"Sierra A-D, Solenne C, Nanna MH, Sylvain B, Hanne BL, Britt PT, et al. Cross-border access to early phase clinical trials for children with cancer in the Nordic region. EJC Paediatric Oncol. 2024;4:100188. https:\/\/doi.org\/10.1016\/j.ejcped.2024.100188.","journal-title":"EJC Paediatric Oncol"},{"key":"613_CR18","doi-asserted-by":"publisher","first-page":"74","DOI":"10.1016\/j.cct.2018.01.003","volume":"66","author":"GD Huang","year":"2018","unstructured":"Huang GD, Bull J, Johnston McKee K, Mahon E, Harper B, Roberts JN. Clinical trials recruitment planning: a proposed framework from the Clinical Trials Transformation Initiative. Contemp Clin Trials. 2018;66:74\u20139. https:\/\/doi.org\/10.1016\/j.cct.2018.01.003.","journal-title":"Contemp Clin Trials"}],"container-title":["Pharmaceutical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40290-026-00613-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40290-026-00613-1","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40290-026-00613-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,4]],"date-time":"2026-07-04T15:04:39Z","timestamp":1783177479000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40290-026-00613-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,22]]},"references-count":18,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["613"],"URL":"https:\/\/doi.org\/10.1007\/s40290-026-00613-1","relation":{},"ISSN":["1178-2595","1179-1993"],"issn-type":[{"value":"1178-2595","type":"print"},{"value":"1179-1993","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,22]]},"assertion":[{"value":"28 April 2026","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 June 2026","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Begonya Nafria, Alexander Perera, Segolene Gaillard, Martine Dehlinger-Kremer, Pamela Dicks, Ricardo M. Fernandes, Gilles Vassal, Pirkko Lepola, Gunter F. Egger, Lucy Bray, Barbara E. Bierer, and Bob Phillips have no conflicts of interest that are directly relevant to the content of this article.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}},{"value":"The project was approved by the Ethics Committee of the Institut de Recerca Sant Joan de D\u00e9u on 9 March, 2023 (code PIC-40-23).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"The datasets generated and\/or analyzed during the current study are available from the corresponding author on reasonable request.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Data and Material"}},{"value":"The computer program is not available.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}},{"value":"Conception and design of the paper: BN; data collection: BN and AP; data curation: BN and AP; formal analysis: BN; investigation: BN; methodology: BN; writing (original draft): BN; writing (review and editing): all authors. All authors read and approved the final version of the manuscript.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}},{"value":"The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties or reflecting the position of the regulatory agency\/agencies or organizations with which the authors are affiliated.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 Disclaimer"}}]}}