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We aimed to review key hurdles for pediatric trials and recommend practical solutions. This position paper was developed jointly by the European and North American Societies for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN and NASPGHAN), in consultation with patient representatives. A systematic review was performed for identified topics, and two voting rounds with two group meetings led to agreement on 24 statements. The systematic review (reviewing 4366 manuscripts, of which 123 were included in tables of evidence and 213 in support of 23 statements) found similar biologic pathogenesis, and similar or better effectiveness and safety in children older than 2 years compared to adults. Pharmacokinetics were similar in adolescents but dissimilar in younger children. The review also found sufficiently accurate noninvasive endpoints to reflect post\u2010induction treatment response. There was no significant added benefit for ileocolonoscopy over sigmoidoscopy in ulcerative colitis. Drugs should be approved in children &gt;12 years and \u226540\u2009kg based on extrapolation from adult and real\u2010world data. While efficacy may be extrapolated to children &lt;40\u2009kg, pharmacokinetics cannot and thus one open\u2010label single\u2010arm study should be performed to establish a dose that matches adult exposure\u2010response from the adult trial in which adolescents may be enrolled if not exposed to placebo. Full colonoscopies should be minimized in the pediatric dosing trial. Efficacy in patients with infantile IBD cannot be extrapolated from adult data.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jpn3.70275","type":"journal-article","created":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T07:00:23Z","timestamp":1767250823000},"page":"867-894","source":"Crossref","is-referenced-by-count":10,"title":["Reshaping study design for faster extrapolation\u2010based drug approval in pediatric inflammatory bowel diseases: An ESPGHAN\u2013NASPGHAN position paper"],"prefix":"10.1002","volume":"82","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5160-868X","authenticated-orcid":false,"given":"Dan","family":"Turner","sequence":"first","affiliation":[{"name":"The Juliet Keidan Institute of Pediatric Gastroenterology, the Eisenberg R&amp;D Authority, Shaare Zedek Medical Center The Hebrew University of Jerusalem Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amit","family":"Assa","sequence":"additional","affiliation":[{"name":"The Juliet Keidan Institute of Pediatric Gastroenterology, the Eisenberg R&amp;D Authority, Shaare Zedek Medical Center The Hebrew University of Jerusalem Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikkel","family":"Malham","sequence":"additional","affiliation":[{"name":"Child Life and Health, Centre for Inflammation Research, University of Edinburgh AND Department of Paediatric Gastroenterology and Hepatology Royal Hospital for Children and Young People Edinburgh UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shira Yuval","family":"Bar\u2010Asher","sequence":"additional","affiliation":[{"name":"The Juliet Keidan Institute of Pediatric Gastroenterology, the Eisenberg R&amp;D Authority, Shaare Zedek Medical Center The Hebrew University of Jerusalem Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carla","family":"Rayan","sequence":"additional","affiliation":[{"name":"Inflammatory Bowel Disease Center, SickKids Hospital University of Toronto Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey S.","family":"Hyams","sequence":"additional","affiliation":[{"name":"Connecticut Children's Medical Center University of Connecticut School of Medicine Hartford Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holm H.","family":"Uhlig","sequence":"additional","affiliation":[{"name":"Centre for Human Genetics &amp; 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