{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,3]],"date-time":"2025-08-03T04:30:47Z","timestamp":1754195447338,"version":"3.40.5"},"reference-count":32,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,11,5]],"date-time":"2022-11-05T00:00:00Z","timestamp":1667606400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100010767","name":"Innovative Medicines Initiative","doi-asserted-by":"publisher","award":["777389"],"award-info":[{"award-number":["777389"]}],"id":[{"id":"10.13039\/501100010767","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Health Planning &amp; Management"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The conect4children (c4c) consortium was setup to facilitate the development of new drugs and therapies for paediatric populations and address key challenges associated with paediatric clinical trials. Two of the major adopting principles for c4c were academia\u2010industry partnership and data harmonisation and interoperability through common eCRF definitions. To understand the challenges arising out of these principles, the c4c team at Newcastle University conducted semi\u2010structured interviews with four c4c industry partners.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Each partner was asked 10 questions about the data standards used in their company, management and maintenance of data dictionaries, how they dealt with paediatric\u2010specific issues, major knowledge gaps and how academia could aid in bridging these gaps. Thematic analysis was performed to identify patterns in their answers.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>All companies use the Clinical Data Interchange Standards Consortium (CDISC) standards but face problems when certain terminology is not included in CDISC (e.g., paediatric\u2010specific terminologies). All companies were committed to interoperability and had strict policies about how additional terminology could be added to their dictionaries. Three of the four companies maintained a single dictionary but also had lighter versions for specific usage. The two major knowledge gaps identified from the interviews were handling of non\u2010CDISC terminology and maintenance of normal lab ranges in dictionaries.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>To address these gaps, c4c has been working on a four\u2010point plan including the development of a cross\u2010cutting paediatric dictionary and a paediatric user guide in collaboration with CDISC.<\/jats:p><\/jats:sec>","DOI":"10.1002\/hpm.3592","type":"journal-article","created":{"date-parts":[[2022,11,6]],"date-time":"2022-11-06T03:38:00Z","timestamp":1667705880000},"page":"416-429","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Understanding paediatric data standards challenges through academia\u2010industry partnerships: A conect4children (c4c) qualitative study"],"prefix":"10.1002","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6761-2632","authenticated-orcid":false,"given":"Anando","family":"Sen","sequence":"first","affiliation":[{"name":"John Walton Muscular Dystrophy Research Centre Faculty of Medical Sciences Newcastle University  Newcastle upon Tyne UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6171-5793","authenticated-orcid":false,"given":"Avril","family":"Palmeri","sequence":"additional","affiliation":[{"name":"John Walton Muscular Dystrophy Research Centre Faculty of Medical Sciences Newcastle University  Newcastle upon Tyne UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5359-2941","authenticated-orcid":false,"given":"Joanne","family":"Lee","sequence":"additional","affiliation":[{"name":"John Walton Muscular Dystrophy Research Centre Faculty of Medical Sciences Newcastle University  Newcastle upon Tyne UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4437-2469","authenticated-orcid":false,"given":"Victoria","family":"Hedley","sequence":"additional","affiliation":[{"name":"John Walton Muscular Dystrophy Research Centre Faculty of Medical Sciences Newcastle University  Newcastle upon Tyne UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacques","family":"Thuet","sequence":"additional","affiliation":[{"name":"Institut de Recherches Internationales Servier  Suresnes France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Perrine","family":"Lignon","sequence":"additional","affiliation":[{"name":"Institut de Recherches Internationales Servier  Suresnes France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valerie","family":"Cotonnec","sequence":"additional","affiliation":[{"name":"Institut de Recherches Internationales Servier  Suresnes France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8039-5334","authenticated-orcid":false,"given":"Rebecca","family":"Leary","sequence":"additional","affiliation":[{"name":"John Walton Muscular Dystrophy Research Centre Faculty of Medical Sciences Newcastle University  Newcastle upon Tyne UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sin\u00e9ad","family":"Nally","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals  Dublin Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9046-3540","authenticated-orcid":false,"given":"Volker","family":"Straub","sequence":"additional","affiliation":[{"name":"John Walton Muscular Dystrophy Research Centre Faculty of Medical Sciences Newcastle University  Newcastle upon Tyne UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,11,5]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"European Medicines Agency and its Paediatric Committee.2017 Commission Report on the Paediatric Regulation. 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