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Developments in the design, conduct, and reporting of child health trials

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dc.contributor.authorBaba, Ami
dc.contributor.authorAregbesola, Alex
dc.contributor.authorCaldwell, Patrina H.Y.
dc.contributor.authorElliott, Sarah A.
dc.contributor.authorElsman, Ellen B.M.
dc.contributor.authorFernandes, Ricardo M.
dc.contributor.authorHartling, Lisa
dc.contributor.authorHeath, Anna
dc.contributor.authorKelly, Lauren E.
dc.contributor.authorPreston, Jennifer
dc.contributor.authorSammy, Adrian
dc.contributor.authorWebbe, James
dc.contributor.authorWilliams, Katrina
dc.contributor.authorWoolfall, Kerry
dc.contributor.authorKlassen, Terry P.
dc.contributor.authorOffringa, Martin
dc.date.accessioned2024-07-25T10:51:06Z
dc.date.available2024-07-25T10:51:06Z
dc.date.issued2024
dc.descriptionCopyright © 2024 by the American Academy of Pediatricspt_PT
dc.description.abstractTo identify priority areas to improve the design, conduct, and reporting of pediatric clinical trials, the international expert network, Standards for Research (StaR) in Child Health, was assembled and published the first 6 Standards in Pediatrics in 2012. After a recent review summarizing the 247 publications by StaR Child Health authors that highlight research practices that add value and reduce research "waste," the current review assesses the progress in key child health trial methods areas: consent and recruitment, containing risk of bias, roles of data monitoring committees, appropriate sample size calculations, outcome selection and measurement, and age groups for pediatric trials. Although meaningful change has occurred within the child health research ecosystem, measurable progress is still disappointingly slow. In this context, we identify and review emerging trends that will advance the agenda of increased clinical usefulness of pediatric trials, including patient and public engagement, Bayesian statistical approaches, adaptive designs, and platform trials. We explore how implementation science approaches could be applied to effect measurable improvements in the design, conducted, and reporting of child health research.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationPediatrics. 2024 Jul 1;154(1):e2024065799pt_PT
dc.identifier.doi10.1542/peds.2024-065799pt_PT
dc.identifier.eissn1098-4275
dc.identifier.issn0031-4005
dc.identifier.urihttp://hdl.handle.net/10451/65465
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherAAP Publicationspt_PT
dc.relation.publisherversionhttps://publications.aap.org/pediatricspt_PT
dc.subjectAdaptive designpt_PT
dc.subjectChild healthpt_PT
dc.subjectImplementation sciencept_PT
dc.subjectClinical trials data monitoring committeespt_PT
dc.subjectProton pump inhibitorspt_PT
dc.titleDevelopments in the design, conduct, and reporting of child health trialspt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue1pt_PT
oaire.citation.titlePediatricspt_PT
oaire.citation.volume154pt_PT
person.familyNameFernandes
person.givenNameRicardo
person.identifier309018
person.identifier.orcid0000-0002-7253-6475
person.identifier.ridC-7501-2015
person.identifier.scopus-author-id24436565500
rcaap.rightsrestrictedAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublication862be38f-2247-424c-b26c-d3bdda4474be
relation.isAuthorOfPublication.latestForDiscovery862be38f-2247-424c-b26c-d3bdda4474be

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