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Early phase clinical trials extension to guidelines for the content of statistical analysis plans.

dc.contributor.authorHomer, V
dc.contributor.authorYap, C
dc.contributor.authorBond, S
dc.contributor.authorHolmes, J
dc.contributor.authorStocken, D
dc.contributor.authorWalker, K
dc.contributor.authorRobinson, EJ
dc.contributor.authorWheeler, G
dc.contributor.authorBrown, S
dc.contributor.authorHinsley, S
dc.contributor.authorSchipper, M
dc.contributor.authorWeir, CJ
dc.contributor.authorRantell, K
dc.contributor.authorPrior, T
dc.contributor.authorYu, L-M
dc.contributor.authorKirkpatrick, J
dc.contributor.authorBedding, A
dc.contributor.authorGamble, C
dc.contributor.authorGaunt, P
dc.date.accessioned2022-04-27T12:12:20Z
dc.date.available2022-04-27T12:12:20Z
dc.date.issued2022-02-07
dc.identifier.citationBMJ (Clinical research ed.), 2022, 376 pp. e068177 - ?
dc.identifier.issn0959-8138
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/5099
dc.identifier.eissn1756-1833
dc.identifier.eissn1756-1833
dc.identifier.doi10.1136/bmj-2021-068177
dc.identifier.doi10.1136/bmj-2021-068177
dc.description.abstractThis paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, ensuring specification of the minimum reporting analysis requirements, by detailing extensions (11 new items) and modifications (25 items) to existing guidance after a review by various stakeholders.
dc.formatElectronic
dc.format.extente068177 - ?
dc.languageeng
dc.language.isoeng
dc.publisherBMJ PUBLISHING GROUP
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectClinical Trials as Topic
dc.subjectGuidelines as Topic
dc.subjectData Analysis
dc.titleEarly phase clinical trials extension to guidelines for the content of statistical analysis plans.
dc.typeJournal Article
dcterms.dateAccepted2022-01-10
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1136/bmj-2021-068177
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by-nc/4.0
rioxxterms.licenseref.startdate2022-02-07
dc.relation.isPartOfBMJ (Clinical research ed.)
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.publication-statusPublished
pubs.volume376
pubs.embargo.termsNot known
icr.researchteamClinical Trials & Statistics Unit
dc.contributor.icrauthorYap, Christina


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