Compliance of clinical trial registries with the World Health Organization minimum data set: a survey

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dc.contributor.authorMoja, Lorenzoen_ZA
dc.contributor.authorMoschetti, Ivanen_ZA
dc.contributor.authorNurbhai, Muniraen_ZA
dc.contributor.authorCompagnoni, Annaen_ZA
dc.contributor.authorLiberati, Alessandroen_ZA
dc.contributor.authorGrimshaw, Jeremyen_ZA
dc.contributor.authorChan, An-Wenen_ZA
dc.contributor.authorDickersin, Kayen_ZA
dc.contributor.authorKrleza-Jeric, Karmelaen_ZA
dc.contributor.authorMoher, Daviden_ZA
dc.contributor.authorSim, Idaen_ZA
dc.contributor.authorVolmink, Jimmyen_ZA
dc.date.accessioned2015-11-04T12:01:19Z
dc.date.available2015-11-04T12:01:19Z
dc.date.issued2009en_ZA
dc.description.abstractBACKGROUND: Since September 2005 the International Committee of Medical Journal Editors has required that trials be registered in accordance with the World Health Organization (WHO) minimum dataset, in order to be considered for publication. The objective is to evaluate registries' and individual trial records' compliance with the 2006 version of the WHO minimum data set. METHODS: A retrospective evaluation of 21 online clinical trial registries (international, national, specialty, pharmaceutical industry and local) from April 2005 to February 2007 and a cross-sectional evaluation of a stratified random sample of 610 trial records from the 21 registries. RESULTS: Among 11 registries that provided guidelines for registration, the median compliance with the WHO criteria were 14 out of 20 items (range 6 to 20). In the period April 2005-February 2007, six registries increased their compliance by six data items, on average. None of the local registry websites published guidelines on the trial data items required for registration. Slightly more than half (330/610; 54.1%, 95% CI 50.1% - 58.1%) of trial records completed the contact details criteria while 29.7% (181/610, 95% CI 26.1% - 33.5%) completed the key clinical and methodological data fields. CONCLUSION: While the launch of the WHO minimum data set seemed to positively influence registries with better standardisation of approaches, individual registry entries are largely incomplete. Initiatives to ensure quality assurance of registries and trial data should be encouraged. Peer reviewers and editors should scrutinise clinical trial registration records to ensure consistency with WHO's core content requirements when considering trial-related publications.en_ZA
dc.identifier.apacitationMoja, L., Moschetti, I., Nurbhai, M., Compagnoni, A., Liberati, A., Grimshaw, J., ... Volmink, J. (2009). Compliance of clinical trial registries with the World Health Organization minimum data set: a survey. <i>Trials</i>, http://hdl.handle.net/11427/14692en_ZA
dc.identifier.chicagocitationMoja, Lorenzo, Ivan Moschetti, Munira Nurbhai, Anna Compagnoni, Alessandro Liberati, Jeremy Grimshaw, An-Wen Chan, et al "Compliance of clinical trial registries with the World Health Organization minimum data set: a survey." <i>Trials</i> (2009) http://hdl.handle.net/11427/14692en_ZA
dc.identifier.citationMoja, L. P., Moschetti, I., Nurbhai, M., Compagnoni, A., Liberati, A., Grimshaw, J. M., ... & Volmink, J. (2009). Compliance of clinical trial registries with the World Health Organization minimum data set: a survey. Trials, 10(1), 56.en_ZA
dc.identifier.ris TY - Journal Article AU - Moja, Lorenzo AU - Moschetti, Ivan AU - Nurbhai, Munira AU - Compagnoni, Anna AU - Liberati, Alessandro AU - Grimshaw, Jeremy AU - Chan, An-Wen AU - Dickersin, Kay AU - Krleza-Jeric, Karmela AU - Moher, David AU - Sim, Ida AU - Volmink, Jimmy AB - BACKGROUND: Since September 2005 the International Committee of Medical Journal Editors has required that trials be registered in accordance with the World Health Organization (WHO) minimum dataset, in order to be considered for publication. The objective is to evaluate registries' and individual trial records' compliance with the 2006 version of the WHO minimum data set. METHODS: A retrospective evaluation of 21 online clinical trial registries (international, national, specialty, pharmaceutical industry and local) from April 2005 to February 2007 and a cross-sectional evaluation of a stratified random sample of 610 trial records from the 21 registries. RESULTS: Among 11 registries that provided guidelines for registration, the median compliance with the WHO criteria were 14 out of 20 items (range 6 to 20). In the period April 2005-February 2007, six registries increased their compliance by six data items, on average. None of the local registry websites published guidelines on the trial data items required for registration. Slightly more than half (330/610; 54.1%, 95% CI 50.1% - 58.1%) of trial records completed the contact details criteria while 29.7% (181/610, 95% CI 26.1% - 33.5%) completed the key clinical and methodological data fields. CONCLUSION: While the launch of the WHO minimum data set seemed to positively influence registries with better standardisation of approaches, individual registry entries are largely incomplete. Initiatives to ensure quality assurance of registries and trial data should be encouraged. Peer reviewers and editors should scrutinise clinical trial registration records to ensure consistency with WHO's core content requirements when considering trial-related publications. DA - 2009 DB - OpenUCT DO - 10.1186/1745-6215-10-56 DP - University of Cape Town J1 - Trials LK - https://open.uct.ac.za PB - University of Cape Town PY - 2009 T1 - Compliance of clinical trial registries with the World Health Organization minimum data set: a survey TI - Compliance of clinical trial registries with the World Health Organization minimum data set: a survey UR - http://hdl.handle.net/11427/14692 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14692
dc.identifier.urihttp://dx.doi.org/10.1186/1745-6215-10-56
dc.identifier.vancouvercitationMoja L, Moschetti I, Nurbhai M, Compagnoni A, Liberati A, Grimshaw J, et al. Compliance of clinical trial registries with the World Health Organization minimum data set: a survey. Trials. 2009; http://hdl.handle.net/11427/14692.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDepartment of Public Health and Family Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2009 Moja et al; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceTrialsen_ZA
dc.source.urihttp://www.trialsjournal.com/en_ZA
dc.subject.otherClinical Trialsen_ZA
dc.subject.otherComplianceen_ZA
dc.titleCompliance of clinical trial registries with the World Health Organization minimum data set: a surveyen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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