title: Getting our house in order: an audit of the registration and publication of clinical trials supported by the National Institute for Health Research Oxford Biomedical Research Centre and the Musculoskeletal Biomedical Research Unit.
abstract: OBJECTIVE
  To audit the proportion of clinical trials that had been publically registered and, of the completed trials, the proportion published.
  
  
  METHODS
  2 major research institutions supported by the National Institute of Health Research (NIHR).
  
  
  METHODS
  The proportion of trials reporting results within 12 months, 24 months and 'ever'. Factors associated with non-publication were analysed using logistic regression.
  
  
  METHODS
  Phases 2-4 clinical trials identified from internal documents and publication lists.
  
  
  RESULTS
  In total, 286 trials were identified. We could not find registration for 4 (1.4%) of these, all of which were completed and published. Of the trials with a registered completion date pre-January 2015, just over half (56%) were published, and half of these were published within 12 months (36/147, 25%). For some trials, information on the public registers was found to be out-of-date and/or inaccurate. No clinical trial characteristics were found to be significantly associated with non-publication. We have produced resources to facilitate similar audits elsewhere.
  
  
  CONCLUSIONS
  It was feasible to conduct an internal audit of registration and publication in 2 major research institutions. Performance was similar to, or better than, comparable cohorts of trials sampled from registries. The major resource input required was manually seeking information: if all registry entries were maintained, then almost the entire process of audit could be automated--and routinely updated--for all research centres and funders.
authors.affiliation: Nuffield Department of Primary Care Health Sciences, The Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK.
authors.forename: A C
authors.initials: AC
authors.lastname: Tompson
authors.affiliation: National Institute of Health Research Oxford Biomedical Research Centre and Unit, Oxford University Hospitals NHS Trust, Oxford, UK.
authors.forename: S
authors.initials: S
authors.lastname: Petit-Zeman
authors.affiliation: Nuffield Department of Primary Care Health Sciences, The Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK.
authors.forename: B
authors.initials: B
authors.lastname: Goldacre
authors.affiliation: Nuffield Department of Primary Care Health Sciences, The Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK.
authors.forename: C J
authors.initials: CJ
authors.lastname: Heneghan
mesh_terms: D000047:Academies and Institutes / Q000458:organization & administration*; D054869:Clinical Audit; D002986:Clinical Trials as Topic / Q000592:standards*; D017594:Publication Bias; D011642:Publications / Q000592:standards*; D012042:Registries / Q000592:standards*; D012189:Retrospective Studies; D006113:United Kingdom
keywords: PUBLIC HEALTH; STATISTICS & RESEARCH METHODS