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. Issue 3 (2nd March 2016)

• Record Type: Journal Article
• Authors: Tompson, A C; Petit-Zeman, S; Goldacre, B; Heneghan, C J
• Is Part Of: BMJ open. Volume 6:Issue 3(2016)
• Publication Date: 2016-03-02
• Subjects: PUBLIC HEALTH -- STATISTICS & RESEARCH METHODS; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2015-009285
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Objectives: To audit the proportion of clinical trials that had been publically registered and, of the completed trials, the proportion published. Setting: 2 major research institutions supported by the National Institute of Health Research (NIHR). Primary and secondary outcome measures: The proportion of trials reporting results within 12 months, 24 months and 'ever'. Factors associated with non-publication were analysed using logistic regression. Inclusion criteria: 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 For some trials, information on the public registers was found to be out-of-date and/or inaccurate.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.