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BMJ Open. 2016 Mar 2;6(3):e009285. doi: 10.1136/bmjopen-2015-009285.

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.

Author information

1
Nuffield Department of Primary Care Health Sciences, The Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK.
2
National Institute of Health Research Oxford Biomedical Research Centre and Unit, Oxford University Hospitals NHS Trust, Oxford, UK.

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 For some trials, information on the public registers was found to be out-of-date and/or inaccurate.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.

KEYWORDS:

PUBLIC HEALTH; STATISTICS & RESEARCH METHODS

PMID:
26936902
PMCID:
PMC4785314
DOI:
10.1136/bmjopen-2015-009285
[Indexed for MEDLINE]
Free PMC Article

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