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      What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies

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          Abstract

          Background

          A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme.

          Methods

          The cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fisher's exact test where appropriate.

          Results

          Less than a third (31%) of the trials achieved their original recruitment target and half (53%) were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41%) trials and early recruitment problems were identified in 77 (63%) trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed.

          Conclusion

          Recruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds). While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone.

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          Most cited references14

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          Practical statistics for medical research

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            Clinical trials: a practical approach

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              Ethical issues in the design and conduct of cluster randomised controlled trials.

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                Author and article information

                Journal
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                2006
                7 April 2006
                : 7
                : 9
                Affiliations
                [1 ]Health Services Research Unit, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, UK
                [2 ]Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK
                [3 ]Centre for Research and Innovation Management, Brighton
                Article
                1745-6215-7-9
                10.1186/1745-6215-7-9
                1475627
                16603070
                9cb0a107-e6f1-4bf8-b207-4fdf05d88f18
                Copyright © 2006 McDonald et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                Categories
                Research

                Medicine
                Medicine

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