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

McDonald, Alison M, Knight, Rosemary C, Campbell, Marion K, Entwistle, Vikki A, Grant, Adrian M, Cook, Jonathan A, Elbourne, Diana R, Francis, David, Garcia, Jo, Roberts, Ian and Snowdon, Claire (2006) What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies Trials, 7 (9). ISSN 1745-6215

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Abstract

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. 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. 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. 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.

Item Type:Journal article
Additional Information:© 2006 MacDonald 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.
Subjects:N000 Business and Management > N200 Management studies > N210 Management techniques > N215 Change and Innovation
DOI (a stable link to the resource):10.1186/1745-6215-7-9
Faculties:Brighton Business School > Centre for Research in Innovation Management
ID Code:3396
Deposited By:editor centrim
Deposited On:09 Mar 2009
Last Modified:11 Jul 2013 11:50

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