Financial considerations in the conduct of multi-centre randomised controlled trials: rvidence from a qualitative study

Snowdon, Claire, Elbourne, Diana R., Garcia, Jo, Campbell, Marion K., Entwistle, Vikki A., Francis, David, Grant, Adrian M., Knight, Rosemary C., MacDonald, Alison M. and Roberts, Ian (2006) Financial considerations in the conduct of multi-centre randomised controlled trials: rvidence from a qualitative study Trials, 7 (34). ISSN 1745-6215

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Abstract

BACKGROUND - Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS). METHODS - In-depth semi-structured telephone interviews were conducted in 2003–04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti. RESULTS - The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion) were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA. CONCLUSION - This study highlights complex financial aspects of planning and conducting trials, especially where multiple funders are involved. Recognition of the importance of financial stability and of the need for appropriate training in this area should be paralleled by further similar research with a broader range of trials, aimed at understanding and facilitating the conduct of clinical research.

Item Type: Journal article
Additional Information: © 2006 Snowdon 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.
Uncontrolled Keywords: Medical trials; Innovation; CENTRIM
Subjects: N000 Business and Management > N200 Management studies > N210 Management techniques > N215 Change and Innovation
B000 Health Professions
DOI (a stable link to the resource): 10.1186/1745-6215-7-34
Faculties: Brighton Business School > Centre for Research in Innovation Management
Depositing User: editor centrim
Date Deposited: 15 Apr 2009
Last Modified: 07 Oct 2014 11:42
URI: http://eprints.brighton.ac.uk/id/eprint/5633

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