National Coordinating Centre for Research Methodology; Medical Research Council, UK Department of Health; Chief Scientist OfficeNot peer reviewedPublisher PD

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A Hamilton Brown

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A Pearl

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AB Benson

AB Kornblith

Adrian M Grant

Alison M McDonald

AM McDonald

B Djulbegovic

BM Psaty

C Langley

C May

C Ross

CD Hanning

CD Mitchell

CJ Baines

CJ Dickinson

Claire Snowdon

CR May

D Layder

D Weatherall

DA de Vaus

David Francis

Diana R Elbourne

E Grunfeld

E Smith

EJ Emanuel

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H Moses

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Ian Roberts

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KM Taylor

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M Seymour

M Watson

Marion K Campbell

MC Klein

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NA Patsopoulos

National Institute for Clinical Excellence

NK Aaronson

P Murchie

PM Ellis

PW Rose

Rosemary C Knight

S Gates

S Joffe

S Lewis

S Mayor

S Ross

S Shea

S Ziebland

SG Gowers

SS Chopra

T Bodenheimer

TB Drueke

V Peto

Vikki A Entwistle

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

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.</p

Grant Adrian M

Francis David

Entwistle Vikki A

Campbell Marion K

Garcia Jo

Elbourne Diana R

Snowdon Claire

Knight Rosemary C

McDonald Alison M

Roberts Ian

Directory of Open Access Journals

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Snowdon, Claire

Elbourne, Diana

Campbell, Marion

Entwistle, Vicky

Grant, Adrian

Francis, David

Knight, Rosemary

McDonald, Alison

Roberts, Ian

Garcia, Jo

Institute of Education EPrints

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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

Elbourne, Diana R

Campbell, Marion K

Entwistle, Vikki A

Grant, Adrian M

Knight, Rosemary C

McDonald, Alison M

LSHTM Research Online

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

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

Elbourne, Diana R.

Campbell, Marion K.

Entwistle, Vikki A.

Grant, Adrian M.

Knight, Rosemary C.

MacDonald, Alison M.

University of Brighton Research Portal

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

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

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