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What are the main inefficiencies in trial conduct: A survey of UKCRC registered clinical trials units in the UK

What are the main inefficiencies in trial conduct: A survey of UKCRC registered clinical trials units in the UK
What are the main inefficiencies in trial conduct: A survey of UKCRC registered clinical trials units in the UK

Background: The UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Units (CTUs) Network aims to support high-quality, efficient and sustainable clinical trials research in the UK. To better understand the challenges in efficient trial conduct, and to help prioritise tackling these challenges, we surveyed CTU staff. The aim was to identify important inefficiencies during two key stages of the trial conduct life cycle: (i) from grant award to first participant, (ii) from first participant to reporting of final results. Methods: Respondents were asked to list their top three inefficiencies from grant award to recruitment of the first participant, and from recruitment of the first participant to publication of results. Free text space allowed respondents to explain why they thought these were important. The survey was constructed using SurveyMonkey and circulated to the 45 registered CTUs in May 2013. Respondents were asked to name their unit and job title, but were otherwise anonymous. Free-text responses were coded into broad categories. Results: There were 43 respondents from 25 CTUs. The top inefficiency between grant award and recruitment of first participant was reported as obtaining research and development (R&D) approvals by 23 respondents (53%), contracts by 22 (51%), and other approvals by 13 (30%). The top inefficiency from recruitment of first participant to publication of results was failure to meet recruitment targets, reported by 19 (44%) respondents. A common comment was that this reflected overoptimistic or inaccurate estimates of recruitment at site. Data management, including case report form design and delays in resolving data queries with sites, was reported as an important inefficiency by 11 (26%) respondents, and preparation and submission for publication by 9 (21%). Conclusions: Recommendations for improving the efficiency of trial conduct within the CTUs network include: further reducing unnecessary bureaucracy in approvals and contracting; improving training for site staff; realistic recruitment targets and appropriate feasibility; developing training across the network; improving the working relationships between chief investigators and units; encouraging funders to release sufficient funding to allow prompt recruitment of trial staff; and encouraging more research into how to improve the efficiency and quality of trial conduct.

Clinical trials unit, Inefficiencies, Multicentre trials, Randomised trials, Survey, Trial conduct
1745-6215
Duley, Lelia
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Gillman, Alexa
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Duggan, Marian
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Belson, Stephanie
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Knox, Jill
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McDonald, Alison
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Rawcliffe, Charlotte
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Simon, Joanne
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Sprosen, Tim
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Watson, Jude
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Wood, Wendy
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Duley, Lelia
db76a61c-94d8-4ec8-82cd-d7baca16f665
Gillman, Alexa
ffb3db21-f6f9-436b-90a1-1356c470fa8b
Duggan, Marian
844079cc-6d10-40d4-9d3a-801cd44dafc3
Belson, Stephanie
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Knox, Jill
111c2dfe-ffbc-4c7b-827f-e8adda64d8e7
McDonald, Alison
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Rawcliffe, Charlotte
4008880c-3599-457d-8173-9a84c171e3e9
Simon, Joanne
f361eda1-1660-44b3-8191-a5348b0586dc
Sprosen, Tim
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Watson, Jude
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Wood, Wendy
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Duley, Lelia, Gillman, Alexa, Duggan, Marian, Belson, Stephanie, Knox, Jill, McDonald, Alison, Rawcliffe, Charlotte, Simon, Joanne, Sprosen, Tim, Watson, Jude and Wood, Wendy (2018) What are the main inefficiencies in trial conduct: A survey of UKCRC registered clinical trials units in the UK. Trials, 19 (1), [15]. (doi:10.1186/s13063-017-2378-5).

Record type: Article

Abstract

Background: The UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Units (CTUs) Network aims to support high-quality, efficient and sustainable clinical trials research in the UK. To better understand the challenges in efficient trial conduct, and to help prioritise tackling these challenges, we surveyed CTU staff. The aim was to identify important inefficiencies during two key stages of the trial conduct life cycle: (i) from grant award to first participant, (ii) from first participant to reporting of final results. Methods: Respondents were asked to list their top three inefficiencies from grant award to recruitment of the first participant, and from recruitment of the first participant to publication of results. Free text space allowed respondents to explain why they thought these were important. The survey was constructed using SurveyMonkey and circulated to the 45 registered CTUs in May 2013. Respondents were asked to name their unit and job title, but were otherwise anonymous. Free-text responses were coded into broad categories. Results: There were 43 respondents from 25 CTUs. The top inefficiency between grant award and recruitment of first participant was reported as obtaining research and development (R&D) approvals by 23 respondents (53%), contracts by 22 (51%), and other approvals by 13 (30%). The top inefficiency from recruitment of first participant to publication of results was failure to meet recruitment targets, reported by 19 (44%) respondents. A common comment was that this reflected overoptimistic or inaccurate estimates of recruitment at site. Data management, including case report form design and delays in resolving data queries with sites, was reported as an important inefficiency by 11 (26%) respondents, and preparation and submission for publication by 9 (21%). Conclusions: Recommendations for improving the efficiency of trial conduct within the CTUs network include: further reducing unnecessary bureaucracy in approvals and contracting; improving training for site staff; realistic recruitment targets and appropriate feasibility; developing training across the network; improving the working relationships between chief investigators and units; encouraging funders to release sufficient funding to allow prompt recruitment of trial staff; and encouraging more research into how to improve the efficiency and quality of trial conduct.

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Accepted/In Press date: 6 December 2017
e-pub ahead of print date: 8 January 2018
Keywords: Clinical trials unit, Inefficiencies, Multicentre trials, Randomised trials, Survey, Trial conduct

Identifiers

Local EPrints ID: 417423
URI: http://eprints.soton.ac.uk/id/eprint/417423
ISSN: 1745-6215
PURE UUID: 0134baa5-e038-43ab-b6d2-a424caabce94

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Date deposited: 31 Jan 2018 17:30
Last modified: 15 Mar 2024 18:11

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Contributors

Author: Lelia Duley
Author: Alexa Gillman
Author: Marian Duggan
Author: Stephanie Belson
Author: Jill Knox
Author: Alison McDonald
Author: Charlotte Rawcliffe
Author: Joanne Simon
Author: Tim Sprosen
Author: Jude Watson
Author: Wendy Wood

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