The University of Southampton
University of Southampton Institutional Repository

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
db76a61c-94d8-4ec8-82cd-d7baca16f665
Gillman, Alexa
ffb3db21-f6f9-436b-90a1-1356c470fa8b
Duggan, Marian
844079cc-6d10-40d4-9d3a-801cd44dafc3
Belson, Stephanie
1b4a3eda-2199-4e64-8d4a-d687a4ad3a5c
Knox, Jill
111c2dfe-ffbc-4c7b-827f-e8adda64d8e7
McDonald, Alison
cae22c01-babd-4b00-834e-fcb7fd8c4646
Rawcliffe, Charlotte
4008880c-3599-457d-8173-9a84c171e3e9
Simon, Joanne
f361eda1-1660-44b3-8191-a5348b0586dc
Sprosen, Tim
f6721d4e-816b-4594-851f-7f43927b0532
Watson, Jude
881a91b3-a541-406a-ba8a-466792cb50f9
Wood, Wendy
c7e12f30-5332-4717-a0c8-328775e06364
Duley, Lelia
db76a61c-94d8-4ec8-82cd-d7baca16f665
Gillman, Alexa
ffb3db21-f6f9-436b-90a1-1356c470fa8b
Duggan, Marian
844079cc-6d10-40d4-9d3a-801cd44dafc3
Belson, Stephanie
1b4a3eda-2199-4e64-8d4a-d687a4ad3a5c
Knox, Jill
111c2dfe-ffbc-4c7b-827f-e8adda64d8e7
McDonald, Alison
cae22c01-babd-4b00-834e-fcb7fd8c4646
Rawcliffe, Charlotte
4008880c-3599-457d-8173-9a84c171e3e9
Simon, Joanne
f361eda1-1660-44b3-8191-a5348b0586dc
Sprosen, Tim
f6721d4e-816b-4594-851f-7f43927b0532
Watson, Jude
881a91b3-a541-406a-ba8a-466792cb50f9
Wood, Wendy
c7e12f30-5332-4717-a0c8-328775e06364

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) (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.

Text document-2 - Version of Record
Available under License Creative Commons Attribution.
Download (836kB)

More information

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: https://eprints.soton.ac.uk/id/eprint/417423
ISSN: 1745-6215
PURE UUID: 0134baa5-e038-43ab-b6d2-a424caabce94

Catalogue record

Date deposited: 31 Jan 2018 17:30
Last modified: 14 Feb 2018 17:31

Export record

Altmetrics

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

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Library staff edit
Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of https://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×