Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Jan 8;19(1):15.
doi: 10.1186/s13063-017-2378-5.

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

Lelia Duley  1 , Alexa Gillman  2 , Marian Duggan  3 , Stephanie Belson  4 , Jill Knox  5 , Alison McDonald  6 , Charlotte Rawcliffe  7 , Joanne Simon  8 , Tim Sprosen  9 , Jude Watson  10 , Wendy Wood  11
Affiliations

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

Lelia Duley et al. Trials. .

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.

Keywords: Clinical trials unit; Inefficiencies; Multicentre trials; Randomised trials; Survey; Trial conduct.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Inefficiencies between grant award and recruitment of first participant. CLRN, comprehensive local research network; IMP, investigational medicinal product; IT, information technology; R&D, research and development
Fig. 2
Fig. 2
Inefficiencies between recruitment of first participant and publication of trial results. CRF, case report form; PIL, participant information leaflet
See this image and copyright information in PMC

References

    1. Al-Shahi Salman R, Beller E, Kagan J, Hemminki E, Phillips RS, Savulescu J, Macleod M, Wisely J, Chalmers I. Increasing value and reducing waste in biomedical research regulation and management. Lancet. 2014;383(9912):176–85. doi: 10.1016/S0140-6736(13)62297-7. - DOI - PMC - PubMed
    1. Treweek S, Altman DG, Bower P, Campbell M, Chalmers I, Cotton S, Craig P, Crosby D, Davidson P, Devane D, et al. Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform. Trials. 2015;16:261. doi: 10.1186/s13063-015-0776-0. - DOI - PMC - PubMed
    1. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374(9683):86–9. doi: 10.1016/S0140-6736(09)60329-9. - DOI - PubMed
    1. Chalmers I, Bracken MB, Djulbegovic B, Garattini S, Grant J, Gulmezoglu AM, Howells DW, Ioannidis JP, Oliver S. How to increase value and reduce waste when research priorities are set. Lancet. 2014;383(9912):156–65. doi: 10.1016/S0140-6736(13)62229-1. - DOI - PubMed
    1. Yordanov Y, Dechartres A, Porcher R, Boutron I, Altman DG, Ravaud P. Avoidable waste of research related to inadequate methods in clinical trials. BMJ. 2015;350:h809. doi: 10.1136/bmj.h809. - DOI - PMC - PubMed

MeSH terms