Evidence map›Paper›PMID 29310685›Full record

ArticleTrials2018

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

Lelia Duley, Alexa Gillman, Marian Duggan, Stephanie Belson, Jill Knox, Alison McDonald, Charlotte Rawcliffe, Joanne Simon, Tim Sprosen, Jude Watson and 1 more

Abstract read
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Lelia DuleyNottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK. lelia.duley@nottingham.ac.uk.ORCID http://orcid.org/0000-0001-6721-5178
Alexa GillmanClinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.
Marian DugganCancer Research UK & UCL Cancer Trials Centre, London, UK.
Stephanie BelsonFormerly of Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.
Jill KnoxBarts Clinical Trials Unit, Queen Mary University of London, London, UK.
Alison McDonaldCentre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
Charlotte RawcliffeCancer Research UK, Liverpool Cancer Trials Unit, University of Liverpool, Liverpool, UK.
Joanne SimonFormerly of Bristol Randomised Trial Collaboration, University of Bristol, Bristol, UK.
Tim SprosenOxford Clinical Trial Service Unit & Epidemiological Studies Unit, University of Oxford, Oxford, UK.
Jude WatsonYork Trials Unit, University of York, York, UK.
Wendy WoodNIHR RDS South Central, University of Southampton, Southampton, UK.

Funding

Cancer Research UK 15955Cancer Research UK 15957Chief Scientist Office HSRU1Department of Health RP-PG-0609-10107Medical Research Council G116/98
6 · The paper itself

Abstract

backgroundThe 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.

methodsRespondents 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.

resultsThere 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%).

conclusionsRecommendations 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.

Indexed as

Efficiency, OrganizationalResearch DesignWorkflowClinical Trials as TopicContractsEndpoint DeterminationHealth Care SurveysHumansPatient SelectionRegistriesResearch PersonnelResearch Support as TopicSample SizeStakeholder ParticipationTime FactorsUnited KingdomClinical trials unitInefficienciesMulticentre trialsRandomised trialsSurveyTrial conduct

Identifiers

PMID29310685
PMCPMC5759880

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.