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dc.contributor.authorHind, Daniel
dc.contributor.authorReeves, BC
dc.contributor.authorBathers, S
dc.contributor.authorBray, C
dc.contributor.authorCorkhill, A
dc.contributor.authorHayward, C
dc.contributor.authorHarper, L
dc.contributor.authorNapp, V
dc.contributor.authorNorrie, J
dc.contributor.authorSpeed, C
dc.contributor.authorTremain, L
dc.contributor.authorKeat, N
dc.contributor.authorBradburn, M

BACKGROUND: The costs of medical research are a concern. Clinical Trials Units (CTUs) need to better understand variations in the costs of their activities. METHODS: Representatives of ten CTUs and two grant-awarding bodies pooled their experiences in discussions over 1.5 years. Five of the CTUs provided estimates of, and written justification for, costs associated with CTU activities required to implement an identical protocol. The protocol described a 5.5-year, nonpharmacological randomized controlled trial (RCT) conducted at 20 centres. Direct and indirect costs, the number of full time equivalents (FTEs) and the FTEs attracting overheads were compared and qualitative methods (unstructured interviews and thematic analysis) were used to interpret the results. Four members of the group (funding-body representatives or award panel members) reviewed the justification statements for transparency and information content. Separately, 163 activities common to trials were assigned to roles used by nine CTUs; the consistency of role delineation was assessed by Cohen's κ. RESULTS: Median full economic cost of CTU activities was £769,637 (range: £661,112 to £1,383,323). Indirect costs varied considerably, accounting for between 15% and 59% (median 35%) of the full economic cost of the grant. Excluding one CTU, which used external statisticians, the total number of FTEs ranged from 2.0 to 3.0; total FTEs attracting overheads ranged from 0.3 to 2.0. Variation in directly incurred staff costs depended on whether CTUs: supported particular roles from core funding rather than grants; opted not to cost certain activities into the grant; assigned clerical or data management tasks to research or administrative staff; employed extensive on-site monitoring strategies (also the main source of variation in non-staff costs). Funders preferred written justifications of costs that described both FTEs and indicative tasks for funded roles, with itemised non-staff costs. Consistency in role delineation was fair (κ = 0.21-0.40) for statisticians/data managers and poor for other roles (κ < 0.20). CONCLUSIONS: Some variation in costs is due to factors outside the control of CTUs such as access to core funding and levels of indirect costs levied by host institutions. Research is needed on strategies to control costs appropriately, especially the implementation of risk-based monitoring strategies.

dc.publisherSpringer Science and Business Media LLC
dc.subjectCost Control
dc.subjectCost-Benefit Analysis
dc.subjectMulticenter Studies as Topic
dc.subjectRandomized Controlled Trials as Topic
dc.subjectResearch Design
dc.subjectResearch Support as Topic
dc.subjectUnited Kingdom
dc.titleComparative costs and activity from a sample of UK clinical trials units
dc.typeJournal Article
dc.typeResearch Support, Non-U.S. Gov't
plymouth.organisational-group/Plymouth/Faculty of Health
plymouth.organisational-group/Plymouth/Research Groups
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS
plymouth.organisational-group/Plymouth/Research Groups/Plymouth Institute of Health and Care Research (PIHR)
plymouth.organisational-group/Plymouth/Users by role
dc.rights.embargoperiodNot known
rioxxterms.typeJournal Article/Review

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