Comparative costs and activity from a sample of UK clinical trials units

Autor: Christopher Bray, Nicola Keat, Lynda Harper, Chris Speed, Christopher Hayward, Barnaby C Reeves, Andrea Corkhill, Liz Tremain, Sarah Bathers, Vicky Napp, John Norrie, Mike Bradburn, Daniel Hind
Rok vydání: 2017
Předmět:
Zdroj: Hind, D, Reeves, B, Bathers, S, Bray, C, Corkhill, A, Hayward, C, Harper, L, Napp, V, Norrie, J, Speed, C, Treamain, L, Keat, N & Bradburn, M J 2017, ' Comparative costs and activity from a sample of UK clinical trials units ', Trials, vol. 18, 203 . https://doi.org/10.1186/s13063-017-1934-3
Hind, D, Reeves, B C, Bathers, S, Bray, C, Corkhill, A, Hayward, C, Harper, L, Napp, V, Norrie, J, Speed, C, Tremain, L, Keat, N & Bradburn, M 2017, ' Comparative costs and activity from a sample of UK clinical trials units ', Trials, vol. 18, no. 1, pp. 203 . https://doi.org/10.1186/s13063-017-1934-3
Trials
Trials, Vol 18, Iss 1, Pp 1-11 (2017)
ISSN: 1745-6215
Popis: 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
Databáze: OpenAIRE
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