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

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

Design, planning and implementation lessons learnt from a surgical multi-centre randomised controlled trial

Background Increasingly, pragmatic randomised controlled trials are being used to evaluate surgical interventions, although they present particular difficulties in regards to recruitment and retention. Methods Procedures and processes related to implementation of a multi-centre pragmatic surgical randomised controlled trial are discussed. In this surgical trial, forecasting of consent rates based on similar trials and micro-costing of study activities with research partners were undertaken and a video was produced targeting recruiting staff with the aim of aiding recruitment. The baseline assessments were reviewed to ensure the timing did not impact on the outcome. Attrition due to procedure waiting time was monitored and data were triangulated for the primary outcome to ensure adequate follow-up data. Results Forecasting and costing ensured that the recruitment window was of adequate length and adequate resource was available for study procedures at multiple clinics in each hospital. Recruiting staff found the recruitment video useful. The comparison of patient-reported data collected prior to randomisation and prior to treatment provided confidence in the baseline data. Knowledge of participant dropout due to delays in treatment meant we were able to increase the recruitment target in a timely fashion, and along with the triangulation of data sources, this ensured adequate follow-up of randomised participants. Conclusions This paper provides a range of evidence-based and experience-based approaches which, collectively, resulted in meeting our study objectives and from which lessons may be transferable

Plans to Stop Cancer Screening Tests Among Adults Who Recently Considered Screening

We sought to estimate what proportion of adults plan to stop cancer screening tests among adults who recently considered screening and to explore factors associated with these screening plans