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

Hind, Daniel; Reeves, Barnaby C; Bathers, Sarah; Bray, Colin J.; Corkhill, Andrea; Hayward, Christopher; Harper, Lynda; Napp, Vicky; Norrie, John; Speed, Chris; Tremain, Liz; Keat, Nicola; Bradburn, Mike

doi:10.1186/s13063-017-1934-3

Cited by 27 publications

(20 citation statements)

References 54 publications

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“…Our experience on more recent trials is that these two tools may considerably underestimate the research nurse time necessary to undertake essential research procedures, threatening the success of the recruitment effort and the integrity of research data. Published workload models estimating staff resource for RCTs [74–79] are often criticised for over-simplicity, and their use can lead to staff burnout and poor implementation [80–82]. The rise of surgical trainee networks in the UK as a force in recruitment may go some way to compensating for the pressures on costs in public sector research, where trainees can be incentivised and co-ordinated to recruit and follow up study participants [83].…”

Section: Discussionmentioning

confidence: 99%

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

Biggs

Hind

Bradburn

et al. 2019

Trials

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BackgroundIncreasingly, pragmatic randomised controlled trials are being used to evaluate surgical interventions, although they present particular difficulties in regards to recruitment and retention.MethodsProcedures 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.ResultsForecasting 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.ConclusionsThis 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.Trial registrationISRCTN, ISRCTN41394716. Registered on 10 May 2012.UKCRN Study ID: 12486.

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Section: Discussionmentioning

confidence: 99%

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

Biggs

Hind

Bradburn

et al. 2019

Trials

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“…As the information available in the public domain on the sponsor cost of a trial is limited to clinical trial units in the UK [32], we based our sponsor costs on the past real-life experience of the authors: together we have about 100 years of experience in managing clinical trials in the biopharmaceutical industry, a contract research organisation (CRO), hospitals and an academic sponsor organisation. In addition, the initial tool was fine-tuned based on consultancy provided by an experienced former director of a CRO (BV, see Acknowledgements).…”

Section: Methodsmentioning

confidence: 99%

Budgeting of non-commercial clinical trials: development of a budget tool by a public funding agency

Nevens

Verleye

et al. 2019

Trials

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BackgroundInvestigator-led multicentre randomised trials are essential to generate evidence on the optimal use of medical interventions. These non-commercial trials are often hampered by underfunding, which may lead to difficulties in gathering a team with the necessary expertise, a delayed trial start, slow recruitment and even early trial discontinuation. As a new public funder of pragmatic clinical trials, the KCE Trials programme was committed to correctly pay all trial activities in order to assure timely delivery of high-quality trial results. As no appropriate trial budget tool was readily publicly available that took into account the costs for the sponsor as well as the costs for participating sites, we developed a tool to make the budgeting of a clinical trial efficient, transparent and fair across applicants.MethodsAll trial-related activities of the sponsor and sites were categorised, and cost drivers were identified. All elements were included in a spreadsheet tool allowing the sponsor team to calculate in detail the various activities of a clinical trial and to appreciate the budget impact of specific cost drivers, e.g. a delay in recruitment. Hourly fees by role were adapted from published data. Fixed amounts per activity were developed when appropriate.ResultsThis publicly available tool has already been used for 17 trials funded since the start of the KCE Trials programme in 2016, and it continues to be used and improved. This budget tool is used together with additional risk-reducing measures such as a multistep selection process with advance payments, a recruitment feasibility check by sponsor and funder, a close monitoring of study progress and a milestone-based payment schedule with the last payment made when the manuscript is submitted.ConclusionsThe budget tool helps the KCE Trials programme to answer relevant research questions in a timely way, within budget and with high quality, a necessary condition to achieve impact of this programme for patients, clinical practice and healthcare payers.

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“…the practical management of clinical trials research [15]. However, research in both the USA and UK has demonstrated that CTUs have markedly different histories and infrastructure, which impact on the ways that they manage clinical trials [16,17].…”

Section: Introductionmentioning

confidence: 99%

Learning from a Feasibility Trial of a Simple Intervention: Is Research a Barrier to Service Delivery, or is Service Delivery a Barrier to Research?

Frost¹,

Britten²

2020

Healthcare

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1) Background: Applied health services research (AHSR) relies upon coordination across multiple organizational boundaries. Our aim was to understand how competing organizational and professional goals enhance or impede the conduct of high quality AHSR. (2) Methods: A qualitative study was conducted in two local health care systems in the UK, linked to a feasibility trial of a clinic-based intervention in secondary care. Data collection involved 24 semi-structured interviews with research managers, clinical research staff, health professionals, and patients. (3) Results: This study required a dynamic network of interactions between heterogeneous health and social care stakeholders, each characterized by differing ways of organizing activities which constitute their core functions; cultures of collaboration and interaction and understanding of what research involves and how it contributes to patient care. These interrelated factors compounded the occupational and organizational boundaries that hindered communication and coordination. (4) Conclusions: Despite the strategic development of multiple organizations to foster inter-professional collaboration, the competing goals of research and clinical practice can impede the conduct of high quality AHSR. To remedy this requires the alignment and streamlining of organizational goals, so that all agencies involved in AHSR develop a shared understanding and mutual respect for the progress of evidence-based medicine and the complex and often nuanced environments in which it is created and practiced.

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

Cited by 27 publications

References 54 publications

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

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

Budgeting of non-commercial clinical trials: development of a budget tool by a public funding agency

Learning from a Feasibility Trial of a Simple Intervention: Is Research a Barrier to Service Delivery, or is Service Delivery a Barrier to Research?

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