• James M S Wason, Munyaradzi Dimairo, Katie Biggs, Sarah Bowden, Julia Brown, Laura Flight, Jamie Hall, Thomas Jaki, Rachel Lowe, Philip Pallmann, Mark A Pilling, Claire Snowdon, Matthew R Sydes, Sofía S Villar, Christopher J Weir, Nina Wilson, Christina Yap, Helen Hancock, and Rebecca Maier.
• Biostatistics Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK. james.wason@newcastle.ac.uk.
• Bmc Med. 2022 Aug 10; 20 (1): 254254.

AbstractAdaptive designs are a class of methods for improving efficiency and patient benefit of clinical trials. Although their use has increased in recent years, research suggests they are not used in many situations where they have potential to bring benefit. One barrier to their more widespread use is a lack of understanding about how the choice to use an adaptive design, rather than a traditional design, affects resources (staff and non-staff) required to set-up, conduct and report a trial. The Costing Adaptive Trials project investigated this issue using quantitative and qualitative research amongst UK Clinical Trials Units. Here, we present guidance that is informed by our research, on considering the appropriate resourcing of adaptive trials. We outline a five-step process to estimate the resources required and provide an accompanying costing tool. The process involves understanding the tasks required to undertake a trial, and how the adaptive design affects them. We identify barriers in the publicly funded landscape and provide recommendations to trial funders that would address them. Although our guidance and recommendations are most relevant to UK non-commercial trials, many aspects are relevant more widely.© 2022. The Author(s).

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