Practical guidance for planning resources required to support publicly-funded adaptive clinical trials

Posted on 2022-08-10 - 06:30
Abstract Adaptive 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.


Wason, James M. S.; Dimairo, Munyaradzi; Biggs, Katie; Bowden, Sarah; Brown, Julia; Flight, Laura; et al. (2022): Practical guidance for planning resources required to support publicly-funded adaptive clinical trials. figshare. Collection.
Select your citation style and then place your mouse over the citation text to select it.



Usage metrics

BMC Medicine


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
Rebecca Maier
need help?