Wason, James M. S. and Dimairo, Munyaradzi and Biggs, Katie and Bowden, Sarah and Brown, Julia and Flight, Laura and Hall, Jamie and Jaki, Thomas and Lowe, Rachel and Pallmann, Philip and Pilling, Mark A. and Snowdon, Claire and Sydes, Matthew R. and Villar, Sofía S. and Weir, Christopher J. and Wilson, Nina and Yap, Christina and Hancock, Helen and Maier, Rebecca (2022) Practical guidance for planning resources required to support publicly-funded adaptive clinical trials. BMC Medicine, 20 (1): 254. ISSN 1741-7015
Full text not available from this repository.Abstract
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.