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Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project by Nina Wilson; Katie Biggs; Sarah Bowden; Julia Brown; Munyaradzi Dimairo; Laura Flight; Jamie Hall; Anna Hockaday; Thomas Jaki; Rachel Lowe; Caroline Murphy; Philip Pallmann; Mark A. Pilling; Claire Snowdon; Matthew R. Sydes; Sofía S. Villar; Christopher J. Weir; Jessica Welburn; Christina Yap; Rebecca Maier; Helen Hancock; James M. S. Wason is a Medicine article available to read on EtoBox.

What is Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project about?

## Abstract ## Background Adaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials. An important barrier to further increased use is a lack of understanding about which additional resources are required to conduct a high-quality adaptive clinical trial, compared to a traditional fixed design. The Costing Adaptive Trials (CAT) project investigated which additional resources may be required to support adaptive trials. ## Methods We conducted a mock costing exercise amongst seven Clinical Trials Units (CTUs) in the UK. Five scenarios were developed, derived from funded clinical trials, where a non-adaptive version and an adaptive version were described. Each scenario represented a different type of adaptive design. CTU staff were asked to provide the costs and staff time they estimated would be needed to support the trial, categorised into specified areas (e.g. statistics, data management, trial management). This was calculated separately for the non-adaptive and adaptive version of the trial, allowing paired comparisons. Interviews with 10 CTU staff who had completed the costing exercise were conducted by qualitative researchers to explo

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Author

Nina Wilson; Katie Biggs; Sarah Bowden; Julia Brown; Munyaradzi Dimairo; Laura Flight; Jamie Hall; Anna Hockaday; Thomas Jaki; Rachel Lowe; Caroline Murphy; Philip Pallmann; Mark A. Pilling; Claire Snowdon; Matthew R. Sydes; Sofía S. Villar; Christopher J. Weir; Jessica Welburn; Christina Yap; Rebecca Maier; Helen Hancock; James M. S. Wason

Publisher

Springer Science and Business Media LLC

Published

2021

Language

EN

Field

Medicine (Health Sciences)