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

Lookup NU author(s): Professor James WasonORCiD, Dr Nina WilsonORCiD, Professor Helen Hancock, Rebecca Maier



This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


© 2022, The Author(s).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.

Publication metadata

Author(s): Wason JMS, Dimairo M, Biggs K, Bowden S, Brown J, Flight L, Hall J, Jaki T, Lowe R, Pallmann P, Pilling MA, Snowdon C, Sydes MR, Villar SS, Weir CJ, Wilson N, Yap C, Hancock H, Maier R

Publication type: Article

Publication status: Published

Journal: BMC Medicine

Year: 2022

Volume: 20

Issue: 1

Print publication date: 01/12/2022

Online publication date: 10/08/2022

Acceptance date: 20/06/2022

Date deposited: 16/09/2022

ISSN (electronic): 1741-7015

Publisher: BioMed Central Ltd


DOI: 10.1186/s12916-022-02445-7


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Funder referenceFunder name
National Institute for Health Research