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

Wason, James M. S., Dimairo, Munyaradzi, Biggs, Katie, Bowden, Sarah, Brown, Julia, Flight, Laura, Hall, Jamie, Jaki, Thomas, Lowe, Rachel, Pallmann, Philip ORCID:, Pilling, Mark A, Snowdon, Claire, Sydes, Matthew R, Villar, Sofia S, Weir, Christopher J, Wilson, Nina, Yap, Christina, Hancock, Helen and Maier, Rebecca 2022. Practical guidance for planning resources required to support publicly‑funded adaptive clinical trials. BMC Medicine 20 , 254. 10.1186/s12916-022-02445-7

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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.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Centre for Trials Research (CNTRR)
Additional Information: This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.
Publisher: BioMed Central
ISSN: 1741-7015
Date of First Compliant Deposit: 11 August 2022
Date of Acceptance: 20 June 2022
Last Modified: 17 May 2023 00:22

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