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

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.

Metadata

Item Type:	Article
Authors/Creators:	Wason, J.M.S. Dimairo, M. Biggs, K. Bowden, S. Brown, J. Flight, L. https://orcid.org/0000-0002-9569-8290 Hall, J. https://orcid.org/0000-0003-4042-5591 Jaki, T. Lowe, R. Pallmann, P. Pilling, M.A. Snowdon, C. Sydes, M.R. Villar, S.S. Weir, C.J. Wilson, N. Yap, C. Hancock, H. Maier, R.
Copyright, Publisher and Additional Information:	© 2022 The Author(s). Open Access. 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. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Keywords:	Adaptive designs; Adaptive clinical trials; Clinical trials; Efficiency; Resource requirements; Trial coordination
Dates:	Published: 10 August 2022 Published (online): 10 August 2022 Accepted: 20 June 2022
Institution:	The University of Sheffield
Academic Units:	The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research
Funding Information:	Funder Grant number Department of Health and Social Care (DHSC) n/a
Depositing User:	Symplectic Sheffield
Date Deposited:	10 Aug 2022 12:50
Last Modified:	10 Aug 2022 12:50
Status:	Published
Publisher:	Springer Nature
Refereed:	Yes
Identification Number:	10.1186/s12916-022-02445-7
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:189879

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

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