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

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, Pilling, Mark A., Snowdon, Claire, Sydes, Matthew R., Villar, Sofía 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, p. 254.

Date of publication of this fulltext: 29 Sep 2025 06:43
Article
DOI to cite this document: 10.5283/epub.77854


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 ...

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.



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Details

Item typeArticle
Journal or Publication TitleBMC Medicine
Publisher:Springer Nature
Open Access Type:CC-License
Volume:20
Page Range:p. 254
Date10 August 2022
InstitutionsInformatics and Data Science > Department Machine Learning & Data Science > Lehrstuhl für Computational Statistics (Prof. Dr. Thomas Jaki)
Identification Number
ValueType
10.1186/s12916-022-02445-7DOI
KeywordsAdaptive designs Adaptive clinical trials Clinical trials Efficiency Resource requirements Trial coordination
Dewey Decimal Classification000 Computer science, information & general works > 004 Computer science
StatusPublished
RefereedYes, this version has been refereed
Created at the University of RegensburgNo
URN of the UB Regensburgurn:nbn:de:bvb:355-epub-778549
Item ID77854

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