Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project.
View / Open Files
Authors
Wilson, Nina
Biggs, Katie
Bowden, Sarah
Brown, Julia
Dimairo, Munyaradzi
Flight, Laura
Hall, Jamie
Hockaday, Anna
Lowe, Rachel
Murphy, Caroline
Pallmann, Philip
Snowdon, Claire
Sydes, Matthew R
Villar, Sofía S
Weir, Christopher J
Welburn, Jessica
Yap, Christina
Maier, Rebecca
Hancock, Helen
Publication Date
2021-10-26Journal Title
BMC Med
ISSN
1741-7015
Publisher
Springer Science and Business Media LLC
Volume
19
Issue
1
Pages
251
Language
eng
Type
Article
This Version
VoR
Metadata
Show full item recordCitation
Wilson, N., Biggs, K., Bowden, S., Brown, J., Dimairo, M., Flight, L., Hall, J., et al. (2021). Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project.. BMC Med, 19 (1), 251. https://doi.org/10.1186/s12916-021-02124-z
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 explore reasons for similarities and differences. RESULTS: Estimated resources associated with conducting an adaptive trial were always (moderately) higher than for the non-adaptive equivalent. The median increase was between 2 and 4% for all scenarios, except for sample size re-estimation which was 26.5% (as the adaptive design could lead to a lengthened study period). The highest increase was for statistical staff, with lower increases for data management and trial management staff. The percentage increase in resources varied across different CTUs. The interviews identified possible explanations for differences, including (1) experience in adaptive trials, (2) the complexity of the non-adaptive and adaptive design, and (3) the extent of non-trial specific core infrastructure funding the CTU had. CONCLUSIONS: This work sheds light on additional resources required to adequately support a high-quality adaptive trial. The percentage increase in costs for supporting an adaptive trial was generally modest and should not be a barrier to adaptive designs being cost-effective to use in practice. Informed by the results of this research, guidance for investigators and funders will be developed on appropriately resourcing adaptive trials.
Keywords
Adaptive clinical trials, Adaptive designs, Clinical trials, Efficiency, Resource requirements, Trial coordination, Cost-Benefit Analysis, Humans, Research Design, Research Personnel, Workforce
Sponsorship
NIHR Academy (NIHRDH-SRF-2015-08-001)
Identifiers
External DOI: https://doi.org/10.1186/s12916-021-02124-z
This record's URL: https://www.repository.cam.ac.uk/handle/1810/330252
Statistics
Total file downloads (since January 2020). For more information on metrics see the
IRUS guide.
Recommended or similar items
The current recommendation prototype on the Apollo Repository will be turned off on 03 February 2023. Although the pilot has been fruitful for both parties, the service provider IKVA is focusing on horizon scanning products and so the recommender service can no longer be supported. We recognise the importance of recommender services in supporting research discovery and are evaluating offerings from other service providers. If you would like to offer feedback on this decision please contact us on: support@repository.cam.ac.uk