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Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project

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Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project. / Wilson, Nina; Biggs, Katie; Bowden, Sarah et al.
In: BMC Medicine, Vol. 19, No. 1, 251, 26.10.2021.

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Harvard

Wilson, N, Biggs, K, Bowden, S, Brown, J, Dimairo, M, Flight, L, Hall, J, Hockaday, A, Jaki, T, Lowe, R, Murphy, C, Pallmann, P, Pilling, MA, Snowdon, C, Sydes, MR, Villar, SS, Weir, CJ, Welburn, J, Yap, C, Maier, R, Hancock, H & Wason, JMS 2021, 'Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project', BMC Medicine, vol. 19, no. 1, 251. https://doi.org/10.1186/s12916-021-02124-z

APA

Wilson, N., Biggs, K., Bowden, S., Brown, J., Dimairo, M., Flight, L., Hall, J., Hockaday, A., Jaki, T., Lowe, R., Murphy, C., Pallmann, P., Pilling, M. A., Snowdon, C., Sydes, M. R., Villar, S. S., Weir, C. J., Welburn, J., Yap, C., ... Wason, J. M. S. (2021). Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project. BMC Medicine, 19(1), Article 251. https://doi.org/10.1186/s12916-021-02124-z

Vancouver

Wilson N, Biggs K, Bowden S, Brown J, Dimairo M, Flight L et al. Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project. BMC Medicine. 2021 Oct 26;19(1):251. doi: 10.1186/s12916-021-02124-z

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Bibtex

@article{e86ebfd4340348e1b4cdcfca3b31dade,
title = "Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project",
abstract = "BackgroundAdaptive 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.MethodsWe 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.ResultsEstimated 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.ConclusionsThis 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 = "Efficiency, Clinical Trials, Adaptive Designs, Adaptive Clinical Trials, Resource Requirements, Trial Coordination",
author = "Nina Wilson and Katie Biggs and Sarah Bowden and Julia Brown and Munyaradzi Dimairo and Laura Flight and Jamie Hall and Anna Hockaday and Thomas Jaki and Rachel Lowe and Caroline Murphy and Philip Pallmann and Pilling, {Mark A} and Claire Snowdon and Sydes, {Matthew R} and Villar, {Sof{\'i}a S} and Weir, {Christopher J} and Jessica Welburn and Christina Yap and Rebecca Maier and Helen Hancock and Wason, {James M S}",
year = "2021",
month = oct,
day = "26",
doi = "10.1186/s12916-021-02124-z",
language = "English",
volume = "19",
journal = "BMC Medicine",
issn = "1741-7015",
publisher = "BIOMED CENTRAL LTD",
number = "1",

}

RIS

TY - JOUR

T1 - Costs and staffing resource requirements for adaptive clinical trials

T2 - quantitative and qualitative results from the Costing Adaptive Trials project

AU - Wilson, Nina

AU - Biggs, Katie

AU - Bowden, Sarah

AU - Brown, Julia

AU - Dimairo, Munyaradzi

AU - Flight, Laura

AU - Hall, Jamie

AU - Hockaday, Anna

AU - Jaki, Thomas

AU - Lowe, Rachel

AU - Murphy, Caroline

AU - Pallmann, Philip

AU - Pilling, Mark A

AU - Snowdon, Claire

AU - Sydes, Matthew R

AU - Villar, Sofía S

AU - Weir, Christopher J

AU - Welburn, Jessica

AU - Yap, Christina

AU - Maier, Rebecca

AU - Hancock, Helen

AU - Wason, James M S

PY - 2021/10/26

Y1 - 2021/10/26

N2 - BackgroundAdaptive 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.MethodsWe 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.ResultsEstimated 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.ConclusionsThis 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.

AB - BackgroundAdaptive 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.MethodsWe 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.ResultsEstimated 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.ConclusionsThis 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.

KW - Efficiency

KW - Clinical Trials

KW - Adaptive Designs

KW - Adaptive Clinical Trials

KW - Resource Requirements

KW - Trial Coordination

U2 - 10.1186/s12916-021-02124-z

DO - 10.1186/s12916-021-02124-z

M3 - Journal article

VL - 19

JO - BMC Medicine

JF - BMC Medicine

SN - 1741-7015

IS - 1

M1 - 251

ER -