Home > Research > Publications & Outputs > Practical guidance for planning resources requi...

Links

Text available via DOI:

View graph of relations

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

Research output: Contribution to Journal/MagazineJournal articlepeer-review

Published

Standard

Practical guidance for planning resources required to support publicly-funded adaptive clinical trials. / Wason, James M. S.; Dimairo, Munyaradzi; Biggs, Katie et al.
In: BMC Medicine, Vol. 20, No. 1, 254, 10.08.2022.

Research output: Contribution to Journal/MagazineJournal articlepeer-review

Harvard

Wason, JMS, Dimairo, M, Biggs, K, Bowden, S, Brown, J, Flight, L, Hall, J, Jaki, T, Lowe, R, Pallmann, P, Pilling, MA, Snowdon, C, Sydes, MR, Villar, SS, Weir, CJ, Wilson, N, Yap, C, Hancock, H & Maier, R 2022, 'Practical guidance for planning resources required to support publicly-funded adaptive clinical trials', BMC Medicine, vol. 20, no. 1, 254. https://doi.org/10.1186/s12916-022-02445-7

APA

Wason, J. M. S., Dimairo, M., Biggs, K., Bowden, S., Brown, J., Flight, L., Hall, J., 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. (2022). Practical guidance for planning resources required to support publicly-funded adaptive clinical trials. BMC Medicine, 20(1), Article 254. https://doi.org/10.1186/s12916-022-02445-7

Vancouver

Wason JMS, Dimairo M, Biggs K, Bowden S, Brown J, Flight L et al. Practical guidance for planning resources required to support publicly-funded adaptive clinical trials. BMC Medicine. 2022 Aug 10;20(1):254. doi: 10.1186/s12916-022-02445-7

Author

Wason, James M. S. ; Dimairo, Munyaradzi ; Biggs, Katie et al. / Practical guidance for planning resources required to support publicly-funded adaptive clinical trials. In: BMC Medicine. 2022 ; Vol. 20, No. 1.

Bibtex

@article{f5cf602ce4d6478ca57e296d13f1598a,
title = "Practical guidance for planning resources required to support publicly-funded adaptive clinical trials",
abstract = "AbstractAdaptive 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.",
keywords = "General Medicine",
author = "Wason, {James M. S.} and Munyaradzi Dimairo and Katie Biggs and Sarah Bowden and Julia Brown and Laura Flight and Jamie Hall and Thomas Jaki and Rachel Lowe 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 Nina Wilson and Christina Yap and Helen Hancock and Rebecca Maier",
year = "2022",
month = aug,
day = "10",
doi = "10.1186/s12916-022-02445-7",
language = "English",
volume = "20",
journal = "BMC Medicine",
issn = "1741-7015",
publisher = "BIOMED CENTRAL LTD",
number = "1",

}

RIS

TY - JOUR

T1 - Practical guidance for planning resources required to support publicly-funded adaptive clinical trials

AU - Wason, James M. S.

AU - Dimairo, Munyaradzi

AU - Biggs, Katie

AU - Bowden, Sarah

AU - Brown, Julia

AU - Flight, Laura

AU - Hall, Jamie

AU - Jaki, Thomas

AU - Lowe, Rachel

AU - Pallmann, Philip

AU - Pilling, Mark A.

AU - Snowdon, Claire

AU - Sydes, Matthew R.

AU - Villar, Sofía S.

AU - Weir, Christopher J.

AU - Wilson, Nina

AU - Yap, Christina

AU - Hancock, Helen

AU - Maier, Rebecca

PY - 2022/8/10

Y1 - 2022/8/10

N2 - AbstractAdaptive 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.

AB - AbstractAdaptive 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.

KW - General Medicine

U2 - 10.1186/s12916-022-02445-7

DO - 10.1186/s12916-022-02445-7

M3 - Journal article

VL - 20

JO - BMC Medicine

JF - BMC Medicine

SN - 1741-7015

IS - 1

M1 - 254

ER -