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Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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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 -