Practical guidance for planning resources required to support publicly-funded adaptive clinical trials.
Date
2022-08-10Author
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
Type
Journal Article
Metadata
Show full item recordAbstract
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.
Collections
Subject
Adaptive clinical trials
Adaptive designs
Clinical trials
Efficiency
Resource requirements
Trial coordination
Humans
Research Design
Research team
Clin Trials & Stats Unit
Language
eng
Date accepted
2022-06-20
License start date
2022-08-10
Citation
BMC Medicine, 2022, 20 (1), pp. 254 -
Publisher
BMC