ArticleBMC medicine2021
Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project.
Article in BMC medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Characteristics, Progression, and Output of Randomized Platform Trials: A Systematic Review.JAMA network open · 2024Pooled it
- A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies.Wellcome open research · 2023Pooled it
- Adaptive trials in low back pain and osteoarthritis: How common are they and when should they be used? A systematic review from ClinicalTrials.gov.Osteoarthritis and cartilage open · 2026Review
- Article
- Clinical Trial Simulation: Planning With the OCTAVE Framework, Implementation and Validation Principles.Statistics in medicine · 2026Article
- Adaptive designs for trials aiming to optimise implementation strategies and the effect of an additional interim analysis: a simulation study.BMC medical research methodology · 2025Article
- Practical guidance for conducting high-quality and rapid interim analyses in adaptive clinical trials.BMC medicine · 2025Review
- Response adaptive randomisation in clinical trials: Current practice, gaps and future directions.Statistical methods in medical research · 2025Article
- Cost analysis of the TB-PRACTECAL clinical trial on novel tuberculosis treatment regimens.PLOS global public health · 2025Article
- Adaptive Trials in Stroke: Current Use and Future Directions.Neurology · 2024Review
- Reporting and communication of sample size calculations in adaptive clinical trials: a review of trial protocols and grant applications.BMC medical research methodology · 2024Review
- The performance of a Bayesian value-based sequential clinical trial design in the presence of an equivocal cost-effectiveness signal: evidence from the HERO trial.BMC medical research methodology · 2024Article
- Article
- Practical guidance for planning resources required to support publicly-funded adaptive clinical trials.BMC medicine · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors.
Funding
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.