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Multi-arm multi-stage trials can improve the efficiency of finding effective treatments for stroke: a case study
Thomas Jaki1, James M S Wason2,3
1Department of Mathematics and Statistics, Lancaster University, Bailrigg, UK.
Background:
Many recent Stroke trials fail to show a beneficial effect of the intervention late in the development. Currently a large number of new treatment options are being developed. Multi-arm multi-stage (MAMS) designs offer one potential strategy to avoid lengthy studies of treatments without beneficial effects while at the same time allowing evaluation of several novel treatments. In this paper we provide a review of what MAMS designs are and argue that they are of particular value for Stroke trials. We illustrate this benefit through a case study based on previous published trials of endovascular treatment for acute ischemic stroke. We show in this case study that MAMS trials provide additional power for the same sample size compared to alternative trial designs. This level of additional power depends on the recruitment length of the trial, with most efficiency gained when recruitment is relatively slow. We conclude with a discussion of additional considerations required when starting a MAMS trial.
Conclusion:
MAMS trial designs are potentially very useful for stroke trials due to their improved statistical power compared to the traditional approach.
Insights
Multi-arm multi-stage (MAMS) designs offer an efficient approach for stroke clinical trials. These designs increase statistical power, reducing the need for lengthy studies of ineffective treatments.
Area of Science:
- Neurology
- Clinical Trials
- Biostatistics
Background:
- Many stroke trials face challenges with late-stage failures of interventions.
- A growing number of novel stroke treatments are under development.
- Traditional trial designs can be lengthy and inefficient for evaluating multiple treatments.
Purpose of the Study:
- To review Multi-Arm Multi-Stage (MAMS) designs.
- To advocate for the use of MAMS designs in stroke trials.
- To demonstrate the statistical advantages of MAMS designs through a case study.
Main Methods:
- Review of MAMS design principles.
- Case study analysis of endovascular treatment trials for acute ischemic stroke.
- Comparative power analysis against traditional trial designs.
Main Results:
- MAMS designs offer enhanced statistical power for stroke trials.
- Increased power is achieved with the same sample size compared to traditional designs.
- Efficiency gains are most significant in trials with slower recruitment rates.
Conclusions:
- MAMS designs are highly valuable for stroke clinical trials.
- These designs improve statistical power, making trials more efficient.
- Considerations for implementing MAMS trials are discussed.
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