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Minimal sufficient balance randomization for sequential randomized controlled trial designs: results from the ESCAPE
Tolulope T Sajobi1,2,3,4, Gurbakhshash Singh1, Mark W Lowerison1,3
1Department of Community Health Sciences and O'Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Trials
|November 4, 2017
Summary
The ESCAPE trial successfully used minimal sufficient balance randomization, a covariate-adaptive technique, to ensure balanced groups in a stroke study. This method proved effective for small clinical trials and data monitoring.
Area of Science:
- Neurology
- Clinical Trials
- Biostatistics
Background:
- The Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times (ESCAPE) trial investigated endovascular treatment for stroke.
- Implementing efficient randomization is crucial for the integrity of clinical trials, especially those with smaller sample sizes.
Purpose of the Study:
- To describe the implementation and effectiveness of minimal sufficient balance randomization in the ESCAPE trial.
- To demonstrate the feasibility of covariate-adaptive randomization for balancing baseline characteristics in clinical research.
Main Methods:
- The ESCAPE trial utilized a prospective, multicenter, randomized clinical trial design.
- A real-time, dynamic, Internet-based minimal sufficient balance randomization method was employed.
- This method balanced study arms based on key baseline covariates: age, sex, NIHSS score, arterial occlusion site, ASPECTS score, and alteplase treatment.
Main Results:
- Permutation tests confirmed successful group balance across all tested baseline covariates.
- Key balanced covariates included sex (p=1.00), NIHSS score (p=0.95), arterial occlusion site (p=1.00), ASPECTS score (p=0.28), alteplase treatment (p=0.31), and age (p=0.67).
Conclusions:
- Minimal sufficient balance randomization is a feasible and beneficial technique for small-sample clinical trials.
- This covariate-adaptive randomization scheme supports effective data monitoring in clinical research.
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