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The asymptotic maximal procedure for subject randomization in clinical trials
Wenle Zhao1, Vance W Berger2,3, Zhenning Yu1
11 Department of Public Health Sciences, Medical University of South Carolina, Charleston, USA.
The asymptotic maximal procedure simplifies restricted randomization in clinical trials by using approximate probabilities. This method is a practical alternative to the original maximal procedure for ensuring balanced treatment groups.
Area of Science:
- Biostatistics
- Clinical Trial Design
Background:
- Restricted randomization methods aim to balance treatment groups in clinical trials.
- The maximal procedure maximizes feasible allocation sequences but is difficult to implement due to non-Markovian properties.
Purpose of the Study:
- To propose a new randomization procedure, the asymptotic maximal procedure, simplifying implementation.
- To evaluate the performance of the asymptotic maximal procedure compared to existing methods.
Main Methods:
- Developed the asymptotic maximal procedure by replacing sequence-length-dependent probabilities with asymptotic values.
- Conducted simulations to compare the asymptotic maximal procedure with the original maximal procedure and other randomization techniques.
- Evaluated procedures based on maximum tolerated imbalance.
Main Results:
- The asymptotic maximal procedure demonstrated practical utility in simulations.
- The proposed method offers a viable alternative for implementing restricted randomization with maximum tolerated imbalance.
Conclusions:
- The asymptotic maximal procedure is a practical and implementable randomization method for clinical trials.
- This procedure addresses the implementation challenges of the original maximal procedure while maintaining balance.
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