The asymptotic maximal procedure for subject randomization in clinical trials

The maximal procedure is a restricted randomization method that maximizes the number of feasible allocation sequences under the constraints of the maximum tolerated imbalance and the allocation sequence length. It assigns an equal probability to all feasible sequences. However, its implementation is...

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Bibliographic Details
Published inStatistical methods in medical research Vol. 27; no. 7; p. 2142
Main Authors Zhao, Wenle, Berger, Vance W, Yu, Zhenning
Format Journal Article
LanguageEnglish
Published England 01.07.2018
Subjects
subject randomization
Allocation predictability
asymptotic maximal procedure
randomized controlled trial
treatment imbalance
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Summary:The maximal procedure is a restricted randomization method that maximizes the number of feasible allocation sequences under the constraints of the maximum tolerated imbalance and the allocation sequence length. It assigns an equal probability to all feasible sequences. However, its implementation is not easy due to the lack of the Markovian property of the conditional allocation probabilities. In this paper, we propose the asymptotic maximal procedure, which replaces the sequence-length-dependent conditional allocation probabilities with their asymptotic values. The new randomization procedure is compared with the original maximal procedure and few other randomization procedures with the maximum tolerated imbalance via simulations and is found to be a practical choice for future clinical trials.
ISSN:1477-0334
DOI:10.1177/0962280216677107