The asymptotic maximal procedure for subject randomization in clinical trials.

Abstract:

: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.

journal_name

Stat Methods Med Res

authors

Zhao W,Berger VW,Yu Z

doi

10.1177/0962280216677107

subject

Has Abstract

pub_date

2018-07-01 00:00:00

pages

2142-2153

issue

7

eissn

0962-2802

issn

1477-0334

pii

0962280216677107

journal_volume

27

pub_type

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