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Minimize the use of minimization with unequal allocation
Authors:Proschan Michael  Brittain Erica  Kammerman Lisa
Affiliation:Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700A Rockledge Drive, Room 5140, Bethesda, Maryland 20892-7609, USA. ProschaM@niaid.nih.gov
Abstract:Summary Minimization as an alternative to randomization is gaining popularity for small clinical trials. In response to critics’ questions about the proper analysis of such a trial, proponents have argued that a rerandomization approach, akin to a permutation test with conventional randomization, can be used. However, they add that this computationally intensive approach is not necessary because its results are very similar to those of a t ‐test or test of proportions unless the sample size is very small. We show that minimization applied with unequal allocation causes problems that challenge this conventional wisdom.
Keywords:Adaptive randomization  Analyze as you randomize  Asymptotics  Minimization  Permuted block randomization  Permutation test  Randomization  Rerandomization test  Temporal trend  Unequal allocation
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