title: Minimize the use of minimization with unequal allocation.
abstract: 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.
authors.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
authors.forename: Michael
authors.initials: M
authors.lastname: Proschan
authors.forename: Erica
authors.initials: E
authors.lastname: Brittain
authors.forename: Lisa
authors.initials: L
authors.lastname: Kammerman
mesh_terms: D001699:Biometry / Q000379:methods; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D006801:Humans; D015233:Models, Statistical; D011897:Random Allocation; D012107:Research Design / Q000706:statistics & numerical data*; D018401:Sample Size