Proschan Michael, Brittain Erica, Kammerman Lisa
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700A Rockledge Drive, Room 5140, Bethesda, Maryland 20892-7609, USA.
Biometrics. 2011 Sep;67(3):1135-41. doi: 10.1111/j.1541-0420.2010.01545.x. Epub 2011 Jan 31.
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.
作为随机化的替代方法，最小化法在小型临床试验中越来越受欢迎。针对批评者对这类试验正确分析方法的质疑，支持者认为可以采用一种重新随机化方法，类似于传统随机化的排列检验。然而，他们补充说，这种计算量很大的方法并非必要，因为除非样本量非常小，其结果与t检验或比例检验的结果非常相似。我们表明，采用不等分配的最小化法会引发一些问题，对这种传统观念构成挑战。
