Lachin J M, Matts J P, Wei L J
George Washington University, Department of Statistics/Computer and Information Systems, Rockville, Maryland 20852.
Control Clin Trials. 1988 Dec;9(4):365-74. doi: 10.1016/0197-2456(88)90049-9.
The statistical properties of simple (complete) randomization, permuted-block (or simply blocked) randomization, and the urn adaptive biased-coin randomization are summarized. These procedures are contrasted to covariate adaptive procedures such as minimization and to response adaptive procedures such as the play-the-winner rule. General recommendations are offered regarding the use of complete, permuted-block, or urn randomization. In a large double-masked trial, any of these procedures may be acceptable. For a given trial, the relative merits of each procedure should be carefully weighed in relation to the characteristics of the trial. Important considerations are the size of the trial, overall as well as within the smallest subgroup to be employed in a subgroup-specific analysis, whether or not the trial is to be masked, and the resources needed to perform the proper randomization-based permutational analysis.
总结了简单（完全）随机化、排列区组（或简称为区组）随机化以及瓮自适应偏倚硬币随机化的统计特性。将这些程序与协变量自适应程序（如最小化）和响应自适应程序（如胜者全得规则）进行了对比。针对完全随机化、排列区组随机化或瓮随机化的使用给出了一般性建议。在大型双盲试验中，这些程序中的任何一种都可能是可接受的。对于给定的试验，应根据试验的特征仔细权衡每种程序的相对优点。重要的考虑因素包括试验的规模，整体规模以及用于亚组特异性分析的最小亚组的规模，试验是否要设盲，以及进行基于适当随机化的排列分析所需的资源。
