临床试验中的不均衡随机化

Imbalanced randomization in clinical trials.

作者信息

Chandereng Thevaa, Wei Xiaodan, Chappell Rick

机构信息

Department of Statistics, University of Wisconsin-Madison, Wisconsin, USA.

Department of Biostatistics & Medical Informatics, University of Wisconsin-Madison, Wisconsin, USA.

出版信息

Stat Med. 2020 Jul 20;39(16):2185-2196. doi: 10.1002/sim.8539. Epub 2020 Apr 3.

DOI:10.1002/sim.8539

PMID:32246484

Abstract

Randomization is a common technique used in clinical trials to eliminate potential bias and confounders in a patient population. Equal allocation to treatment groups is the standard due to its optimal efficiency in many cases. However, in certain scenarios, unequal allocation can improve efficiency. In superiority trials with more than two groups, the optimal randomization is not always a balanced randomization. In noninferiority (NI) trials, additive margin with equal variance is the http://www.statlab.wisc.edu/shiny/SSNI/.

摘要

随机化是临床试验中常用的一种技术，用于消除患者群体中的潜在偏差和混杂因素。由于在许多情况下具有最佳效率，因此将患者平等分配到治疗组是标准做法。然而，在某些情况下，不平等分配可以提高效率。在有两个以上组的优效性试验中，最优随机化并不总是均衡随机化。在非劣效性（NI）试验中，具有等方差的相加界值是http://www.statlab.wisc.edu/shiny/SSNI/ 。