Imbalanced randomization in clinical trials

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

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/.

Keywords: efficiency; noninferiority trial; randomization.

MeSH terms

  • Bias
  • Humans
  • Random Allocation*