Common scale minimal sufficient balance: An improved method for covariate-adaptive randomization based on the Wilcoxon-Mann-Whitney odds ratio statistic

Stat Med. 2022 May 10;41(10):1846-1861. doi: 10.1002/sim.9332. Epub 2022 Feb 17.

Abstract

Minimal sufficient balance (MSB) is a recently suggested method for adaptively controlling covariate imbalance in randomized controlled trials in a manner which reduces the impact on randomness of allocation over other approaches by only intervening when the imbalance is sufficiently significant. Despite its improvements, the approach is unable to consider the relative clinical importance or magnitude of imbalance in each covariate weight, and ignores any imbalance which is not statistically significant, even when these imbalances may collectively justify intervention. We propose the common scale MSB (CS-MSB) method which addresses these limitations, and present simulation studies comparing our proposed method to MSB. We demonstrate that CS-MSB requires less intervention than MSB to achieve the same level of covariate balance, and does not adversely impact either statistical power or Type-I error.

Keywords: adaptive randomization; allocation randomness; baseline covariate imbalance; clinical trial; minimal sufficient balance.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Computer Simulation
  • Humans
  • Odds Ratio
  • Random Allocation
  • Research Design*