Randomization tests in clinical trials with multiple imputation for handling missing data

J Biopharm Stat. 2022 May 4;32(3):441-449. doi: 10.1080/10543406.2022.2080695. Epub 2022 Jun 6.

Abstract

Randomization-based inference is a useful alternative to traditional population model-based methods. In trials with missing data, multiple imputation is often used. We describe how to construct a randomization test in clinical trials where multiple imputation is used for handling missing data. We illustrate the proposed methodology using Fisher's combining function applied to individual scores in two post-traumatic stress disorder trials.

Keywords: Analyze as you randomize; Fisher’s combination; minimization; multiple imputation; nonparametric combination of tests; randomization; re-randomization test.

MeSH terms

  • Data Interpretation, Statistical*
  • Humans
  • Random Allocation