Covariate imbalance and random allocation in clinical trials

S. J. Senn*

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

217 Citations (Scopus)

Abstract

A model is developed to estimate the effect of covariate imbalance on the size of a test of treatment efficacy in randomized clinical trials comparing two treatments when dispersion parameters are known. It is concluded that tests of homogeneity on the covariates should not be performed, that covariate imbalance is just as much a problem for large studies as for small ones in terms of effect on size, and that the effect of correlation between covariates and measures of efficacy is more complex than has previously been sugested. The best way to adjust for covariate imbalance is by an analysis of covariance.

Original languageEnglish
Pages (from-to)467-475
Number of pages9
JournalStatistics in Medicine
Volume8
Issue number4
DOIs
Publication statusPublished - Apr 1989
Externally publishedYes

Keywords

  • Analysis of covariance
  • Clinical trials
  • Covariate imbalance
  • Randomization
  • Size
  • Tests of homogeneity

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