Comparison of two ethnic populations using distribution adjusted mean

J Biopharm Stat. 2013 May;23(3):539-58. doi: 10.1080/10543406.2012.755997.

Abstract

In similarly designed clinical trials conducted in different regions or a multiregional trial, we sometimes observe different mean responses between trials or regions due to differences in distributions of an ethnic factor. Uesaka et al. ( 2003 ) used adjusted means for covariate, the distribution adjusted mean, to deal with such a situation. This paper examines distributional properties of the distribution adjusted mean and shows its applicability to comparison of mean responses from clinical trials where the distribution of an ethnic factor is different between regions. A real example and simulation results are shown. The results of this paper enable us to evaluate the similarity of different responses in clinical trials from different ethnic populations.

Publication types

  • Comparative Study

MeSH terms

  • Algorithms
  • Analysis of Variance
  • Bone Density
  • Computer Simulation
  • Cross-Cultural Comparison*
  • Data Interpretation, Statistical*
  • Ethnicity / statistics & numerical data*
  • Fractures, Bone / drug therapy
  • Humans
  • Japan
  • Monte Carlo Method
  • Raloxifene Hydrochloride / therapeutic use
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • Sample Size
  • Selective Estrogen Receptor Modulators / therapeutic use
  • Treatment Outcome

Substances

  • Selective Estrogen Receptor Modulators
  • Raloxifene Hydrochloride