Issues related to subgroup analysis in clinical trials

J Biopharm Stat. 2002 Aug;12(3):347-58. doi: 10.1081/bip-120014565.

Abstract

Interpretation of subgroup findings is a difficult task. The attempt of this article is to clarify confusions on subgroup analysis and to give some practical suggestions on how to avoid mistakes in interpreting subgroup outcome. We believe that the correct interpretation of subgroup findings is closely related to the intrinsic statistical property and validity of the subgroup analysis. A systematic discussion on subgroup analysis from a statistical point of view will be helpful to clinical trial practitioners.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Bias
  • Clinical Trials as Topic / statistics & numerical data*
  • Geography
  • Models, Statistical
  • Reproducibility of Results
  • Research Design / statistics & numerical data*