Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practiceand problems

Clinical trial investigators often record a great deal of baseline data on each patient at randomization. When reporting the trial's findings such baseline data can be used for (i) subgroup analyses which explore whether there is evidence that the treatment difference depends on certain patient characteristics, (ii) covariate-adjusted analyses which aim to refine the analysis of the overall treatment difference by taking account of the fact that some baseline characteristics are related to outcome and may be unbalanced between treatment groups, and (iii) baseline comparisons which compare the baseline characteristics of patients in each treatment group for any possible (unlucky) differences. This paper…