Chapter 11 Guidance on Applying Covariate Adjustment

11.1 Relevant Regulatory Guidance


11.2 Missing Covariates

  • How much missingness is too much
  • Approaches and justification for missing covariates
  • Preserving independence of covariates and treatment

11.3 Statistical Analysis Plans


11.4 Sample size for adjusted vs. unadjusted


11.5 Number of parameters vs. sample size

  • Adjusting for sites in multi-site trial

11.6 Data-Adaptive Covariate Adjustment