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The following aspects can be considered by simulations for patient enrichment designs:

  • Influence of the unknown prevalence of the selection population on the power
  • Influence of different assumptions about treatment differences in S and Sc on the power
  • Influence on the population selection criteria on the power
  • Comparison of patient enrichment strategies as compared to other strategies (e.g., group sequential designs)
  • Robustness of the design with regard to the selection of the correct subpopulation at the first stage
  • Subpopulation selection based on biomarkers or surrogate endpoints

Specific options for performing patient enrichment designs include:

  • Confirmatory analysis for patient enrichment trials
  • Conditional power calculations for population selection and sample size reassessment
  • Multiplicity adjusted confidence intervals
  • Overall multiplicity adjusted p-values



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