ADDPLAN® PE

The ADDPLAN® PE module builds upon the features in the base module and allows for the simulation and analysis of patient enrichment designs.


Simulation

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

Analysis

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
Screenshots


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