ADDPLAN® MC

The ADDPLAN® MC module builds upon the features in the base module and allows for the simulation and analysis of multi-armed clinical trials (e.g. dose finding studies).



Simulation

For multi-armed designs, simulations are available for:

  • Comparison of flexible combination tests with separate phase II/III designs
  • Sample size reassessment procedures for multi-armed designs
  • Assessing the power and ASN of adaptive multi-armed designs
  • Assessing the bias of effect size estimates
  • Assessing the probability to select specific treatment arms
  • Assessing intersection tests: Dunnett, Bonferroni (Holm), Šidák, Simes (Hommel), hierarchical testing
  • Comparing treatment arm selection rules
  • Comparing dose-response shapes, e.g., linear, logistic, Emax, sigmoid Emax, exponential, etc.
  • Assessing different sample size allocation over treatment arms
  • Selecting treatment arm based on biomarkers or surrogate endpoints
Analysis

Specific options for performing an analysis of multi-armed designs include:

  • Confirmatory analysis for multi-armed trial with selection of treatment arms
  • Closed testing procedure
  • Choice of intersection tests: Dunnett, Bonferroni, Sidák, Simes, hierarchical testing
  • Sample size recalculation for multi-armed designs
  • Multiplicity adjusted confidence intervals for many to one comparisons
  • Overall multiplicity adjusted p-values
Screenshots


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