The ADDPLAN 6 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, e.g.,
- Comparison of flexible combination tests with separate phase II/III designs
- Sample size reassessment procedures for multi-armed designs
- Assess 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
Interactive 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
