ADDPLAN PE

ADDPLAN® PE provides simulation and analysis functionality for adaptive enrichment designs including population selection, sample size re-estimation and early stopping for efficacy or futility using adaptive group sequential design approaches.

The inverse normal and Fisher’s p-value combination testing strategies, several multiple testing procedures and many alternative subpopulation(s) selection rules may be used for the evaluation of study design options.

• Calculation of operating characteristics for studies including multiple populations
• Control of family-wise error rate
• Early success/futility stopping
• Sample size re-estimation based on conditional power
• Wide range of subgroup (population) selection rules
• Simulation settings allowing easy power examination for prevalence and efficacy scenarios
• Simulation of population selection based on surrogate endpoints for survival data ADDPLAN® PE manual provides insight into the applied methodology and worked examples
• Simulation of treatment selection based on surrogate endpoints for survival data

• Interim & final analysis of adaptive population enrichment study designs including:
• Flexible dropping of populations
• Sample size re-estimation based on observed or assumed effects
• Conditional power calculation based on the remaining total sample size
• Repeated confidence intervals taking possible early stopping into account.