The first validated software for adaptive confirmatory studies with population enrichment
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.