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.

Simulate design

  • 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

Adaptive analysis

  • 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.