A comprehensive set of tools for confirmatory adaptive study designs, covering all aspects from design to analysis

The design functionality delivers stopping boundaries and associated sample sizes for a range of potential designs and data types, and the impact of sample size reassessment strategies can be assessed using the simulation functionality.

The analysis functionality supports decision making in the actual execution of the trial. The ADDPLAN® BASE manual provides a comprehensive overview on the implemented methodology.

ADDPLAN® BASE was the first validated adaptive group sequential design software including:

  • Study types: Superiority, Non-inferiority and Equivalence testing
  • Endpoints: Means, Rates and Survival Group Sequential Designs which are all frequently used group sequential decision boundaries, from α- (and β-) spending functions to Wang&Tsiatis optimal designs:
  • Early stopping for efficacy
  • Binding and non-binding stopping for futility

Plan new design

  • Sample size and power calculations for group sequential designs
  • General design: Comparison of  the sample size of fixed and group sequential designs
  • Sample size and power calculations for tests of means, rates and survival analysis

Simulate design

  • Calculation of operating characteristics for adaptive group sequential designs
  • Sample size re-estimation is possible at any stage based on conditional power for:
  • Overall study success or next stage success
  • Considering the interim effect estimator or originally assumed effects
  • Implemented methodology is statistically valid:
  • Control of false positive rate guaranteed
  • Higher flexibility in sample size re-estimation as compared to other approaches (e.g. promising zone approach)

Adaptive analysis

  • Interim and final analysis of adaptive study designs including:
  • Decision recommendations (Early stopping)
  • 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
  • Re-planning the remainder of the trial using the recursive testing strategy approach