ADDPLAN Base


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ADDPLAN® BASE is a comprehensive set of tools for confirmatory adaptive study designs. Its functionalities cover all aspects from the design to the analysis stage of an adaptive confirmatory trial. 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: 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 &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.

 

Screenshots

     

Design Your Trial

All Relevant Group Sequential Designs

     

Compare Your Effect Size

Ready-to-Use Text Modules

     

Visualize Your Decision Boundaries

Simulate Your Trial Design

     

Compare Test Strategies

Assess Survival Assumptions

     

Dose-Response Shape

Assess Treatment Arm Selection Rules

     

Produce Your Own Charts and Tables

Analyze Your Data

     

Seamless Phase II/III Combinations

Enrichment Designs

     

Visualize Your Trial's Progress

Recalculate the Sample Size

     

Demonstrate the Conditional Power

Redesign Your Trial

  

Audit Trial Information