ADDPLAN MC


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Operationally and inferentially seamless designs may significantly decrease development duration, while maintaining statistical validity. ADDPLAN® MC provides simulation and analysis functionality for multi-armed confirmatory studies and the inverse normal and Fisher’s p-value combination testing strategies. Different treatment selection rules may simply be examined for different response scenarios and development strategies to select the best design for regulatory approval. 

ADDPLAN® MC was the first validated adaptive multi-armed study design software.

Simulate Design: Simulation of inferentially & operationally seamless Phase II/III designs

  1. Control of family-wise error rate
  2. Early success/futility stopping

Sample size re-estimation based on conditional power
Adaptive treatment arm selection
Wide range of treatment arm selection rules
Sample size re-estimation
Simulation settings allowing easy power examination for different dose-response profiles
Simulation of treatment selection based on surrogate endpoints for survival data
ADDPLAN® MC manual provides insight into the applied methodology and worked examples

Adaptive Analysis: Interim & final analysis of adaptive multi armed study designs including...

Flexible dropping of treatment arms
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.

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