ADDPLAN

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Clinical Trials Software

The ADDPLAN Software

ADDPLAN Adaptive Designs – Plans and Analyses was first released in 2002 and is designed for the purpose of planning and conducting all phases of clinical trials, with an emphasis on adaptive group sequential test designs. This professionally validated, 21 CFR Part 11 compliant software, also allows the simulation of specific adaptation rules. Additionally, it combines the key features of planning and conducting a sequentially planned clinical trial within a user-friendly interface.

With release 6, ADDPLAN is the first software package that incorporates a majority of the requirements brought forward in the FDA “Draft Guidance on Adaptive Design for Clinical Trials for Drugs and Biologics”.  Examples of this requirements include:  multiple comparison procedures for multi-armed adaptive trials, including treatment selection designs, flexible combination of clinical research phases, and patient enrichment designs.

What’s New in ADDPLAN 6?

  • ADDPLAN 6 is available in three modules:
    • BASE (for one- and two-sample studies)
    • MC (multiple comparisons in multi-armed studies)
    • PE (patient enrichment designs)
  • β-spending function approach
  • Extended simulation features for survival designs
    • Weibull survival distribution
    • Piecewise accrual
    • Assumptions on drop-out rates
    • Multi-armed designs
  • Simulation and analysis of patient enrichment designs