Late Phase Design


Adaptive Trials White Papers

Our ICON Insights will help you understand and successfully address the complexities of adaptive trial design and execution.

Late phase design applies to the ‘confirm’ phase of development i.e. phase III pivotal trials. Regulatory agencies are more cautious about permitting a large number of adaptations in the confirm phase of development and thus only a limited number of potential design changes are permitted (e.g. futility stopping, population enrichment, sample size re-estimation). The key to success in pivotal studies is to ensure that information generated in the ‘learn’ phase is fully optimized. Only then will the high attrition rate in phase III be reduced.

Design & Simulation Software
For late phase study design, ICON offers ADDPLAN® software, in the following modules:

  • ADDPLAN BASE - the comprehensive toolbox for the design, simulation, and analysis for one or two sample clinical trials.
  • ADDPLAN MC – this module builds upon the features in ADDPLAN BASE and allows for the simulation and analysis of multi-armed clinical trials.
  • ADDPLAN PE – this module builds upon the features in ADDPLAN BASE and allows for the simulation and analysis of patient enrichment designs.