Discussion of "The White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Designs".

The author reports on the discussion of the white paper on adaptive dose-ranging designs by the Phrma working Group in Great Britain. He states that the discussion is focusing on methodological issues and drug development. He stresses out that the white paper conducts simulations to compare a traditional approach with alternative design-focused and analysis-focused approaches. He also discusses the different level of phases on the pre-clinical trials.