Historically, the selection of doses for Phase III confirmatory studies has often been poor due to a lack of understanding of the relationship between efficacy and dose.
For an informed Phase III dose selection it is essential that the full shape of the dose-response curve is characterized in Phase II trials. Traditional Phase II designs that use a fixed choice of doses and rely on comparisons between dose means can be poor at doing this. Using analysis methods that estimate the complete dose-response relationship and allow the choice of doses to change in an adaptive manner during a Phase II trial lead to more informative studies and ultimately better planning for Phase III.
In this course we will describe methods for dose-response modeling with some focus on the MCPMod methodology, in addition we discuss adaptive dose-finding designs and will describe the main features of the DoseFinding R package. This package implements the methods described in this tutorial and will be illustrated on several examples
2) Dose-Response Modelling
Application to example
4) Optimal designs / Adaptive design