Keywords: Adaptive dose finding simulation
The main objectives of a dose finding trial is the dose for confirmatory studies and exploration of the dose response curves. They are more efficient if they can allow for some adaptations according to accumulated data. These could be curtailment for either futility or strong efficacy, or could be an adaptation to learn more about the shape of the dose response curve. Whenever an adaptive dose finding trial is planned, simulations are needed to understand the operating characteristics under different scenarios.
This talk will look at planning, conducting and reporting simulations. It will focus on the practical aspects and will build on work carried out by the DIA Adaptive Design Scientific Working Group. Examples will be used to illustrate some best practices with regard to simulations. The talk will also offer advice as to how to avoid pitfalls and lead to more optimal dose finding.