Adaptive optimal designs for dose-finding studies based on sigmoid Emax models

Abstract

The adaptive design strategy is a feasible approach for optimal designs in dose-finding studies, where the information matrices usually depend on the unknown parameters. Focusing on three pharmacodynamics sigmoid Emax models, we derive the corresponding simple formats of the adaptive optimal designs regardless of the optimality criteria or parameters of interest. An algorithm for deriving a specific adaptive optimal design is developed. A simulation study comparing the adaptive optimal designs and the uniform designs is also performed.