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Keywords:

  • Adaptive design;
  • Dose finding;
  • Dose–response model;
  • Optimal design;
  • Sigmoid Emax model;
  • Target dose estimation

Abstract

We introduce a new optimal design for dose finding with a continuous efficacy endpoint. This design is studied in the context of a flexible model for the mean of the dose–response. The design incorporates aspects of both D- and c-optimality and can be used when the study goals under consideration include dose–response estimation, followed by identification of the target dose. Different optimality criteria are considered. Simulations are shown with results comparing our adaptive design to the fixed allocation (without adaptations). We show that both the estimation of dose–response and identification of the minimum effective dose are improved using our design.