Adaptive Dc-optimal designs for dose finding based on a continuous efficacy endpoint.
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.
Padmanabhan
S Krishna
SK
Wyeth Research, Collegeville, PA 19426, USA.
Dragalin
Vladimir
V
D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D055808:Drug Discovery; D023381:Endpoint Determination / Q000379:methods*; D006801:Humans; D015233:Models, Statistical