Bayesian adaptive D-optimal design with delayed responses

In some disease areas such as diabetes and obesity, patients may need to be studied for several weeks or months for a drug effect to emerge, where longitudinal data are normally collected for each patient. These delayed responses provide challenges to current adaptive design methods. Fu and Manner ( 2010 ) provided an integrated two-component prediction (ITP) model for delayed response adaptive design. In this paper, we extend their ITP model to incorporate a dose-response model in it and propose an ITP Emax model. Furthermore, we propose a utility function for decision making and this utility function is based on D-optimal design theory. We demonstrate our method by a simulation study, and potential sample size reduction is also discussed.