Renata Tsirpitzi: Optimal dose-finding for efficacy-safety-model
Time: Wed 2019-03-06 13.00 - 14.00
Location: Room B705, Department of Statistics, Stockholm University
Lecturer: Renata Tsirpitzi, Department of Statistics
Abstract: Dose finding is an important part in clinical development of a new drug. The purpose of dose-finding studies is to determine a good dose for future development based on both efficacy and safety. Optimal experimental designs have already been used to determine the design for such kind of studies, however often it is focused on efficacy only. We will consider an efficacy-safety model which is a simplified version of the bivariate Emax model. We will use here the Clinical Utility Index (CUI) concept in order to give us the desirable balance between efficacy and safety. The dose that will maximize the utility of the patient should be estimated as well as possible in the dose-finding study. This desire will lead us to locally c-optimal designs. By replacing the dose with the logarithm of dose in the bivariate model, an algebraic solution for c-optimal designs has been determined for arbitrary c vectors.