Publications & White Papers

Archive for October, 2004

Adaptive Model-Based Designs for Dose-Finding Studies

October 1st, 2004

Adaptive Model-Based Designs for Dose-Finding Studies

Vladimir Dragalin and Valerii Fedorov

Abstract: We propose a new adaptive procedure for dose-finding in clinical trials when both efficacy and toxicity responses are available. We model the distribution of this bivariate binary endpoint using either Gumbel bivariate logistic regression or Cox bivariate binary model. In both cases, the analytic formulae for the Fisher information matrix are obtained, that form the basis for derivation of the locally optimal and adaptive designs.