Comparison of Phase I-II designs with parametric or semi-parametric models using two different risk-benefit trade-off criteria

A semi-parametric stochastic ordering model (SPSO) is introduced to characterize functional relationships between dose level and the probabilities of binary Efficacy and Toxicity events. This model is used to implement a Bayesian adaptive phase I-II clinical trial using one of two different optimality criteria, either dose desirability defined as a function of the marginal Efficacy and Toxicity probabilities, or mean utility based on numerical scores of the four possible (Efficacy, Toxicity) events.
Source: Contemporary Clinical Trials - Category: Radiology Authors: Source Type: research