Utility-Based Dose Selection for Phase II Dose-Finding Studies.
Jihane AouniJean Noel BacroGwladys ToulemondePierre ColinLoic DarchyPublished in: Therapeutic innovation & regulatory science (2021)
Simulation results illustrate the difficulty of simultaneously estimating two complex dose-response models with enough accuracy to properly rank doses using an utility function combining the two. The probability of making the good decision increases with the sample size. For some scenarios, the sequential design has good properties: with a quite large probability of study termination at interim analysis, it enables to reduce the sample size while maintaining the properties of the fixed design.