Bayesian designs for phase I-II clinical trials - 92

Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials.

At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. 'Bayesian Designs for Phase I-II Clinical Trials' describes how phase I-II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials.

It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes.