Bayesian Designs for Phase I-II Clinical Trials

<p>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. </p><p><strong>Bayesian Designs for Phase I–II Clinical Trials</strong> 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.</p><p>Written by research leaders from the University of Texas MD Anderson Cancer Center this book shows how Bayesian designs for early-phase clinical trials can explore refine and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity. </p>