Full Description
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.
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.
Contents
Why Conduct Phase I-II Trials? The Phase I-II Paradigm. Establishing Priors. Efficacy-Toxicity Trade-Off-Based Designs. Designs with Late-Onset Outcomes. Utility-Based Designs. Personalized Dose Finding. Combination Trials. Optimizing Molecularly Targeted Agents. Optimizing Doses in Two Cycles. Optimizing Dose and Schedule. Dealing with Dropouts. Optimizing Intra-Arterial tPA. Optimizing Sedative Dose in Preterm Infants. Bibliography.
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