Design and Analysis of Clinical Trials for Predictive Medicine

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An emerging clinical trials paradigm for predictive medicine involves the development of molecular diagnostics to enable the prediction of the effects of treatment or outcomes of individual patients. This book offers statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics. The book explains how to identify molecular biomarkers using DNA microarrays, validate the developed biomarkers, and confirm their clinical utility in randomized clinical trials.