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The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly targeted treatment. At the same time, pretreatment prediction of patients’ clinical outcomes and responsiveness to treatment based on reliable molecular biomarkers or diagnostic tests is becoming an essential component of modern medicine. Confronted with such a major break in the evolution toward personalized or predictive medicine, the methodologies for design and analysis of clinical trials also have to evolve.
This book is one of the first attempts to provide a systematic coverage of all stages of clinical trials for the codevelopment of therapeutics and diagnostics for predictive medicine. Chapter 1 provides a detailed listing of the contents of this book. The target audience includes researchers, practitioners, and students of clinical biostatistics. Many chapters may also be beneficial for clinical investigators, translational scientists, and others who are involved in clinical trials.
As the new paradigm toward predictive medicine continues to evolve, we hope that this book will contribute to its development through the use of appropriate statistical designs and methods in future clinical trials. We also hope the book will stimulate active statistical research in this area. We sincerely express our thanks to all of the contributors to this book, who are leading experts in academia, the pharmaceutical industry, or government organizations for providing an overview of the current state of the art in this area.
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