Richard Simon

Marc Buyse

Shigeyuki Matsui

Design and Analysis of Clinical Trials for Predictive Medicine provides 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-from identifying molecular biomarkers using DNA microarrays to confirming

Design and Analysis of Clinical Trials for Predictive Medicine

John Crowley

This book presents the state of the art of biostatistical methods and their applications in clinical oncology. Many methodologies established today in biostatistics have been brought about through its applications to the design and analysis of oncology clinical studies. This field of oncology, now in the midst of evolution owing to rapid advances in biotechnologies and cancer genomics, is becoming one of the most promising disease fields in the shift toward personalized medicine. Modern developments of diagnosis and therapeutics of cancer have also been continuously fueled by recent progress in establishing the infrastructure for conducting more complex, large-scale clinical trials and observational studies. The field of cancer clinical studies therefore will continue to provide many new statistical challenges that warrant further progress in the methodology and practice of biostatistics. This book provides a systematic coverage of various stages of cancer clinical studies. Topics from modern cancer clinical trials include phase I clinical trials for combination therapies, exploratory phase II trials with multiple endpoints/treatments, and confirmative biomarker-based phase III trials with interim monitoring and adaptation. It also covers important areas of cancer screening, prognostic analysis, and the analysis of large-scale molecular data in the era of big data.

Shigeyuki Matsui

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