Clinical and Statistical Considerations in Personalized Medicine

ISBN-13: 9780367378769 / Angielski / Miękka / 2019 / 376 str.

Claudio Carini; Sandeep M. Menon; Mark Chang

Opis

Despite the vast amount of literature on biomarkers, there is no comprehensive book that integrates the clinical and statistical components. This book is one of the first to incorporate both the clinical and statistical aspects of biomarkers in the personalized medicine paradigm. Leading clinicians, biostatisticians, regulators, commercial professionals, and researchers address the opportunities and challenges in successfully applying biomarkers in drug discovery and preclinical and clinical development. They cover a wide spectrum of personalized medicine-related topics, including epigenetics, adaptive designs, statistical methods, regulatory issues, and more.

Spis treści

Biomarkers for Drug Development: The Time Is Now! RNAi Screens: Triumphs and Tribulations. Current Advances in Epigenetics. Biomarkers and Precision Medicine: The Case of Rare Diseases. Biomarker-Informed Adaptive Design. Fitting the Dose: Adaptive Staggered Dose Design. Evidence-Based Adaptive Statistical Decision and Design Strategies for Maximizing the Efficiency of Clinical Oncology Development Programs with Predictive Biomarkers. Biomarker Identification in Clinical Trials. Multiplicity in Pharmacogenomics. Patient-Reported Outcomes in Personalized Medicine. Regulatory Issues in Use of Biomarkers in Drug Development. Index.

O autorze

Claudio Carini, Sandeep Menon, Mark Chang