Description
Book SynopsisThe Future of Clinical Research and Health Care: From Empirical to Precision Medicine
Clinical and Statistical Considerations in Personalized Medicine explores recent advances related to biomarkers and their translation into clinical development. 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.
Robust Biomarkers for Drug Development and Disease Treatment
The first four chapters discuss biomarker development from a clinical perspective. Coverage ranges from an introduction to biomarkers to advances in RNAi screens, epigenetics, and rare diseases as targets for personalized medicine approaches. Subsequent chapters examine the statistical considerations in applying a personalized medicine approach, including multiplicity in pharmacogenomics. The last ch
Trade Review
"The editors of this book successfully maintain a focus on those biomarkers used in the development of new drugs ... . Any statistician or scientist who seeks to wield pharmaceutical biomarkers on the quest for personalized medical certainty will find this book a timely and useful reference on a most important and fastest evolving subject." -Journal of Biopharmaceutical Statistics, 2015
Table of Contents
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.
