Clinical and Statistical Considerations in Personalized Medicine

The Future of Clinical Research and Health Care: From Empirical to Precision MedicineClinical 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 TreatmentThe 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 chapter assesses the regulatory issues involved in using biomarkers.

Improve Patient Care and Reduce Costs and Side EffectsDespite 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. Covering a wide spectrum of personalized medicine-related topics, it presents state-of-the-art techniques for advancing the application of biomarkers in drug discovery and development.

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.