Available:*
Library | Item Barcode | Call Number | Material Type | Item Category 1 | Status |
---|---|---|---|---|---|
Searching... | 30000010342146 | RM301.3 G45 C58 2014 | Open Access Book | Book | Searching... |
On Order
Summary
Summary
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.
Author Notes
Claudio Carini, Sandeep Menon, Mark Chang
Table of Contents
Introduction to Biomarkers and Personalized Medicine |
System Biology in the Context of Personalized Medicine |
EpiGenetics in the Context of Personalized Medicine |
Biomarker Development and Validation: Statistical Considerations |
Multiplicity: Overview and Issues in Subgroup Selection |
Multiplicity in Pharmacogenomics Studies |
Dose Response Model Considerations from a Biomarker Perspective |
Designs for Targeted Therapy: Classical Designs |
Designs for Targeted Therapy: Adaptive Designs |
Evidence-Based Adaptive Statistical Decision and Design Strategies for Maximizing the Efficiency of Clinical Oncology Development Programs with Predictive Biomarkers |
Outcomes Research in Personalized Medicine |
Biomarkers: Some Regulatory Considerations |