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Genomics is majorly impacting therapeutics development in medicine. This book contains up-to-date information on the use of genomics in the design and analysis of therapeutic clinical trials with a focus on novel approaches that provide a reliable basis for identifying which patients are most likely to benefit from each treatment. It is oriented to both clinical investigators and statisticians. For clinical investigators, it includes background information on clinical trial design and statistical analysis. For statisticians and others who want to go deeper, it covers state-of-the-art adaptive designs and the development and validation of probabilistic classifiers. The author describes the development and validation of prognostic and predictive biomarkers and their integration into clinical trials that establish their clinical utility for informing treatment decisions for future patients.
Table of Contents
Clinical trial basics
Actionable prognostic biomarkers
Phase II designs
Including both test positive and test negative patients
Adaptive threshold design
Multiple predictive biomarkers predictive analysis of clinical trials
Prospective - retrospective design
Prognostic classifiers based on high dimensional data
Table of Contents provided by Publisher. All Rights Reserved.