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

1. Clinical trial basics
2. Actionable prognostic biomarkers
3. Phase II designs
4. Enrichment designs
5. Including both test positive and test negative patients
6. Adaptive threshold design
7. Multiple predictive biomarkers predictive analysis of clinical trials
8. Prospective retrospective design
Appendix A. Statistics background
Appendix B. Prognostic classifiers based on high dimensional data.