Genomic Clinical Trials and Predictive Medicine
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.
- Book presents new clinical trials designs and statistical analysis for personalized medicine
- Discusses novel methods for analyzing clinical trials for personalizing treatment decisions
- Covers state-of-the-art adaptive designs and the development and validation of probabilistic classifiers
Reviews & endorsements
"This book will be a valuable resource to those involved in genomic clinical trials. The author touches on many of the important issues in this field and provides a useful selection of approaches to handling them."
Matthew Schipper, International Statistical Review
Product details
January 2013Adobe eBook Reader
9781107302358
0 pages
0kg
11 b/w illus. 3 tables
This ISBN is for an eBook version which is distributed on our behalf by a third party.
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.