Genomic Clinical Trials and Predictive Medicine

This book focuses on novel approaches that provide a reliable basis for identifying what kinds of patients are likely to benefit from the each new treatment.

Richard M. Simon (Author)

9781107401358, Cambridge University Press

Paperback / softback, published 7 January 2013

150 pages, 11 b/w illus. 3 tables
24.6 x 17.5 x 1 cm, 0.31 kg

'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

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.

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.

Subject Areas: Epidemiology & medical statistics [MBNS], Clinical trials [MBGR1]