Dr Richard M. Simon is chief of the Biometric Research Branch of the National Cancer Institute, where he is chief statistician for the Division of Cancer Treatment and Diagnosis. He is the lead author of the textbook Design and Analysis of DNA Microarray Experiments and has more than 450 publications. Simon has been influential in promoting excellence in clinical trial design and analysis. He has served on the Oncologic Advisory Committee of the US Food and Drug Administration and is a frequent advisor to government, academic and industry organizations involved with developing improved treatments and diagnostics for patients with cancer. In 1998 Dr Simon established the Molecular Statistics and Bioinformatics Section of the National Cancer Institute, a multidisciplinary group of scientists developing and applying methods for the application of genomics to cancer therapeutics. He is the architect of BRB-ArrayTools software for the analysis of microarray expression and copy number data.

'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

• 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.