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Genomic Clinical Trials and Predictive Medicine Richard M. Simon

Genomic Clinical Trials and Predictive Medicine By Richard M. Simon

Genomic Clinical Trials and Predictive Medicine by Richard M. Simon


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Summary

This book focuses on novel approaches that provide a reliable basis for identifying which patients are likely to benefit from each treatment. Aimed at both clinical investigators and statisticians, it covers the development and validation of prognostic and predictive biomarkers and their integration into clinical trials.

Genomic Clinical Trials and Predictive Medicine Summary

Genomic Clinical Trials and Predictive Medicine by Richard M. Simon

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.

Genomic Clinical Trials and Predictive Medicine Reviews

'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

About Richard M. Simon

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.

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.

Additional information

NLS9781107401358
9781107401358
1107401356
Genomic Clinical Trials and Predictive Medicine by Richard M. Simon
New
Paperback
Cambridge University Press
2013-01-07
150
N/A
Book picture is for illustrative purposes only, actual binding, cover or edition may vary.
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Customer Reviews - Genomic Clinical Trials and Predictive Medicine