Evolution of Translational Omics:

Lessons Learned and the Path Forward

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Size: 354 pages, 6 x 9

Publication Year:2012

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PAPERBACK ISBN-10: 0-309-22418-7 ISBN-13: 978-0-309-22418-5	$64.00	Add to Cart

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Authors:
Christine M. Micheel, Sharyl J. Nass, and Gilbert S. Omenn, Editors; Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials; Board on Health Care Services; Board on Health Sciences Policy; Institute of Medicine
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Table of Contents
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Front Matter	i-xvi
Summary	1-16	(skim)
1 Introduction	17-32	(skim)
2 Omics-Based Clinical Discovery: Science, Technology, and Applications	33-64	(skim)
3 Best Practices for Omics-Based Test Validation Prior to Use for Patient Management Decisions in a Clinical Trial Setting	65-78	(skim)
4 Evaluation of Omics-Based Tests for Clinical Utility and Use	79-104	(skim)
5 Responsible Parties	105-162	(skim)
6 Lessons from the Case Studies	163-182	(skim)
Appendix A: Case Studies	183-238	(skim)
Appendix B: Gene ExpressionBased Tests Developed at Duke University and Used in Clinical Trials	239-280	(skim)
Appendix C: Introduction to Biomarkers	281-288	(skim)
Appendix D: Reporting Guidelines	289-300	(skim)
Appendix E: Committee Member and Staff Biographies	301-318	(skim)
Appendix F: Information Gathering Sessionsand Speakers	319-322	(skim)
Acronyms and Abbreviations	323-326	(skim)
Glossary	327-338	(skim)

Description

Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

Evolution of Translational Omics:

Lessons Learned and the Path Forward

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