Evolution of Translational Omics: Lessons Learned and the Path Forward

Institute of Medicine

doi:10.17226/13297

Consensus Study Report

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Evolution of Translational Omics

Lessons Learned and the Path Forward

(2012)

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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.

Contributor(s): Institute of Medicine; Board on Health Care Services; Board on Health Sciences Policy; Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials; Christine M. Micheel, Sharly J. Nass, and Gilbert S. Omenn, Editors

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Institute of Medicine. 2012. Evolution of Translational Omics: Lessons Learned and the Path Forward. Washington, DC: The National Academies Press. https://doi.org/10.17226/13297.

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354 pages | 6 x 9 |

ISBNs:

Paperback: 978-0-309-22418-5
Ebook: 978-0-309-22422-2

DOI: https://doi.org/10.17226/13297

Chapters		skim
Front Matter	i-xvi
Summary	1-16
1 Introduction	17-32
2 Omics-Based Clinical Discovery: Science, Technology, and Applications	33-64
3 Best Practices for Omics-Based Test Validation Prior to Use for Patient Management Decisions in a Clinical Trial Setting	65-78
4 Evaluation of Omics-Based Tests for Clinical Utility and Use	79-104
5 Responsible Parties	105-162
6 Lessons from the Case Studies	163-182
Appendix A: Case Studies	183-238
Appendix B: Gene ExpressionBased Tests Developed at Duke University and Used in Clinical Trials	239-280
Appendix C: Introduction to Biomarkers	281-288
Appendix D: Reporting Guidelines	289-300
Appendix E: Committee Member and Staff Biographies	301-318
Appendix F: Information Gathering Sessionsand Speakers	319-322
Acronyms and Abbreviations	323-326
Glossary	327-338

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