• Front Matter R1-R16

• 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

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 " Summary ." Evolution of Translational Omics: Lessons Learned and the Path Forward . Washington, DC: The National Academies Press, 2012 .

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