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.


Table of Contents


Front Matter
Summary
1 Introduction
2 Omics-Based Clinical Discovery: Science, Technology, and
Applications
3 Best Practices for Omics-Based Test Validation Prior to Use for
Patient Management Decisions in a Clinical Trial Setting
4 Evaluation of Omics-Based Tests for Clinical Utility and Use
5 Responsible Parties
6 Lessons from the Case Studies
Appendix A: Case Studies
Appendix B: Gene ExpressionBased Tests Developed at Duke University
and Used in Clinical Trials
Appendix C: Introduction to Biomarkers
Appendix D: Reporting Guidelines
Appendix E: Committee Member and Staff Biographies
Appendix F: Information Gathering Sessionsand Speakers
Acronyms and Abbreviations
Glossary