Evolution of Translational Omics

Evolution of Translational Omics

Lessons Learned and the Path Forward

  • Author: Omenn, Gilbert S.; Nass, Sharly J.; Micheel, Christine M.
  • Publisher: National Academies Press
  • ISBN: 9780309224185
  • eISBN Pdf: 9780309224192
  • Place of publication:  United States
  • Year of digital publication: 2012
  • Month: August
  • Pages: 355
  • DDC: 576
  • Language: English

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.

  • FrontMatter
  • Reviewers
  • Acknowledgments
  • Contents
  • Boxes, Figures, and Tables
  • 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 Expression–Based 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

Subjects

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