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Evolution of translational omics : lessons learned and the path forward / 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 ; Christine M. Micheel, Sharyl J. Nass, and Gilbert S. Omenn, editors ; Institutes of Medicine of the National Academies.
- Format:
- Book
- Language:
- English
- Subjects (All):
- Genomics--Technology.
- Genomics.
- Genomics--Data processing.
- Genetic translation--Technology.
- Genetic translation.
- Biomolecules--Analysis.
- Biomolecules.
- Biomolecules--Data processing.
- Bioinformatics--Technology.
- Bioinformatics.
- Biotechnology.
- Data mining--Analysis.
- Data mining.
- Physical Description:
- 1 online resource (338 p.)
- Edition:
- 1st ed.
- Place of Publication:
- Washington, D.C. : National Academies Press, c2012.
- Language Note:
- English
- Summary:
- 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.
- Contents:
- ""Front Matter""; ""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""
- Notes:
- Description based upon print version of record.
- Includes bibliographical references.
- ISBN:
- 1-283-63640-9
- 0-309-22419-5
- OCLC:
- 923288397
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