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Record Nr. |
UNINA9911143556803321 |
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Titolo |
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 |
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Pubbl/distr/stampa |
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Washington, D.C., : National Academies Press, c2012 |
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ISBN |
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1-283-63640-9 |
0-309-22419-5 |
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Edizione |
[1st ed.] |
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Descrizione fisica |
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1 online resource (338 p.) |
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Altri autori (Persone) |
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MicheelChristine |
NassSharyl J |
OmennGilbert S |
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Disciplina |
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Soggetti |
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Genomics - Technology |
Genomics - Data processing |
Genetic translation - Technology |
Biomolecules - Analysis |
Biomolecules - Data processing |
Bioinformatics - Technology |
Biotechnology |
Data mining - Analysis |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references. |
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Nota di contenuto |
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""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"" |
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""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"" |
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Sommario/riassunto |
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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. |
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