04584nam 2200805Ia 450 991096860420332120251017110100.01-283-63640-90-309-22419-5(CKB)2670000000275073(EBL)3379026(SSID)ssj0000665822(PQKBManifestationID)11422014(PQKBTitleCode)TC0000665822(PQKBWorkID)10646743(PQKB)10190436(MiAaPQ)EBC3379026(Au-PeEL)EBL3379026(CaPaEBR)ebr10606367(CaONFJC)MIL394886(OCoLC)923288397(DNLM)1634277(BIP)38954486(EXLCZ)99267000000027507320120911d2012 uy 0engurcn|||||||||txtccrEvolution 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 Academies1st ed.Washington, D.C. National Academies Pressc20121 online resource (338 p.)Description based upon print version of record.0-309-22418-7 Includes bibliographical references.""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""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.GenomicsTechnologyGenomicsData processingGenetic translationTechnologyBiomoleculesAnalysisBiomoleculesData processingBioinformaticsTechnologyBiotechnologyData miningAnalysisGenomicsTechnology.GenomicsData processing.Genetic translationTechnology.BiomoleculesAnalysis.BiomoleculesData processing.BioinformaticsTechnology.Biotechnology.Data miningAnalysis.572.33Micheel Christine1808125Nass Sharyl J857626Omenn Gilbert S1842458Institute of Medicine (U.S.).Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials.Institute of Medicine (U.S.).Board on Health Sciences Policy.National Academies Press (U.S.)MiAaPQMiAaPQMiAaPQBOOK9910968604203321Evolution of translational omics4446604UNINA