| Description |
1 online resource (1 PDF file (xv, 338 pages) : illustrations |
| Series |
Online access: National Academy of Sciences National Academies Press
|
|
Online access: NCBI NCBI Bookshelf
|
| Contents |
Introduction -- Omics-based clinical discovery: science, technology and applications -- Best practices for omics-based test validation prior to use for patient management decisions in a clinical trial setting -- Evaluation of omics-based tests for clinical utility and use -- Responsible parties -- Lessons from the case studies |
| 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 |
| Notes |
Title from PDF title page |
| Bibliography |
Includes bibliographical references |
| Notes |
This study was supported by Contract Nos. HHSN261200900003C (National Cancer Institute); HHSF223201010692P and HHSF22301018T (Food and Drug Administration); and 200-2011-38807 and 200-2005-13434 (Centers for Disease Control and Prevention). This study was also supported by the U.S. Department of Veterans Affairs, the American Society for Clinical Pathology, and the College of American Pathologists. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project |
|
Version viewed August 15, 2014 |
| Subject |
Genomics -- Technology
|
|
Genomics -- Data processing
|
|
Genetic translation -- Technology
|
|
Biomolecules -- Analysis
|
|
Biomolecules -- Data processing
|
|
Bioinformatics -- Technology
|
|
Data mining -- Analysis
|
|
Biotechnology.
|
|
Genomics.
|
|
Genomics
|
|
Validation Studies as Topic
|
|
Molecular Diagnostic Techniques
|
|
Biotechnology
|
|
Translational Research, Biomedical
|
|
bioengineering.
|
|
SCIENCE -- Life Sciences -- Biochemistry.
|
|
Genomics
|
|
Biomolecules -- Analysis
|
|
Biotechnology
|
|
Genomics -- Data processing
|
| Form |
Electronic book
|
| Author |
Micheel, Christine, editor
|
|
Nass, Sharyl J., editor
|
|
Omenn, Gilbert S., editor
|
|
Institute of Medicine (U.S.). Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials, sponsoring body.
|
| LC no. |
2012472477 |
| ISBN |
9780309224192 |
|
0309224195 |
|
