Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary

✍ Scribed by Roundtable on Translating Genomic-Based Research for Health, theresa Wizemann, Institute of Medicine (Adam C. Berger)

• Publisher: The National Academies Press
• Year: 2011
• Tongue: English
• Leaves: 107
• Category: Library

✦ Synopsis

Ten years after the sequencing of the human genome, scientists have developed genetic tests that can predict a person's response to certain drugs, estimate the risk of developing Alzheimer's disease, and make other predictions based on known links between genes and diseases. However, genetic tests have yet to become a routine part of medical care, in part because there is not enough evidence to show they help improve patients' health.The Institute of Medicine (IOM) held a workshop to explore how researchers can gather better evidence more efficiently on the clinical utility of genetic tests. Generating Evidence for Genomic Diagnostic Test Development compares the evidence that is required for decisions regarding clearance, use, and reimbursement, to the evidence that is currently generated. The report also addresses innovative and efficient ways to generate high-quality evidence, as well as barriers to generating this evidence. Generating Evidence for Genomic Diagnostic Test Development contains information that will be of great value to regulators and policymakers, payers, health-care providers, researchers, funders, and evidence-based review groups.--Publisher's description.

✦ Table of Contents

FrontMatter......Page 2
Reviewers......Page 12
Acknowledgments......Page 14
Contents......Page 16
Tables, Figures, and Boxes......Page 18
Abbreviations and Acronyms......Page 20
1 Introduction......Page 22
2 Stakeholder Perspectives on Evidence......Page 26
3 Approaches to Evidence Generation......Page 46
4 Overcoming Barriers for Evidence Generation......Page 64
5 Considerations Moving Forward......Page 74
6 Final Remarks......Page 80
References......Page 84
Appendix A: Workshop Agenda......Page 88
Appendix B: Speaker Biographical Sketches......Page 92
Appendix C: Registered Attendees......Page 102