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Excerpt
A major impediment to the integration of these genomic tests into routine health care is the lack of an adequate evidence base linking the use of genomic diagnostic tests to health outcomes. Since these new technologies are beginning to play an increased role in clinical decision-making and the management of disease, the Institute of Medicine's Roundtable on Translating Genomic-Based Research for Health hosted a public workshop on November 17, 2010, to explore issues related to this lack of evidence. Various stakeholders, including regulators and policymakers, payers, healthcare providers, researchers, funders, and evidence-based review groups, were invited to share their perspectives on the strengths and limitations of the evidence being generated to assess the clinical validity and utility of genomic diagnostic tests. Specifically, panelists were asked to address the following:
- What evidence is required by stakeholders (e.g., for decisions regarding clearance, use, and reimbursement)?
- How is evidence currently being generated?
- Are there innovative and efficient ways to generate high-quality evidence?
- How can the barriers to generating this evidence be overcome?
Contents
- The National Academies
- Planning Committee
- Roundtable on Translating Genomic-Based Research for Health
- Reviewers
- Acknowledgments
- 1. Introduction
- 2. Stakeholder Perspectives on Evidence
- 3. Approaches to Evidence Generation
- 4. Overcoming Barriers for Evidence Generation
- 5. Considerations Moving Forward
- 6. Final Remarks
- Abbreviations and Acronyms
- References
- Appendixes
Rapporteurs: Theresa Wizemann and Adam C Berger
This project was supported by contracts between the National Academy of Sciences and the American College of Medical Genetics (unnumbered contract); American Medical Association (unnumbered contract); American Nurses Association (unnumbered contract); Blue Cross and Blue Shield Association (unnumbered contract); Centers for Disease Control and Prevention (Contract No. 200-2005-13434); College of American Pathologists (unnumbered contract); Department of the Air Force (Contract No. FA7014-10-P-0072); Department of Veterans Affairs (Contract No. V101(93) P-2238); Eli Lilly and Company (Contract No. LRL-0028-07); Genetic Alliance (unnumbered contract); Health Resources and Services Administration; Johnson & Johnson (unnumbered contract); Kaiser Permanente (unnumbered contract); National Cancer Institute (Contract No. N01-OD-4-2139, TO#189); National Heart, Lung, and Blood Institute (Contract No. N01-OD-4-2139, TO#189); National Human Genome Research Institute (Contract No. N01-OD-4-2139, TO#189); National Society of Genetic Counselors (unnumbered contract); and Pfizer Inc. (Contract No. 140-N-1818071).
Suggested citation:
IOM (Institute of Medicine). 2011. Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary. Washington, DC: The National Academies Press.
NOTICE: Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for the project. The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
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