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Suggested Citation:"Appendix C: Statement of Task." Institute of Medicine. 2014. Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18799.
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Appendix C

Statement of Task

An ad hoc planning committee will organize and conduct a public workshop to examine the process for evaluating evidence for genomic applications. The workshop goal is to evaluate how evidence for genomic applications is gathered and assessed for clinical decision making, reimbursement decisions, and guideline development in the absence of an ideal information base. The workshop will also address how evidence is evaluated for determining what secondary genome sequencing information should be returned to patients. Current models will be evaluated to advance discussions among diverse stakeholder groups which may include academic researchers, industry and professional society representatives, clinicians, patients, payers, and laboratory test developers. The planning committee will develop the workshop agenda, select speakers and discussants, and moderate the discussions. An individually authored summary of the workshop will be prepared by a designated rapporteur in accordance with institutional policy and procedures.

Suggested Citation:"Appendix C: Statement of Task." Institute of Medicine. 2014. Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18799.
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Suggested Citation:"Appendix C: Statement of Task." Institute of Medicine. 2014. Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18799.
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Page 97
Suggested Citation:"Appendix C: Statement of Task." Institute of Medicine. 2014. Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18799.
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Page 98
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Rapid advances in technology have lowered the cost of sequencing an individual's genome from the several billion dollars that it cost a decade ago to just a few thousand dollars today and have correspondingly greatly expanded the use of genomic information in medicine. Because of the lack of evidence available for assessing variants, evaluation bodies have made only a few recommendations for the use of genetic tests in health care. For example, organizations, such as the Evaluation of Genomic Applications in Practice and Prevention working group, have sought to set standards for the kinds of evaluations needed to make population-level health decisions. However, due to insufficient evidence, it has been challenging to recommend the use of a genetic test. An additional challenge to using large-scale sequencing in the clinic is that it may uncover "secondary," or "incidental," findings - genetic variants that have been associated with a disease but that are not necessarily related to the conditions that led to the decision to use genomic testing. Furthermore, as more genetic variants are associated with diseases, new information becomes available about genomic tests performed previously, which raises issues about how and whether to return this information to physicians and patients and also about who is responsible for the information.

To help develop a better understanding of how genomic information is used for healthcare decision making, the Roundtable on Translating Genomic-Based Research for Health of the Institute of Medicine held a workshop in Washington,DC in February 2014. Stakeholders, including clinicians, researchers, patients, and government officials, discussed the issues related to the use of genomic information in medical practice. Assessing Genomic Sequencing Information for Health Care Decision Making is the summary of that workshop. This report compares and contrasts evidence evaluation processes for different clinical indications and discusses key challenges in the evidence evaluation process.

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