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Suggested Citation:"References." Institute of Medicine. 2008. Diffusion and Use of Genomic Innovations in Health and Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12148.
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Page 85
Suggested Citation:"References." Institute of Medicine. 2008. Diffusion and Use of Genomic Innovations in Health and Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12148.
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Page 86
Suggested Citation:"References." Institute of Medicine. 2008. Diffusion and Use of Genomic Innovations in Health and Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12148.
×
Page 87
Suggested Citation:"References." Institute of Medicine. 2008. Diffusion and Use of Genomic Innovations in Health and Medicine: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12148.
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Page 88

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86 DIFFUSION AND USE OF GENOMIC INNOVATIONS CMS (Center for Medicare and Medicaid Services). 2007. Board of Trustees 2007 report. http:// www.cms.hhs.gov/ReportsTrustFunds/downloads/tr2007.pdf (accessed ­ February 12, 2008). Cobleigh, M. A., P. Bitterman, J. Baker, M. Cronin, M.-L. Liu, R. Borchik, B. Tabesh, J.-M. Mosquera, M. G. Walker, and S. Shak. 2003. Tumor gene expression predicts distant disease-free survival (DDFS) in breast cancer patients with 10 or more positive nodes: High throughput RT-PCR assay of paraffin-embedded tumor tissues. Proceedings of the American Society of Clinical Oncology 22:Abstract #3415. Collins, F. S., and V. A. McKusick. 2001. Implications of the human genome project for medi- cal science. JAMA 285:540-544. CTTI (Clinical Trials Transformation Initiative). 2007. Welcome to CTTI. https://www.­ trialstransformation.org/ (accessed March 11, 2008). DHHS (Department of Health and Human Services). 2007. Personalized health care. http:// www.hhs.gov/myhealthcare/ (accessed January 14, 2008). DiMasi, J. A., Hansen, R. W., and H. G. Grabowski. 2003. The price of innovation: New estimates of drug development costs. Journal of Health Economics 22(2):151-185. Eisenstein, E. L., P. W. Lemons 2nd, B. E. Tardiff, K. A. Schulman, M. K. Jolly, and R. M. Califf. 2005. Reducing the costs of phase III cardiovascular clinical trials. American Heart Jour- nal 149(3):482-488. Eisenstein, E. L., R. Collins, B. S. Cracknell, O. Podesta, E. D. Reid, P. Sandercock, Y. Shakhov, M. L. Terrin, M. A. Sellers, R. M. Califf, C. B. Granger, and R. Diaz. 2008. Sensible approaches for reducing clinical trial costs. Clinical Trials 5(1):75-84. Elkin, E. B., M. C. Weinstein, E. P. Winer, K. M. Kuntz, S. J. Schnitt, and J. C. Weeks. 2004. ������ HER-2 testing and trastuzumab therapy for metastatic breast cancer: A cost-effectiveness analysis. Journal of Clinical Oncology 22(5):854-863. Esteban, J., J. Baker, M. Cronin, et al. 2003. Tumor gene expression and prognosis in breast cancer: Multi-gene RT-PCR assay of paraffin-embedded tissue. Proceedings of the Ameri- can Society of Clinical Oncology 22:Abstract #3416. FDA (U.S. Food and Drug Administration). 2005. Pediatric exclusivity. http://www.fda.gov/ cder/ogd/pedtrac.htm (accessed March 11, 2008). FDA. 2006. Critical path opportunities report. http://www.fda.gov/oc/initiatives/criticalpath/ reports/opp_report.pdf (accessed February 6, 2008). Ferrusi, I. L., D. A. Marshall, N. A. Kulin, and K. A. Phillips. 2007. A systematic review of economic analyses of HER2 testing and trastuzumab therapy. Unpublished.  Garrison, L., and M. J. F. Austin. 2007. The economics of personalized medicine: A model of incentives for value creation and capture. Drug Information Journal 41:501-509. Gray, L. 2007. View from the trenches: Challenges and opportunities in personalized medicine. Presentation at the Institute of Medicine workshop on diffusion of genomic innovations in health and medicine. December 4. Washington, DC. Griliches, Z. 1957. Hybrid corn: An exploration in the economics of technological change. Econometrica 25(4):501-522. Harper, S., J. Lynch, S. Burris, and G. D. Smith. 2007. Trends in the black-white life expec- tancy gap in the United States, 1983-2003. JAMA 21(297):1224-1232. IOM (Institute of Medicine). 1992. Guidelines for clinical practice: From development to use. Washington, DC: National Academy Press. IOM. 2005. Implications of genomics for public health: Workshop summary. Washington, DC: The National Academies Press. Li, J. S., E. L. Eisenstein, H. G. Grabowski, E. D. Reid, B. Mangum, K. A. Schulman, J. F. Goldsmith, M. D. Murphy, R. M. Califf, and D. K. Benjamin. 2007. Economic ��������������� return of clinical trials performed under the pediatric exclusivity program. JAMA 297:480-488.

REFERENCES 87 Maller, J., S. George, S. Purcell, J. Fagerness, D. Altshuler, M. J. Daly, and J. M. Seddon. 2006. Common variation in three genes, including a noncoding variant in CFH, strongly influ- ences risk of age-related macular degeneration. Nature Genetics 38:1055-1059. Miranda, M. L., J. M. Silva, M. A. Overstreet Galeano, J. P. Brown, D. S. Campbell, E. Coley, C. S. Cowan, D. Harvell, J. Lassiter, J. L. Parks, and W. Sandele. 2005. Building geo- graphic information system capacity in local health departments: Lessons from a North Carolina project. American Journal of Public Health 95(12):2180-2185. Modeste, N. N. 1996. Dictionary of public health promotion and education: Terms and con- cepts. Thousand Oaks, CA: SAGE Publications. Nash, J. F. 1950. Equilibrium points in N-person games. Proceedings of the National Academy of Sciences 36:48-49. NHSE (National Health Service Executive). 1996. Promoting clinical effectiveness: A framework for action in and through the NHS. Leeds, UK: National Health Service Executive. Nissen, S. E., J. C. Tardif, S. J. Nicholls, J. H. Revkin, C. L. Shear, W. T. Duggan, W. Ruzyllo­, W. B. Bachinsky, G. P. Lasala, and E. M. Tazcu. 2007. Effect of ­torcetrapib on the progression of coronary atherosclerosis. New England Journal of Medicine 356(13):1304-1316. Oratz, R., D. Paul, A. L. Cohn, and S. M. Sedlacek. 2007. Impact of a commercial reference laboratory test recurrence score on decision making in early-stage breast cancer. Journal of Oncology Practice 3(4):182-186. Paik, S., S. Shak, G. Tang, C. Kim, J. Baker, M. Cronin, R. Baehner, M. Walker, D. Watson, T. Park, J. Bryant, and N. Wolmark. 2003. Multi-gene RT-PCR assay for predicting recurrence in node negative breast cancer patients—NSABP studies, B-20 and B-14. San Antonio Breast Cancer Symposium 2003. Abstract #16. Paik, S., S. Shak, G. Tang, C. Kim, H. Joo, J. Baker, M. Cronin, D. Watson, J. Bryant, J. Costantino, and N. Wolmark. 2004. Expression of the 21 genes in the Recurrence Score assay and prediction of clinical benefit from tamoxifen in NSABP study B-14 and chemotherapy in NSABP study B-20. San Antonio Breast Cancer Symposium 2004. Abstract #24. Pear, R. 2008 (March 23). Gap in life expectancy widens for the nation. New York Times. http://www.nytimes.com/2008/03/23/us/23health.html (accessed March 25, 2008). Phillips, K. A., and S. L. Van Bebber. 2004. A systematic review of cost-effectiveness analyses of pharmacogenomic interventions. Future Medicine 5(8):1139-1149. Phillips, K. A., and S. L. Van Bebber. 2005. Measuring the value of pharmacogenomics. Nature Reviews Drug Discovery 4(6):500-509. Phillips, K. A., D. L. Veenstra, S. Ramsey, S. L. Van Bebber, and J. Sakowski. 2004. Genetic testing and pharmacogenomics: Issues for determining the impact to health care delivery and costs. American Journal of Managed Care 10(7):425-432. Porter, M. E. 2006. Redefining health care: Creating value-based competition on results. Cambridge, MA: Harvard Business School Press. Rettenmaier, A. J., and T. R. Saving. 2004. The 2004 Medicare and Social Security trustees reports. National Center for Policy Analysis, Study No. 266. http://www.ncpa.org/pub/ st/st266/ (accessed February 12, 2008). Rieder, M. J., A. P. Reiner, B. F. Gage, D. A. Nickerson, C. S. Eby, H. L. McLeod, D. K. Blough, K. E. Thummel, D. L. Veenstra, and A. E. Rettie. 2005. Effect of VKORC1 haplotypes on transcriptional regulation and warfarin dose. New England Journal of Medicine 352:2285-2293.

88 DIFFUSION AND USE OF GENOMIC INNOVATIONS Roberts, J. S., S. A. LaRusse, H. Katzen, P. J. Whitehouse, M. Barber, S. G. Post, N. Relkin, K. Quaid, R. H. Pietrzak, A. Cupples, L. A. Farrer, T. Brown, and R. C. Green. 2003. Reasons for seeking genetic susceptibility testing among first-degree relatives of people with Alzheimer disease. Alzheimer Disease & Associated Disorders 17(2):86-93. Schumpeter, J. A. 1911. The theory of economic development: An inquiry into profits, capital, credit, interest, and the business cycle. Cambridge, MA: Harvard University Press. Shak, S. 2007. Introducing a genomic innovation to clinical practice. Presentation at the Insti- tute of Medicine workshop on diffusion of genomic innovations in health and medicine. December 4. Washington, DC. Trusheim, M. R., E. R. Berndt, and F. L. Douglas. 2007. Stratified medicine: Strategic and economic implications of combining drugs and clinical biomarkers. Nature Reviews Drug Discovery 6(4):287-293. Varmus, N. 2002. Getting ready for gene-based medicine. New England Journal of Medicine 347(19):1526-1527. Veenstra, D. L., M. K. Higashi, and K. A. Phillips. 2000. Assessing the cost-effectiveness of pharmacogenomics. AAPS PharmSci 2(3):Article 29. http://www.aapsj.org/view. asp?art=ps020329 (accessed February 13, 2008).

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Until fairly recently, genetic information was used primarily in the diagnosis of relatively rare genetic diseases, such as cystic fibrosis and Huntington's Disease, but a transformation in the use of genetic and genomic information is underway. While many predictions have been made that genomics will transform medicine, to date few of these promising discoveries have resulted in actual applications in medicine and health. The Institute of Medicine's Roundtable on Translating Genomic-Based Research for Health, established in 2007, held its first workshop to address the following questions: 1. Are there different pathways by which new scientific findings move from the research setting into health care? 2. If so, what are the implications of those different pathways for genomics? 3. What can we learn from the translation of other new technologies as we seek to understand the translation of genome science into health care? Information obtained from the workshop was then used to further discussion and exploration of the answers to these questions. This book summarizes speaker presentations and discussions. Any conclusions reported should not be construed as reflecting a group consensus; rather they are the statements and opinions of presenters and participants.

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