References

Ad Hoc Committee on Genetic Counseling, American Society of Human Genetics. 1975. Genetic counseling. American Journal of Human Genetics 27:240-242.

Astrazeneca. 2006. Annual results presentation. Jon Symonds. http://www.astrazeneca.com/sites/7/imagebank/typearticleparam511711/astrazeneca-fourth-quarter-2006-jrs-script.pdf.pdf (accessed January 18, 2008).

Baigent, C., F. E. Harrell, M. Buyse, J. R. Emberson, and D. G. Altman. 2008. Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clinical Trials 5(1):49-55.

Benjamin, D. K., P. B. Smith, M. D. Murphy, R. Roberts, L. Mathis, D. Avant, M. Califf, and J. S. Li. 2006. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA 296:1266-1273.

Buckley, T. 2007. The complexities of comparative effectiveness. Biotechnology Industry Organization. http://bio.org/healthcare/compeffective/20071025.pdf (accessed April 29, 2008).

Burke, W. 2007. Integrating genetic technology into a health care system. Presentation at the Institute of Medicine workshop on diffusion of genomic innovations in health and medicine. December 4. Washington, DC.

Burke, W., and B. M. Psaty. 2007. Personalized medicine in the era of genomics. JAMA 298(14):1682-1684.

Burke, W., and R. L. Zimmern. 2004. Ensuring the appropriate use of genetic tests. Nature Reviews Genetics 5(12):955-959.

Burke, W., M. J. Khoury, A. Stewart, and R. Zimmern. 2006. The path from genome-based research to population health: Development of an international public health genomics network. Genetics in Medicine 8:451-458.

Califf, R. 2007. Translation of innovations: A broad perspective. Presentation at the Institute of Medicine workshop on diffusion of genomic innovations in health and medicine. December 4. Washington, DC.

Center on Budget and Policy Priorities. 2006. The number of uninsured Americans is at an all-time high. http://www.cbpp.org/8-29-06health.htm (accessed January 16, 2008).



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 85
References Ad Hoc Committee on Genetic Counseling, American Society of Human Genetics. 1975. Genetic counseling. American Journal of Human Genetics 27:240-242. Astrazeneca. 2006. Annual results presentation. Jon Symonds. http://www.astrazeneca.com/ sites/7/imagebank/typearticleparam511711/astrazeneca-fourth-quarter-2006-jrs-script. pdf.pdf (accessed January 18, 2008). Baigent, C., F. E. Harrell, M. Buyse, J. R. Emberson, and D. G. Altman. 2008. Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clinical Trials 5(1):49-55. Benjamin, D. K., P. B. Smith, M. D. Murphy, R. Roberts, L. Mathis, D. Avant, M. Califf, and J. S. Li. 2006. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA 296:1266-1273. Buckley, T. 2007. The complexities of comparative effectiveness. Biotechnology Industry Organization. http://bio.org/healthcare/compeffective/20071025.pdf (accessed April 29, 2008). Burke, W. 2007. Integrating genetic technology into a health care system. Presentation at the Institute of Medicine workshop on diffusion of genomic innovations in health and medicine. December 4. Washington, DC. Burke, W., and B. M. Psaty. 2007. Personalized medicine in the era of genomics. JAMA 298(14):1682-1684. Burke, W., and R. L. Zimmern. 2004. Ensuring the appropriate use of genetic tests. Nature Reviews Genetics 5(12):955-959. Burke, W., M. J. Khoury, A. Stewart, and R. Zimmern. 2006. The path from genome-based research to population health: Development of an international public health genomics network. Genetics in Medicine 8:451-458. Califf, R. 2007. Translation of innovations: A broad perspective. Presentation at the Institute of Medicine workshop on diffusion of genomic innovations in health and medicine. December 4. Washington, DC. Center on Budget and Policy Priorities. 2006. The number of uninsured Americans is at an all-time high. http://www.cbpp.org/8-29-06health.htm (accessed January 16, 2008). 

OCR for page 85
 DIFFUSION AND USE OF GENOMIC INNOVATIONS CMS (Center for Medicare and Medicaid Services). 2007. Board of Trustees 00 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 HER 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.

OCR for page 85
 REFERENCES 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-0 and B-. 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  genes in the Recurrence Score assay and prediction of clinical benefit from tamoxifen in NSABP study B- and chemotherapy in NSABP study B-0. 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 00 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.

OCR for page 85
 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).