1. Ad Hoc Committee on Genetic Counseling; American Society of Human Genetics. Genetic counseling. American Journal of Human Genetics. 1975;27:240–242. [PMC free article: PMC1762759] [PubMed: 1124768]
  2. Symonds J.Astrazeneca Annual results presentation 2006. [accessed January 18, 2008].
  3. Baigent C, Harrell FE, Buyse M, Emberson JR, Altman DG. Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clinical Trials. 2008;5(1):49–55. [PubMed: 18283080]
  4. Benjamin DK, Smith PB, Murphy MD, Roberts R, Mathis L, Avant D, Califf M, Li JS. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA. 2006;296:1266–1273. [PMC free article: PMC2773660] [PubMed: 16968851]
  5. Buckley T.Biotechnology Industry Organization; 2007. [accessed April 29, 2008]. The complexities of comparative effectiveness.
  6. Burke W.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, 2007; Washington, DC.
  7. Burke W, Psaty BM. Personalized medicine in the era of genomics. JAMA. 2007;298(14):1682–1684. [PubMed: 17925520]
  8. Burke W, Zimmern RL. Ensuring the appropriate use of genetic tests. Nature Reviews Genetics. 2004;5(12):955–959. [PubMed: 15573127]
  9. Burke W, Khoury MJ, Stewart A, Zimmern R. The path from genome-based research to population health: Development of an international public health genomics network. Genetics in Medicine. 2006;8:451–458. [PubMed: 16845279]
  10. Califf R.Translation of innovations: A broad perspective. Presentation at the Institute of Medicine workshop on diffusion of genomic innovations in health and medicine; December 4, 2007; Washington, DC.
  11. Center on Budget and Policy Priorities. The number of uninsured Americans is at an all-time high. 2006. [accessed January 16, 2008].
  12. CMS (Center for Medicare and Medicaid Services) Board of Trustees 2007 report. 2007. [accessed February 12, 2008].
  13. Cobleigh MA, Bitterman P, Baker J, Cronin M, Liu ML, Borchik R, Tabesh B, Mosquera JM, Walker MG, Shak S. 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. 2003;22(Abstract #3415.)
  14. Collins FS, McKusick VA. Implications of the human genome project for medical science. JAMA. 2001;285:540–544. [PubMed: 11176855]
  15. CTTI (Clinical Trials Transformation Initiative) Welcome to CTTI. 2007. [accessed March 11, 2008].
  16. DHHS (Department of Health and Human Services) Personalized health care. 2007. [accessed January 14, 2008].
  17. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: New estimates of drug development costs. Journal of Health Economics. 2003;22(2):151–185. [PubMed: 12606142]
  18. Eisenstein EL, Lemons PW 2nd, Tardiff BE, Schulman KA, Jolly MK, Califf RM. Reducing the costs of phase III cardiovascular clinical trials. American Heart Journal. 2005;149(3):482–488. [PubMed: 15864237]
  19. Eisenstein EL, Collins R, Cracknell BS, Podesta O, Reid ED, Sandercock P, Shakhov Y, Terrin ML, Sellers MA, Califf RM, Granger CB, Diaz R. Sensible approaches for reducing clinical trial costs. Clinical Trials. 2008;5(1):75–84. [PubMed: 18283084]
  20. Elkin EB, Weinstein MC, Winer EP, Kuntz KM, Schnitt SJ, Weeks JC. HER-2 testing and trastuzumab therapy for metastatic breast cancer: A cost-effectiveness analysis. Journal of Clinical Oncology. 2004;22(5):854–863. [PubMed: 14990641]
  21. Esteban J, Baker J, Cronin M. Tumor gene expression and prognosis in breast cancer: Multi-gene RT-PCR assay of paraffin-embedded tissue. Proceedings of the American Society of Clinical Oncology. 2003;22(Abstract #3416.)
  22. FDA (U.S. Food and Drug Administration) Pediatric exclusivity. 2005. [accessed March 11, 2008].
  23. FDA. Critical path opportunities report. 2006. [accessed February 6, 2008].
  24. Ferrusi IL, Marshall DA, Kulin NA, Phillips KA. A systematic review of economic analyses of HER2 testing and trastuzumab therapy. 2007. Unpublished. [PMC free article: PMC2910630] [PubMed: 20668661]
  25. Garrison L, Austin MJF. The economics of personalized medicine: A model of incentives for value creation and capture. Drug Information Journal. 2007;41:501–509.
  26. Gray L.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, 2007; Washington, DC.
  27. Griliches Z. Hybrid corn: An exploration in the economics of technological change. Econometrica. 1957;25(4):501–522.
  28. Harper S, Lynch J, Burris S, Smith GD. Trends in the black-white life expectancy gap in the United States, 1983-2003. JAMA. 2007;21(297):1224–1232. [PubMed: 17369405]
  29. IOM (Institute of Medicine) Guidelines for clinical practice: From development to use. Washington, DC: National Academy Press; 1992.
  30. IOM. Implications of genomics for public health: Workshop summary. Washington, DC: The National Academies Press; 2005.
  31. Li JS, Eisenstein EL, Grabowski HG, Reid ED, Mangum B, Schulman KA, Goldsmith JF, Murphy MD, Califf RM, Benjamin DK. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA. 2007;297:480–488. [PMC free article: PMC2773665] [PubMed: 17284698]
  32. Maller J, George S, Purcell S, Fagerness J, Altshuler D, Daly MJ, Seddon JM. Common variation in three genes, including a noncoding variant in CFH, strongly influences risk of age-related macular degeneration. Nature Genetics. 2006;38:1055–1059. [PubMed: 16936732]
  33. Miranda ML, Silva JM, Overstreet Galeano MA, Brown JP, Campbell DS, Coley E, Cowan CS, Harvell D, Lassiter J, Parks JL, Sandele W. Building geographic information system capacity in local health departments: Lessons from a North Carolina project. American Journal of Public Health. 2005;95(12):2180–2185. [PMC free article: PMC1449504] [PubMed: 16257950]
  34. Modeste NN. Dictionary of public health promotion and education: Terms and concepts. Thousand Oaks, CA: SAGE Publications; 1996.
  35. Nash JF. Equilibrium points in N-person games. Proceedings of the National Academy of Sciences. 1950;36:48–49. [PMC free article: PMC1063129] [PubMed: 16588946]
  36. NHSE (National Health Service Executive) Promoting clinical effectiveness: A framework for action in and through the NHS. Leeds, UK: National Health Service Executive; 1996.
  37. Nissen SE, Tardif JC, Nicholls SJ, Revkin JH, Shear CL, Duggan WT, Ruzyllo W, Bachinsky WB, Lasala GP, Tazcu EM. Effect of torcetrapib on the progression of coronary atherosclerosis. New England Journal of Medicine. 2007;356(13):1304–1316. [PubMed: 17387129]
  38. Oratz R, Paul D, Cohn AL, Sedlacek SM. Impact of a commercial reference laboratory test recurrence score on decision making in early-stage breast cancer. Journal of Oncology Practice. 2007;3(4):182–186. [PMC free article: PMC2793805] [PubMed: 20859407]
  39. Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner R, Walker M, Watson D, Park T, Bryant J, Wolmark N.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.
  40. Paik S, Shak S, Tang G, Kim C, Joo H, Baker J, Cronin M, Watson D, Bryant J, Costantino J, Wolmark N.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.
  41. Pear R.Gap in life expectancy widens for the nation. New York Times (March 23, 2008). [accessed March 25, 2008].
  42. Phillips KA, Van Bebber SL. A systematic review of cost-effectiveness analyses of pharmacogenomic interventions. Future Medicine. 2004;5(8):1139–1149. [PubMed: 15584880]
  43. Phillips KA, Van Bebber SL. Measuring the value of pharmacogenomics. Nature Reviews Drug Discovery. 2005;4(6):500–509. [PubMed: 15915153]
  44. Phillips KA, Veenstra DL, Ramsey S, Van Bebber SL, Sakowski J. Genetic testing and pharmacogenomics: Issues for determining the impact to health care delivery and costs. American Journal of Managed Care. 2004;10(7):425–432. [PubMed: 15298364]
  45. Porter ME. Redefining health care: Creating value-based competition on results. Cambridge, MA: Harvard Business School Press; 2006.
  46. Rettenmaier AJ, Saving TR.The 2004 Medicare and Social Security trustees reports. National Center for Policy Analysis, Study No. 266. 2004. [accessed February 12, 2008].
  47. Rieder MJ, Reiner AP, Gage BF, Nickerson DA, Eby CS, McLeod HL, Blough DK, Thummel KE, Veenstra DL, Rettie AE. Effect of VKORC1 haplotypes on transcriptional regulation and warfarin dose. New England Journal of Medicine. 2005;352:2285–2293. [PubMed: 15930419]
  48. Roberts JS, LaRusse SA, Katzen H, Whitehouse PJ, Barber M, Post SG, Relkin N, Quaid K, Pietrzak RH, Cupples A, Farrer LA, Brown T, Green RC. Reasons for seeking genetic susceptibility testing among first-degree relatives of people with Alzheimer disease. Alzheimer Disease & Associated Disorders. 2003;17(2):86–93. [PubMed: 12794385]
  49. Schumpeter JA. The theory of economic development: An inquiry into profits, capital, credit, interest, and the business cycle. Cambridge, MA: Harvard University Press; 1911.
  50. Shak S.Introducing a genomic innovation to clinical practice; Presentation at the Institute of Medicine workshop on diffusion of genomic innovations in health and medicine; December 4, 2007; Washington, DC.
  51. Trusheim MR, Berndt ER, Douglas FL. Stratified medicine: Strategic and economic implications of combining drugs and clinical biomarkers. Nature Reviews Drug Discovery. 2007;6(4):287–293. [PubMed: 17380152]
  52. Varmus N. Getting ready for gene-based medicine. New England Journal of Medicine. 2002;347(19):1526–1527. [PubMed: 12421898]
  53. Veenstra DL, Higashi MK, Phillips KA.Assessing the cost-effectiveness of pharmacogenomics. AAPS PharmSci. 2000. [accessed February 13, 2008]. p. Article 29. [PMC free article: PMC2761139] [PubMed: 11741245]