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 medical 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 Journal 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 American 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 expectancy 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.