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Suggested Citation:"References." Institute of Medicine. 2009. Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12691.
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Page 69
Suggested Citation:"References." Institute of Medicine. 2009. Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12691.
×
Page 70
Suggested Citation:"References." Institute of Medicine. 2009. Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12691.
×
Page 71
Suggested Citation:"References." Institute of Medicine. 2009. Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12691.
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Page 72

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References Anderson, J. L., B. D. Horne, S. M. Stevens, A. S. Grove, S. Barton, Z. P. Nicholas, S. F. Kahn, H. T. May, K. M. Samuelson, J. B. Muhlestein, and J. F. Carlquist. 2007. Randomized trial of genotype-guided versus standard warfarin dosing in patients initiating oral anti- coagulation. Circulation 116(22):2563-2570. Burke, W., and R. L. Zimmern. 2004. Ensuring the appropriate use of genetic tests. Nat Rev Genet 5(12):955-959. Califf, R. M. 2004. Defining the balance of risk and benefit in the era of genomics and pro- teomics. Health Aff (Millwood) 23(1):77-87. Califf, R. M., and G. S. Ginsburg. 2008. Organizational improvements to enhance modern clinical epidemiology. JAMA 300(19):2300-2302. Califf, R. M., E. D. Peterson, R. J. Gibbons, A. Garson, Jr., R. G. Brindis, G. A. Beller, and S. C. Smith, Jr. 2002. Integrating quality into the cycle of therapeutic development. J Am Coll Cardiol 40(11):1895-1901. CDC (Centers for Disease Control and Prevention). 2007. ACCE: A CDC-sponsored project carried out by the foundation of blood research. http://cdc.gov/genomics/gtesting/ACCE. htm (accessed June 1, 2009). Davis, R. L., and M. J. Khoury. 2006. A public health approach to pharmacogenomics and gene-based diagnostic tests. Pharmacogenomics 7(3):331-337. Djulbegovic, B., and B. Bercu. 2002. At what level of collective equipoise does a clinical trial become ethical for the IRB members? Paper presented at USF Third National Sympo- sium, Bioethical Considerations in Human Subject Research, Clearwater, FL. March 8. Djulbegovic, B., A. Frohlich, and C. L. Bennett. 2005. Acting on imperfect evidence: How much regret are we ready to accept? J Clin Oncol 23(28):6822-6825. EGAPP (Evaluation of Genomic Applications in Practice and Prevention). 2009. Working group: Recommendations. http://www.egappreviews.org/workingrp/recommendations. htm (accessed May 27, 2009). Ginsburg, G. S. 2009. Duke guided genomic studies. Presentation at Institute of Medicine workshop, Systems for Research and Evaluation for Translating Genome-Based Dis­ coveries for Health, Irvine, CA. February 12. 69

70 SYSTEMS FOR RESEARCH AND EVALUATION Ginsburg, G. S., and J. J. McCarthy. 2001. Personalized medicine: Revolutionizing drug dis- covery and patient care. Trends Biotechnol 19(12):491-496. Goldstein, D. B. 2009. Common Genetic Variation and Human Traits. N Engl J Med 360(17): 1696-1698. Grosse, S. D., and M. J. Khoury. 2006. What is the clinical utility of genetic testing? Genet Med 8(7):448-450. Gudgeon, J. M., M. R. McClain, G. E. Palomaki, and M. S. Williams. 2007. Rapid ACCE: Experience with a rapid and structured approach for evaluating gene-based testing. Genet Med 9(7):473-478. Haddow, J. E., and G. E. Palomaki. 2004. ACCE: A model process for evaluating data on emerging genetic tests. In Human genome epidemiology: A scientific foundation for using genetic information to improve health and prevent disease, edited by M. J. Khoury, J. Little, and W. Burke. New York: Oxford University Press. Pp. 217-233. Hardy, J., and A. Singleton. 2009. Genome Wide Association Studies and Human Disease. N Engl J Med 360(17):1759-1768. IOM (Institute of Medicine). 2006. Genes, Behavior, and the Social Environment: Moving Beyond the Nature/Nurture Debate. Washington, DC: The National Academies Press. ———. 2008. Diffusion and Use of Genomic Innovations in Health and Medicine. Washing- ton, DC: The National Academies Press. ———. 2009. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington, DC: The National Academies Press. Kaufman, D., J. Murphy, L. Erby, K. Hudson, and J. Scott. 2009. Veterans’ attitudes regarding a database for genomic research. Genet Med 11(5):329-337. Khoury, M. J., A. Berg, R. Coates, J. Evans, S. M. Teutsch, and L. A. Bradley. 2008. The evidence dilemma in genomic medicine. Health Aff (Millwood) 27(6):1600-1611. Mallal, S., E. Phillips, G. Carosi, J. M. Molina, C. Workman, J. Tomazic, E. Jagel-Guedes, S. Rugina, O. Kozyrev, J. F. Cid, P. Hay, D. Nolan, S. Hughes, A. Hughes, S. Ryan, N. Fitch, D. Thorborn, and A. Benbow. 2008. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med 358(6):568-579. Muralidhar, S. 2009. Veterans administration. Presentation at Institute of Medicine workshop, Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health, Irvine, CA. February 12. Phillips, K. A. 2006. The intersection of biotechnology and pharmacogenomics: Health policy implications. Health Aff (Millwood) 25(5):1271-1280. ———. 2008. Closing the evidence gap in the use of emerging testing technologies in clinical practice. JAMA 300(21):2542-2544. Potti, A., S. Mukherjee, R. Petersen, H. K. Dressman, A. Bild, J. Koontz, R. Kratzke, M. A. Watson, M. Kelley, G. S. Ginsburg, M. West, D. H. Harpole, Jr., and J. R. Nevins. 2006. A genomic strategy to refine prognosis in early-stage non-small-cell lung cancer. N Engl J Med 355(6):570-580. Smith, D. J., and A. J. Lusis. 2009. Genomic Approaches to Complex Disease. Genomic and Personalized Medicine, edited by H. F. Willard and G. S. Ginsburg. Oxford, UK: Elsevier, Inc. Tavris, D. R., B. A. Gallauresi, S. Dey, R. Brindis, and K. Mitchel. 2007. Risk of local ad- verse events by gender following cardiac catheterization. Pharmacoepidemiol Drug Saf 16(2):125-131. Teutsch, S. M. 2009, February 12. Does the type of decision being made influence the evidence needed? Presentation at Institute of Medicine workshop, Systems for Research and Evalu- ation for Translating Genome-Based Discoveries for Health, Irvine, CA, February 12. Teutsch, S. M., and M. L. Berger. 2005. Evidence synthesis and evidence-based decision mak- ing: Related but distinct processes. Med Decis Making 25(5):487-489.

REFERENCES 71 Teutsch, S. M., L. A. Bradley, G. E. Palomaki, J. E. Haddow, M. Piper, N. Calonge, W. D. Dotson, M. P. Douglas, and A. O. Berg. 2009. The evaluation of genomic applications in practice and prevention (EGAPP) initiative: Methods of the EGAPP working group. Genet Med 11(1):3-14. Williams, M., and G. Wood. 2009. Estimating the prevalence of hereditary hemorrhagic telangiectasia (HHT) in patients with juvenile polyposis (JP) using a clinical informatics system. J Investig Med 57(116):A68.

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With the advent of genome-wide association studies, numerous associations between specific gene loci and complex diseases have been identified—for breast cancer, coronary artery disease, and asthma, for example. This rapidly advancing field of genomics has stirred great interest in "personalized" health care from both the public and private sectors. The hope is that using genomic information in clinical care will lead to reduced health care costs and improved health outcomes as therapies are tailored to the genetic susceptibilities of patients.

A variety of genetically based health care innovations have already reached the marketplace, but information about the clinical use of these treatments and diagnostics is limited. Currently data do not provide information about how a genomic test impacts clinical care and patient health outcomes—other approaches are needed to garner such information.

This volume summarizes a workshop to address central questions related to the development of systems to evaluate clinical use of health care innovations that stem from genome-based research:

What are the practical realities of creating such systems?

What different models could be used?

What are the strengths and weaknesses of each model?

How effectively can such systems address questions about health outcomes?

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