National Academies Press: OpenBook
« Previous: 6 Suggesting an Agenda for Transforming Elements of the Clinical Trials Enterprise
Suggested Citation:"References." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

References

Adams, C. P., and V. V. Brantner. 2006. Estimating the cost of new drug development: Is it really $802 million? Health Affairs 25(2):420-428. http://content.healthaffairs.org/content/25/2/420.full.html (accessed January 31, 2012).

AHRQ (Agency for Healthcare Research and Quality). 2011. AHRQ at a glance. http://www.ahrq.gov/about/ataglance.htm (accessed November 11, 2011).

Bonham, A. C., R. M. Califf, E. K. Gallin, and M. S. Lauer. 2012. Developing a robust clinical trials workforce. Discussion Paper, Institute of Medicine, Washington, DC.

Califf, R. M., G. L. Filerman, R. K. Murray, and M. Rosenblatt. 2012. The clinical trials enterprise in the United States: A call for disruptive innovation. Discussion Paper, Institute of Medicine, Washington, DC.

CenterWatch. 2011. Proposed Common Rule updates focus on consent, definitions, streamlined IRB review, data protection. October 31. http://centerwatch.com/news-online/article/2443/proposed-common-rule-updates-focus-on-consent-definitions-streamlined-irb-review-data-protection (accessed January 11, 2012).

CERN (European Organization for Nuclear Research). 2011. ATLAS and CMS experiments present Higgs search status. http://public.web.cern.ch/public/ (accessed December 18, 2011).

DeVol, R. C., A. Bedroussian, and B. Yeo. 2011. The global biomedical industry: Preserving U.S. leadership. http://www.milkeninstitute.org/pdf/CASMIFullReport.pdf (accessed February 9, 2012).

Deyell, M.W., C. E. Buller, L. H. Miller, T. Y. Wang, D. Dai, G. A. Lamas, V. S. Srinivas, and J. S. Hochman. 2011. Impact of National Clinical Guideline recommendations for revascularization of persistently occluded infarct-related arteries on clinical practice in the United States. Archives of Internal Medicine 171(18):1636-1643.

Dzau, V. J., D. C. Ackerly P. Sutton-Wallace, M. H. Merson, R. S. Williams, K. R. Krishnan, R. C. Taber, and R. M. Califf. 2010. The role of academic health science systems in the transformation of medicine. Lancet 375:949-953.

Eisenberg, P., P. Kaufmann, E. V. Sigal, and J. Woodcock. 2012. Developing a clinical trials infrastructure. Discussion Paper, Institute of Medicine, Washington, DC.

Suggested Citation:"References." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

Executive Office of the President, President’s Council of Advisors on Science and Technology. 2010. Realizing the full potential of health information technology to improve healthcare for Americans: The path forward. Report to the President. Washington, DC: The White House. http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-health-it-report.pdf ( accessed November 10, 2011).

FDA (Food and Drug Administration). 2010. Advancing regulatory science for public health. http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm228131.htm (accessed January 23, 2012).

Gallin, J. I. 2011. Sustaining institutional support and patient engagement in clinical trials: Models and messages from the NIH Clinical Center. Speaker presentation at the IOM Workshop on Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020, November 7, Washington, DC.

HHS (Department of Health and Human Services). 2011. Advanced Notice of Proposed Rule-making: Human subjects protections update. http://www.hhs.gov/ohrp/humansubjects/index.html (accessed December 12, 2011).

Hochman, J. S., G. A. Lamas, C. E. Buller, V. Dzavik, H. R. Reynolds, S. J. Abramsky, S. Forman, W. Ruzyllo, A. P. Maggioni, H. White, Z. Sadowski, A. C. Carvalho, J. M. Rankin, J. P. Renkin, P. G. Steg, A. M. Mascette, G. Sopko, M. E. Pfisterer, J. Leor, V. Fridrich, D. B. Mark, and G. L. Knatterud. 2006. Coronary intervention for persistent occlusion after myocardial infarction. New England Journal of Medicine 355(23):2395-2407. i2b2. 2011. Informatics for integrating biology and the bedside. https://www.i2b2.org/ (accessed December 2, 2011).

IOM (Institute of Medicine). 2001. Crossing the quality chasm: A new health system for the 21st century. Washington, DC: National Academy Press.

IOM. 2004. Health literacy: A prescription to end confusion. Washington, DC: The National Academies Press.

IOM. 2007. The learning healthcare system. Workshop summary. Washington, DC: The National Academies Press.

IOM. 2009. Initial national priorities for comparative effectiveness research. Washington, DC: The National Academies Press.

IOM. 2010a. Transforming clinical research in the United States: Challenges and opportunities. Workshop summary. Washington, DC: The National Academies Press.

IOM. 2010b. The healthcare imperative: Lowering costs and improving outcomes. Workshop summary. Washington, DC: The National Academies Press.

IOM. 2011a. Engineering a learning healthcare system: A look at the future. Workshop summary. Washington, DC: The National Academies Press.

IOM. 2011b. Learning what works: Infrastructure required for comparative effectiveness research. Workshop summary. Washington, DC: The National Academies Press.

IOM. 2011c. Innovations in health literacy research. Workshop summary. Washington, DC: The National Academies Press.

IOM. 2012a. Public engagement and clinical trials: New models and disruptive technologies. Workshop summary. Washington, DC: The National Academies Press.

IOM. 2012b. Strengthening a workforce for innovative regulatory science in therapeutics development. Workshop summary. Washington, DC: The National Academies Press.

Jolly, M. K. 2011. PACeR: The Partnership to Accelerate Clinical electronic Research—improves predictive success. Speaker presentation at the IOM workshop on Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020, November 8, 2011, Washington, DC.

Kapowich, J. M. 2010. Oregon’s test of value-based insurance design in coverage for state workers. Health Affairs 29(11):2028-2032.

Kocher, R., and N. R. Sahni. 2011. Rethinking health care labor. New England Journal of Medicine 365(15):1370-1372.

Suggested Citation:"References." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

Kolodziej, M. A. 2011. The community oncologist: Part of the solution. Journal of the National Comprehensive Cancer Network 9:345-347.

Kost, R. G., L. M. Lee, J. Yessis, B. S. Coller, D. K. Henderson, and The Research Participant Perception Survey Focus Group Subcommittee. 2011. Assessing research participants’ perceptions of their clinical research experiences. Clinical and Translational Science 4(6):403-413.

Kramer, J. M., and K. A. Schulman. 2011. Transforming the economics of clinical trials. Speaker presentation at the Institute of Medicine Workshop on Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020, November 7-8, Washington, DC.

Kramer, J. M., and K. A. Schulman. 2012. Transforming the economics of clinical trials. Discussion Paper, Institute of Medicine, Washington, DC.

Law, M. R., Y. Kawasumi, and S. G. Morgan. 2011. Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on clinicaltrials.gov. Health Affairs 30(12):2338-2345.

Lee, D. H., and O. Vielemeyer. 2011. Analysis of overall level of evidence behind Infectious Disease Society of America practice guidelines. Annals of Internal Medicine 171:18-22.

Lilford, R. J., and J. Jackson. 1995. Equipoise and the ethics of randomization. Journal of the Royal Society of Medicine 88:552-559.

Mackenzie, I. S., L. Wei, D. Rutherford, E. A. Findlay, W. Saywood, M. K. Campbell, and T. M. MacDonald. 2010. Promoting public awareness of randomised clinical trials using the media: The “Get Randomised” campaign. Journal of Clinical Pharmacology 69(2):128-135.

Mansell, P. 2011. Pfizer announces “virtual” clinical trial pilot in U.S. PharmaTimes, June 9. http://www.pharmatimes.com/Article/11-06-09/Pfizer_announces_virtual_clinical_trial_pilot_in_US.aspx (accessed December 8, 2011).

National Marfan Foundation. 2011. Atenolol versus losartan clinical trial. http://www.marfan.org/marfan/2408/Atenolol-vs.-Losartan-Clinical-Trial (accessed December 5, 2011).

NIH (National Institutes of Health), Division of Program Coordination, Planning and Strategic Initiatives. 2011. The NIH Common Fund. http://commonfund.nih.gov/researchteams/index.aspx (accessed November 18, 2011).

NIH, Scientific Management Review Board. 2010. Report on the NIH Clinical Center. smrb.od.nih.gov/ (accessed April 10, 2012).

O’Connor, C. M., R. C. Starling, A. F. Hernandez, P. W. Armstrong, K. Dickstein, V. Hasselblad, G. M. Heizer, M. Komajda, B. M. Massie, J. J. V. McMurray, M. S. Nieminen, C. J. Reist, J. L. Rouleau, K. Swedberg, K. F. Adams, S. D. Anker, D. Atar, A. Battler, R. Botero, N. R. Bohidar, J. Butler, N. Clausell, R. Corbalán, M. R. Costanzo, U. Dahlstrom, L. I. Deckelbaum, R. Diaz, M. E. Dunlap, J. A. Ezekowitz, D. Feldman, G. M. Felker, G. C. Fonarow, D. Gennevois, S. S. Gottlieb, J. A. Hill, J. E. Hollander, J. G. Howlett, M. P. Hudson, R. D. Kociol, H. Krum, A. Laucevicius, W. C. Levy, G. F. Méndez, M. Metra, S. Mittal, B.-H. Oh, N. L. Pereira, P. Ponikowski, W. H. W. Tang, S. Tanomsup, J. R. Teerlink, F. Triposkiadis, R. W. Troughton, A. A. Voors, D. J. Whellan, F. Zannad, and R. M. Califf. 2011. Effect of nesiritide in patients with acute decompensated heart failure. New England Journal of Medicine 365(1):32-43.

Platt, R., Takvorian S.U., Septimus E., Hickok J., Moody J., Perlin J., Jernigan J. A., Kleinman K., Huang S. S. 2010. Cluster randomized trials in comparative effectiveness research: Randomizing hospitals to test methods for prevention of healthcare-associated infections. Medical Care 48(6):S52-S57.

Platt, R., R. M. Carnahan, J. S. Brown, E. Chrischilles, L. H. Curtis, S. Hennessy, J. C. Nelson, J. A. Racoosin, M. Robb, S. Schneeweiss, S. Toh, and M. G. Weiner. 2012. The U.S. Food and Drug Administration’s Mini-Sentinel program: Status and direction. Pharmacoepidemiology and Drug Safety 21(S1):1-8.

Suggested Citation:"References." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×

Pollack, A. 2011. FDA approves drug for lupus, an innovation after 50 years. New York Times, March 9. http://www.nytimes.com/2011/03/10/health/10drug.html (accessed December 4, 2011).

Ramsey, B. W., J. Davies, N. G. McElvaney, E. Tullis, S. C. Bell, P. Drevinek, M. Griese, E. F. McKone, C. E. Wainwright, M. W. Konstan, R. Moss, F. Ratjen, I. Sermet-Gaudelus, S. M. Rowe, Q. Dong, S. Rodriguez, K. Yen, C. Ordonez, and J. S. Elborn. 2011. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. New England Journal of Medicine 365(18):1663-1672.

Research!America. 2007. Americans expect medical breakthroughs. http://www.researchamerica.org/uploads/poll.report.2007.transforminghealth.pdf (accessed December 4, 2011).

Rudd, R. E., J. E. Anderson, S. Oppenheimer, and C. Nath. 2007. Health literacy: An update of public health and medical literature. In Review of Adult Learning and Literacy, Vol. 7, edited by J. P. Comings, B. Garner, and C. Smith. Mahwah, NJ: Lawrence Erlbaum Associates. Pp. 175-204.

Schaefer, G. O., E. J. Emanuel, and A. Wertheimer. 2009. The obligation to participate in biomedical research. Journal of the American Medical Association 302(1):67-72.

Sung, N. S., W. F. Crowley, M. Genel, P. Salber, L. Sandy, L. M. Sherwood, S. B. Johnson, V. Catanese, H. Tilson, K. Getz, E. L. Larson, D. Scheinberg, E. A. Reece, H. Slavkin, A. Dobs, J. Grebb, R. A. Martinez, A. Korn, and D. Rimoin. 2003. Central challenges facing the national clinical research enterprise. Journal of the American Medical Association 289(10):1278-1287.

Topol, E.J. 2005. Nesiritide—not verified. New England Journal of Medicine 353(2):113-116.

Tricoci, P., J. M. Allen, J. M. Kramer, R. M. Califf, and S. C. Smith, Jr. 2009. Scientific evidence underlying the ACC/AHA clinical practice guidelines. Journal of the American Medical Association 301:967-974.

Tufts Center for the Study of Drug Development. 2007. Impact report: Notable gender and racial disparities exist among clinical investigators. November/December, 9(6). http://csdd.tufts.edu/files/uploads/08_-_nov._5,_2007_-_principal_investigators.pdf (accessed January 23, 2011).

Varmus, H. and E. Harlow. 2012. Provocative questions in cancer research. Nature 481:436-437. http://www.nature.com/nature/journal/v481/n7382/full/481436a.html (accessed January 30, 2012).

Vastag, B., and J. Achenbach. 2011. Scientists close in on linchpin of physics, the “God particle.” Washington Post, December 12. http://www.washingtonpost.com/national/health-science/scientists-close-in-on-linchpin-of-physics-the-god-particle/2011/12/12/gIQAmk2cqO_story.html (accessed December 18, 2011).

Vincent, G. K., and V. A. Velkoff. 2010. The next four decades: The older population in the United States: 2010 to 2050. Current Population Reports. Washington, DC: U.S. Census Bureau.

Wallentin, L., R. C. Becker, A. Budaj, C. P. Cannon, H. Emanuelsson, C. Held, J. Horrow, S. Husted, S. James, H. Katus, K. W. Mahaffey, B. M. Scirica, A. Skene, P. G. Steg, R. F. Storey, and R. A. Harrington. 2009. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. New England Journal of Medicine 361(11):1045-1057.

Wood, A. 2011. Envisioning CTE in the health care system of 2020. Speaker presentation at the Institute of Medicine Workshop on Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020, November 7-8, Washington, DC.

Yu, P. 2011. The learning health system. Speaker presentation at the IOM workshop on Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020, November 7, 2011, Washington, DC.

Suggested Citation:"References." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 81
Suggested Citation:"References." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 82
Suggested Citation:"References." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 83
Suggested Citation:"References." Institute of Medicine. 2012. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13345.
×
Page 84
Next: Appendix A: Workshop Agenda »
Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary Get This Book
×
Buy Paperback | $49.00 Buy Ebook | $39.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions.


With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!