NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Institute of Medicine (US). Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing An Agenda for 2020: Workshop Summary. Washington (DC): National Academies Press (US); 2012.

Cover of Envisioning a Transformed Clinical Trials Enterprise in the United States

Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing An Agenda for 2020: Workshop Summary.

Show details

References

  • Adams CP, Brantner VV. Estimating the cost of new drug development: Is it really $802 million? Health Affairs. 2006;25(2):420–428. [accessed January 31, 2012]; http://content​.healthaffairs​.org/content/25/2/420.full.html. [PubMed: 16522582]
  • AHRQ (Agency for Healthcare Research and Quality). AHRQ at a glance. 2011. [accessed November 11, 2011]. http://www​.ahrq.gov/about/ataglance.htm.
  • Bonham AC, Califf RM, Gallin EK, Lauer MS. Developing a robust clinical trials workforce. Institute of Medicine; Washington, DC: 2012. Discussion Paper.
  • Califf RM, Filerman GL, Murray RK, Rosenblatt M. The clinical trials enterprise in the United States: A call for disruptive innovation. Institute of Medicine; Washington, DC: 2012. Discussion Paper.
  • CenterWatch. Proposed Common Rule updates focus on consent, definitions, streamlined IRB review, data protection. Oct 31, 2011. [accessed January 11, 2012]. http://centerwatch​.com​/news-online/article​/2443/proposed-common-rule-updates-focus-on-consent-definitions-streamlined-irb-review-data-protection.
  • CERN (European Organization for Nuclear Research). ATLAS and CMS experiments present Higgs search status. 2011. [accessed December 18, 2011]. http://public​.web.cern.ch/public/
  • DeVol RC, Bedroussian A, Yeo B. The global biomedical industry: Preserving US leadership. 2011. [accessed February 9, 2012]. http://www​.milkeninstitute​.org/pdf/CASMIFullReport.pdf.
  • Deyell MW, Buller CE, Miller LH, Wang TY, Dai D, Lamas GA, Srinivas VS, Hochman JS. 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. 2011;171(18):1636–1643. [PMC free article: PMC3738051] [PubMed: 21747002]
  • Dzau VJ, Ackerly DC, Sutton-Wallace P, Merson MH, Williams RS, Krishnan KR, Taber RC, Califf RM. The role of academic health science systems in the transformation of medicine. Lancet. 2010;375:949–953. [PubMed: 19800111]
  • Eisenberg P, Kaufmann P, Sigal EV, Woodcock J. Developing a clinical trials infrastructure. Institute of Medicine; Washington, DC: 2012. Discussion Paper.
  • Executive Office of the President, President’s Council of Advisors on Science and Technology. Realizing the full potential of health information technology to improve healthcare for Americans: The path forward. Washington, DC: The White House; 2010. [accessed November 10, 2011]. Report to the President. http://www​.whitehouse​.gov/sites/default/files​/microsites/ostp​/pcast-health-it-report.pdf.
  • FDA (Food and Drug Administration). Advancing regulatory science for public health. 2010. [accessed January 23, 2012]. http://www​.fda.gov/ScienceResearch​/SpecialTopics​/RegulatoryScience/ucm228131.htm.
  • Gallin JI. 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, 2011; Washington, DC.
  • HHS (Department of Health and Human Services). Advanced Notice of Proposed Rulemaking: Human subjects protections update. 2011. [accessed December 12, 2011]. http://www​.hhs.gov/ohrp​/humansubjects/index.html.
  • Hochman JS, Lamas GA, Buller CE, Dzavik V, Reynolds HR, Abramsky SJ, Forman S, Ruzyllo W, Maggioni AP, White H, Sadowski Z, Carvalho AC, Rankin JM, Renkin JP, Steg PG, Mascette AM, Sopko G, Pfisterer ME, Leor J, Fridrich V, Mark DB, Knatterud GL. Coronary intervention for persistent occlusion after myocardial infarction. New England Journal of Medicine. 2006;355(23):2395–2407. [PMC free article: PMC1995554] [PubMed: 17105759]
  • i2b2. Informatics for integrating biology and the bedside; 2011. [accessed December 2, 2011]. https://www​.i2b2.org/
  • IOM (Institute of Medicine). Crossing the quality chasm: A new health system for the 21st century. Washington, DC: National Academy Press; 2001.
  • IOM. Health literacy: A prescription to end confusion. Washington, DC: The National Academies Press; 2004.
  • IOM. The learning healthcare system Workshop summary. Washington, DC: The National Academies Press; 2007.
  • IOM. Initial national priorities for comparative effectiveness research. Washington, DC: The National Academies Press; 2009.
  • IOM. Transforming clinical research in the United States: Challenges and opportunities Workshop summary. Washington, DC: The National Academies Press; 2010.
  • IOM. The healthcare imperative: Lowering costs and improving outcomes. Workshop summary. Washington, DC: The National Academies Press; 2010. [PubMed: 21595114]
  • IOM. Engineering a learning healthcare system: A look at the future Workshop summary. Washington, DC: The National Academies Press; 2011. [PubMed: 21977540]
  • IOM. Learning what works: Infrastructure required for comparative effectiveness research Workshop summary. Washington, DC: The National Academies Press; 2011. [PubMed: 22013609]
  • IOM. Innovations in health literacy research Workshop summary. Washington, DC: The National Academies Press; 2011.
  • IOM. Public engagement and clinical trials: New models and disruptive technologies. Workshop summary. Washington, DC: The National Academies Press; 2012. [PubMed: 22514814]
  • IOM. Strengthening a workforce for innovative regulatory science in therapeutics development. Workshop summary. Washington, DC: The National Academies Press; 2012. [PubMed: 22593951]
  • Jolly MK. 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 JM. Oregon’s test of value-based insurance design in coverage for state workers. Health Affairs. 2010;29(11):2028–2032. [PubMed: 21041744]
  • Kocher R, Sahni NR. Rethinking health care labor. New England Journal of Medicine. 2011;365(15):1370–1372. [PubMed: 21995383]
  • Kolodziej MA. The community oncologist: Part of the solution. Journal of the National Comprehensive Cancer Network. 2011;9:345–347. [PubMed: 21464143]
  • Kost RG, Lee LM, Yessis J, Coller BS, Henderson DK. The Research Participant Perception Survey Focus Group Subcommittee. Assessing research participants’ perceptions of their clinical research experiences. Clinical and Translational Science. 2011;4(6):403–413. [PMC free article: PMC3640854] [PubMed: 22212221]
  • Kramer JM, Schulman KA. 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, 2011; Washington, DC.
  • Kramer JM, Schulman KA. Transforming the economics of clinical trials. Institute of Medicine; Washington, DC: 2012. Discussion Paper.
  • Law MR, Kawasumi Y, Morgan SG. Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on clinicaltrials.gov. Health Affairs. 2011;30(12):2338–2345. [PubMed: 22147862]
  • Lee DH, Vielemeyer O. Analysis of overall level of evidence behind Infectious Disease Society of America practice guidelines. Annals of Internal Medicine. 2011;171:18–22. [PubMed: 21220656]
  • Lilford RJ, Jackson J. Equipoise and the ethics of randomization. Journal of the Royal Society of Medicine. 1995;88:552–559. [PMC free article: PMC1295354] [PubMed: 8537943]
  • Mackenzie IS, Wei L, Rutherford D, Findlay EA, Saywood W, Campbell MK, MacDonald TM. Promoting public awareness of randomised clinical trials using the media: The “Get Randomised” campaign. Journal of Clinical Pharmacology. 2010;69(2):128–135. [PMC free article: PMC2817445] [PubMed: 20233175]
  • Mansell P. Pfizer announces “virtual” clinical trial pilot in U.S. PharmaTimes. Jun 9, 2011. [accessed December 8, 2011]. http://www​.pharmatimes​.com/Article/11-06-09​/Pfizer_announces​_virtual_clinical_trial_pilot_in_US.aspx.
  • National Marfan Foundation. Atenolol versus losartan clinical trial. 2011. [accessed December 5, 2011]. http://www​.marfan.org​/marfan/2408/Atenolol-vs​.-Losartan-Clinical-Trial.
  • NIH (National Institutes of Health), Division of Program Coordination, Planning and Strategic Initiatives. The NIH Common Fund. 2011. [accessed November 18, 2011]. http://commonfund​.nih​.gov/researchteams/index.aspx.
  • NIH, Scientific Management Review Board. Report on the NIH Clinical Center. 2010. [accessed April 10, 2012]. http://smrb​.od.nih.gov/
  • O’Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, Heizer GM, Komajda M, Massie BM, McMurray JJV, Nieminen MS, Reist CJ, Rouleau JL, Swedberg K, Adams KF, Anker SD, Atar D, Battler A, Botero R, Bohidar NR, Butler J, Clausell N, Corbalán R, Costanzo MR, Dahlstrom U, Deckelbaum LI, Diaz R, Dunlap ME, Ezekowitz JA, Feldman D, Felker GM, Fonarow GC, Gennevois D, Gottlieb SS, Hill JA, Hollander JE, Howlett JG, Hudson MP, Kociol RD, Krum H, Laucevicius A, Levy WC, Méndez GF, Metra M, Mittal S, Oh B-H, Pereira NL, Ponikowski P, Tang WHW, Tanomsup S, Teerlink JR, Triposkiadis F, Troughton RW, Voors AA, Whellan DJ, Zannad F, Califf RM. Effect of nesiritide in patients with acute decompensated heart failure. New England Journal of Medicine. 2011;365(1):32–43. [PubMed: 21732835]
  • Platt R, Takvorian SU, Septimus E, Hickok J, Moody J, Perlin J, Jernigan JA, Kleinman K, Huang SS. Cluster randomized trials in comparative effectiveness research: Randomizing hospitals to test methods for prevention of healthcare-associated infections. Medical Care. 2010;48(6):S52–S57. [PubMed: 20473200]
  • Platt R, Carnahan RM, Brown JS, Chrischilles E, Curtis LH, Hennessy S, Nelson JC, Racoosin JA, Robb M, Schneeweiss S, Toh S, Weiner MG. The U.S. Food and Drug Administration’s Mini-Sentinel program: Status and direction. Pharmacoepidemiology and Drug Safety. 2012;21(S1):1–8. [PubMed: 22262586]
  • Pollack A. FDA approves drug for lupus, an innovation after 50 years. New York Times. Mar 9, 2011. [accessed December 4, 2011]. http://www​.nytimes.com​/2011/03/10/health/10drug.html.
  • Ramsey BW, Davies J, McElvaney NG, Tullis E, Bell SC, Drevinek P, Griese M, McKone EF, Wainwright CE, Konstan MW, Moss R, Ratjen F, Sermet-Gaudelus I, Rowe SM, Dong Q, Rodriguez S, Yen K, Ordonez C, Elborn JS. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. New England Journal of Medicine. 2011;365(18):1663–1672. [PMC free article: PMC3230303] [PubMed: 22047557]
  • Research!America. Americans expect medical breakthroughs. 2007. [accessed December 4, 2011]. http://www​.researchamerica​.org/uploads/poll​.report.2007.transforminghealth.pdf.
  • Rudd RE, Anderson JE, Oppenheimer S, Nath C. Health literacy: An update of public health and medical literature. In: Comings JP, Garner B, Smith C, editors. Review of Adult Learning and Literacy. Vol. 7. Mahwah, NJ: Lawrence Erlbaum Associates; 2007. pp. 175–204.
  • Schaefer GO, Emanuel EJ, Wertheimer A. The obligation to participate in biomedical research. Journal of the American Medical Association. 2009;302(1):67–72. [PMC free article: PMC2763192] [PubMed: 19567441]
  • Sung NS, Crowley WF, Genel M, Salber P, Sandy L, Sherwood LM, Johnson SB, Catanese V, Tilson H, Getz K, Larson EL, Scheinberg D, Reece EA, Slavkin H, Dobs A, Grebb J, Martinez RA, Korn A, Rimoin D. Central challenges facing the national clinical research enterprise. Journal of the American Medical Association. 2003;289(10):1278–1287. [PubMed: 12633190]
  • Topol EJ. Nesiritide—not verified. New England Journal of Medicine. 2005;353(2):113–116. [PubMed: 16014879]
  • Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC Jr. Scientific evidence underlying the ACC/AHA clinical practice guidelines. Journal of the American Medical Association. 2009;301:967–974. [PubMed: 19244190]
  • Tufts Center for the Study of Drug Development. Impact report: Notable gender and racial disparities exist among clinical investigators. November/December, 2007. [accessed January 23, 2011]. http://csdd​.tufts.edu​/files/uploads/08_-_nov​._5,_2007_-_principal_investigators​.pdf.
  • Varmus H, Harlow E. Provocative questions in cancer research. Nature. 2012;481:436–437. [accessed January 30, 2012]; http://www​.nature.com​/nature/journal/v481​/n7382/full/481436a.html. [PubMed: 22281578]
  • Vastag B, Achenbach J. Scientists close in on linchpin of physics, the “God particle” Washington Post. Dec 12, 2011. [accessed December 18, 2011]. http://www​.washingtonpost​.com/national/health-science​/scientists-close-in-on-linchpin-of-physics-the-god-particle​/2011/12​/12/gIQAmk2cqO_story.html.
  • Vincent GK, Velkoff VA. Current Population Reports. Washington, DC: U.S. Census Bureau; 2010. The next four decades: The older population in the United States: 2010 to 2050.
  • Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. New England Journal of Medicine. 2009;361(11):1045–1057. [PubMed: 19717846]
  • Wood A. 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, 2011; Washington, DC.
  • Yu P. 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.
Copyright © 2012, National Academy of Sciences.
Bookshelf ID: NBK114663

Views

Related information

  • PMC
    PubMed Central citations
  • PubMed
    Links to PubMed

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...