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Volumn 9, Issue 4, 2012, Pages 436-446

The role for pragmatic randomized controlled trials (pRCTs) in comparative effectiveness research

Author keywords

[No Author keywords available]

Indexed keywords

SPIRONOLACTONE;

EID: 84865497470     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774512450097     Document Type: Review
Times cited : (135)

References (75)
  • 1
    • 61449263596 scopus 로고    scopus 로고
    • Scientific evidence underlying the ACC/AHA clinical practice guidelines
    • Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA. 2009 ; 301 (8). 831-41
    • (2009) JAMA , vol.301 , Issue.8 , pp. 831-841
    • Tricoci, P.1    Allen, J.M.2    Kramer, J.M.3    Califf, R.M.4    Smith, S.C.5
  • 2
    • 0042991391 scopus 로고    scopus 로고
    • Most hospitalized older persons do not meet the enrolment criteria for clinical trials in heart failure
    • Masoudi FA, Havranek EP, Wolfe P. Most hospitalized older persons do not meet the enrolment criteria for clinical trials in heart failure. et al Am Heart J. 2003 ; 146: 250-57
    • (2003) Et Al Am Heart J , vol.146 , pp. 250-257
    • Masoudi, F.A.1    Havranek, E.P.2    Wolfe, P.3
  • 3
    • 33947579183 scopus 로고    scopus 로고
    • External validity of randomised controlled trials in asthma: To whom do the results of the trials apply?
    • Travers J, Marsh S, Williams M. External validity of randomised controlled trials in asthma: To whom do the results of the trials apply?. et al Thorax. 2007 ; 62: 219-23
    • (2007) Et Al Thorax , vol.62 , pp. 219-223
    • Travers, J.1    Marsh, S.2    Williams, M.3
  • 4
    • 68249103874 scopus 로고    scopus 로고
    • Comparative effectiveness research. A report from the Institute of Medicine
    • Sox HC, Greenfield S. Comparative effectiveness research. A report from the Institute of Medicine. Ann Intern Med. 2009 ; 151: 203-05
    • (2009) Ann Intern Med , vol.151 , pp. 203-205
    • Sox, H.C.1    Greenfield, S.2
  • 5
    • 77951719379 scopus 로고    scopus 로고
    • Comparative effectiveness research: Challenges for medical journals
    • Sox H, Helfand M, Grimshaw J. Comparative effectiveness research: Challenges for medical journals. et al PLoS Med. 2010 ; 6: e1000269
    • (2010) Et Al PLoS Med , vol.6 , pp. 1000269
    • Sox, H.1    Helfand, M.2    Grimshaw, J.3
  • 6
    • 84872829355 scopus 로고    scopus 로고
    • Patient Centered Outcomes Research Institute (accessed 26 May 2011)
    • Patient Centered Outcomes Research Institute. About PCORI. Available at: http://www.pcori.org/ (accessed 26 May 2011).
    • About PCORI
  • 7
    • 0031050969 scopus 로고    scopus 로고
    • Pragmatic and mechanistic trials
    • Califf RM, Woodlief LH. Pragmatic and mechanistic trials. Eur Heart J. 1997 ; 18: 367-70
    • (1997) Eur Heart J , vol.18 , pp. 367-370
    • Califf, R.M.1    Woodlief, L.H.2
  • 8
    • 0032561943 scopus 로고    scopus 로고
    • What are pragmatic trials?
    • Roland M, Torgerson DJ. What are pragmatic trials?. BMJ. 1998 ; 316: 285
    • (1998) BMJ , vol.316 , pp. 285
    • Roland, M.1    Torgerson, D.J.2
  • 9
    • 79955736485 scopus 로고    scopus 로고
    • Pragmatic trials-guides to better patient care?
    • Ware JH, Hamel MB. Pragmatic trials-guides to better patient care?. N Engl J Med. 2011 ; 364: 1685-87
    • (2011) N Engl J Med , vol.364 , pp. 1685-1687
    • Ware, J.H.1    Hamel, M.B.2
  • 10
    • 0141684982 scopus 로고    scopus 로고
    • Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy
    • Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003 ; 290: 1624-32
    • (2003) JAMA , vol.290 , pp. 1624-1632
    • Tunis, S.R.1    Stryer, D.B.2    Clancy, C.M.3
  • 11
    • 20544473255 scopus 로고    scopus 로고
    • Practical clinical trials for translating research to practice: Design and measurement recommendations
    • Glasgow RE, Magid DJ, Beck A, Ritzwoller D, Estabrooks PA. Practical clinical trials for translating research to practice: Design and measurement recommendations. Med Care. 2005 ; 43: 551-57
    • (2005) Med Care , vol.43 , pp. 551-557
    • Glasgow, R.E.1    Magid, D.J.2    Beck, A.3    Ritzwoller, D.4    Estabrooks, P.A.5
  • 12
    • 0028831227 scopus 로고
    • Large-scale randomized evidence: Large, simple trials and overviews of trials
    • Peto R, Collins R, Gray R. Large-scale randomized evidence: Large, simple trials and overviews of trials. J Clin Epidemiol. 1995 ; 48: 23-40
    • (1995) J Clin Epidemiol , vol.48 , pp. 23-40
    • Peto, R.1    Collins, R.2    Gray, R.3
  • 13
    • 0021745696 scopus 로고
    • Why do we need some large, simple randomized trials?
    • Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials?. Stat Med. 1984 ; 3: 409-22
    • (1984) Stat Med , vol.3 , pp. 409-422
    • Yusuf, S.1    Collins, R.2    Peto, R.3
  • 16
    • 0035719934 scopus 로고    scopus 로고
    • Principles of effectiveness trials and their implementation in VA cooperative study #430: 'Reducing the efficacy-effectiveness gap in bipolar disorder'
    • Bauer MS, Williford WO, Dawson EE, et al. Principles of effectiveness trials and their implementation in VA Cooperative Study #430: 'Reducing the efficacy-effectiveness gap in bipolar disorder'. J Affect Disord. 2001 ; 67: 61-78
    • (2001) J Affect Disord , vol.67 , pp. 61-78
    • Bauer, M.S.1    Williford, W.O.2    Dawson, E.E.3
  • 18
    • 0014115513 scopus 로고
    • Explanatory and pragmatic attitudes in therapeutical trials
    • Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967 ; 20: 637-48
    • (1967) J Chronic Dis , vol.20 , pp. 637-648
    • Schwartz, D.1    Lellouch, J.2
  • 19
    • 57349108691 scopus 로고    scopus 로고
    • Improving the reporting of pragmatic trials: An extension of the CONSORT statement
    • Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving the reporting of pragmatic trials: An extension of the CONSORT statement. BMJ. 2008 ; 337: a2390
    • (2008) BMJ , vol.337 , pp. 2390
    • Zwarenstein, M.1    Treweek, S.2    Gagnier, J.J.3
  • 20
    • 63449090101 scopus 로고    scopus 로고
    • A pragmatic-explanatory continuum indicator summary (PRECIS): A tool to help trial designers
    • Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): A tool to help trial designers. J Clin Epidemiol. 2009 ; 62: 464-75
    • (2009) J Clin Epidemiol , vol.62 , pp. 464-475
    • Thorpe, K.E.1    Zwarenstein, M.2    Oxman, A.D.3
  • 21
    • 84859863807 scopus 로고    scopus 로고
    • Methodical standards and patient-centeredness in comparative effectiveness research: The PCORI perspective
    • Methodical standards and patient-centeredness in comparative effectiveness research: The PCORI perspective. JAMA. 2012 ; 307 (15). 1636-40
    • (2012) JAMA , vol.307 , Issue.15 , pp. 1636-1640
  • 22
    • 0033517302 scopus 로고    scopus 로고
    • The effect of spironolactone on morbidity and mortality in patients with severe health failure
    • Pitt B, Zannad F, Remme WJ, et al. The effect of spironolactone on morbidity and mortality in patients with severe health failure. N Engl J Med. 1999 ; 341: 709-17
    • (1999) N Engl J Med , vol.341 , pp. 709-717
    • Pitt, B.1    Zannad, F.2    Remme, W.J.3
  • 23
    • 3442886513 scopus 로고    scopus 로고
    • Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study
    • Juurlink DN, Mamdani MM, Lee DS, et al. Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study. N Engl J Med. 2004 ; 351: 543-51
    • (2004) N Engl J Med , vol.351 , pp. 543-551
    • Juurlink, D.N.1    Mamdani, M.M.2    Lee, D.S.3
  • 24
    • 0034707105 scopus 로고    scopus 로고
    • Comparison of upper gastrointestinal toxicity of rofecoxib and naproxenin patients with rheumatoid arthritis
    • Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxenin patients with rheumatoid arthritis. N Engl J Med. 2000 ; 343: 1520-28
    • (2000) N Engl J Med , vol.343 , pp. 1520-1528
    • Bombardier, C.1    Laine, L.2    Reicin, A.3
  • 25
    • 19744380776 scopus 로고    scopus 로고
    • Cardiovascular events associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial
    • Bresalier RS, Sandler RS, Quan H, et al. Cardiovascular events associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial. N Engl J Med. 2005 ; 352: 1092-102
    • (2005) N Engl J Med , vol.352 , pp. 1092-1102
    • Bresalier, R.S.1    Sandler, R.S.2    Quan, H.3
  • 26
    • 0037151906 scopus 로고    scopus 로고
    • Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs
    • Mamdani M, Rochon PA, Juurlink DN, et al. Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs. BMJ. 2002 ; 325: 624
    • (2002) BMJ , vol.325 , pp. 624
    • Mamdani, M.1    Rochon, P.A.2    Juurlink, D.N.3
  • 27
    • 33845682970 scopus 로고    scopus 로고
    • Changes in rates of upper gastrointestinal hemorrhage after the introduction of cyclooxygenase-2 inhibitors in British Columbia and Ontario
    • Mamdani M, Warren L, Kopp A, et al. Changes in rates of upper gastrointestinal hemorrhage after the introduction of cyclooxygenase-2 inhibitors in British Columbia and Ontario. CMAJ. 2006 ; 175 (12). 1535-38
    • (2006) CMAJ , vol.175 , Issue.12 , pp. 1535-1538
    • Mamdani, M.1    Warren, L.2    Kopp, A.3
  • 29
    • 29144453326 scopus 로고    scopus 로고
    • Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes
    • Nathan DM, Cleary PA, Backlund JY, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 ; 353: 2643-53
    • (2005) N Engl J Med , vol.353 , pp. 2643-2653
    • Nathan, D.M.1    Cleary, P.A.2    Backlund, J.Y.3
  • 30
    • 39549100109 scopus 로고    scopus 로고
    • Aprotinin during coronary-artery bypass grafting and risk of death
    • Schneeweiss S, Seeger JD, Landon J, Walker AM. Aprotinin during coronary-artery bypass grafting and risk of death. NEJM. 2008 ; 358: 771-83
    • (2008) NEJM , vol.358 , pp. 771-783
    • Schneeweiss, S.1    Seeger, J.D.2    Landon, J.3    Walker, A.M.4
  • 31
    • 33750965282 scopus 로고    scopus 로고
    • Simultaneous assessment of short-term gastrointestinal benefits and cardiovascular risks of selective COX-2 inhibitors and non-selective NSAIDs: An instrumental variable analysis
    • Schneeweiss S, Solomon DH, Wang PS, Brookhart MA. Simultaneous assessment of short-term gastrointestinal benefits and cardiovascular risks of selective COX-2 inhibitors and non-selective NSAIDs: An instrumental variable analysis. Arthritis Rheum. 2006 ; 54: 3390-98
    • (2006) Arthritis Rheum , vol.54 , pp. 3390-3398
    • Schneeweiss, S.1    Solomon, D.H.2    Wang, P.S.3    Brookhart, M.A.4
  • 33
    • 68249130994 scopus 로고    scopus 로고
    • Rethinking randomized clinical trials for comparative effectiveness research: The need for transformational change
    • Luce BR, Kramer JM, Goodman SN, et al. Rethinking randomized clinical trials for comparative effectiveness research: The need for transformational change. Ann Intern Med. 2009 ; 151 (3). 206-09
    • (2009) Ann Intern Med , vol.151 , Issue.3 , pp. 206-209
    • Luce, B.R.1    Kramer, J.M.2    Goodman, S.N.3
  • 35
    • 84928100580 scopus 로고    scopus 로고
    • Centers for Medicare and Medicaid Services (accessed 25 November 2009)
    • Centers for Medicare and Medicaid Services. NCD for computed tomography (220.1). 2008. Available at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd-id=220. 1&;ncd-version=2&basket=ncd%3A220%2E1%3A2%3AComputed+Tomography (accessed 25 November 2009).
    • (2008) NCD for Computed Tomography (220.1)
  • 36
    • 84855714220 scopus 로고    scopus 로고
    • Can coverage be rescinded when negative trial results threaten a popular procedure? the ongoing saga of vertebroplasty
    • Wulff KP, Miller FG, Pearson SD. Can coverage be rescinded when negative trial results threaten a popular procedure? The ongoing saga of vertebroplasty. Health Aff. 2011 ; 30 (12). 2269-76
    • (2011) Health Aff , vol.30 , Issue.12 , pp. 2269-2276
    • Wulff, K.P.1    Miller, F.G.2    Pearson, S.D.3
  • 37
    • 35748979414 scopus 로고    scopus 로고
    • Making a decision to wait for more evidence: When the National Institute for Health and Clinical Excellence recommends a technology only in the context of research
    • Chalkidou K, Andrew Hoy , Littlejohns P. Making a decision to wait for more evidence: When the National Institute for Health and Clinical Excellence recommends a technology only in the context of research. J R Soc Med. 2007 ; 100: 453-60
    • (2007) J R Soc Med , vol.100 , pp. 453-460
    • Chalkidou, K.1    Hoy, A.2    Littlejohns, P.3
  • 38
    • 77956513759 scopus 로고    scopus 로고
    • Using comparative effectiveness research to inform policy and practice in the British NHS: Past, present, and future
    • Chalkidou K, Walley T. Using comparative effectiveness research to inform policy and practice in the British NHS: Past, present, and future. Pharmacoeconomics. 2010 ; 28 (10). 1-13
    • (2010) Pharmacoeconomics , vol.28 , Issue.10 , pp. 1-13
    • Chalkidou, K.1    Walley, T.2
  • 39
    • 35348852468 scopus 로고    scopus 로고
    • Coverage with evidence development: A very good beginning, but much to be done. Commentary to Hutton et al
    • Tunis SR, Chalkidou K. Coverage with evidence development: A very good beginning, but much to be done. Commentary to Hutton et al. Int J Technol Assess Health Care. 2007 ; 23: 432-35
    • (2007) Int J Technol Assess Health Care , vol.23 , pp. 432-435
    • Tunis, S.R.1    Chalkidou, K.2
  • 41
    • 0010280366 scopus 로고    scopus 로고
    • The Association of the British Pharmaceutical Industry March (accessed 7 December 2009)
    • The Association of the British Pharmaceutical Industry. The pharmaceutical price and regulation scheme 2009, March2008. Available at: http://www.dh.gov.uk/prod-consum-dh/groups/dh-digitalassets/documents/ digitalasset/dh-098498.pdf (accessed 7 December 2009).
    • (2008) The Pharmaceutical Price and Regulation Scheme 2009
  • 42
    • 69949138043 scopus 로고    scopus 로고
    • Comparative effectiveness research in Ontario, Canada: Producing relevant and timely information for health care decision makers
    • Whicher DM, Chalkidou K, Dhalla IA, Levin L, Tunis S. Comparative effectiveness research in Ontario, Canada: Producing relevant and timely information for health care decision makers. Milbank Q. 2009 ; 87: 585-606
    • (2009) Milbank Q , vol.87 , pp. 585-606
    • Whicher, D.M.1    Chalkidou, K.2    Dhalla, I.A.3    Levin, L.4    Tunis, S.5
  • 43
    • 34848880527 scopus 로고    scopus 로고
    • Designed delays versus rigorous pragmatic trials: Lower carat gold standards can produce relevant drug evaluations
    • Maclure M, Carleton B, Schneeweiss S. Designed delays versus rigorous pragmatic trials: Lower carat gold standards can produce relevant drug evaluations. Med Care. 2007 ; 45: S44 - S49
    • (2007) Med Care , vol.45
    • MacLure, M.1    Carleton, B.2    Schneeweiss, S.3
  • 44
    • 84872829356 scopus 로고    scopus 로고
    • Center for Medical Technology Policy January (accessed 7 December 2009)
    • Center for Medical Technology Policy. Issue brief: Coverage for evidence development: A conceptual framework, January2009. Available at: http://www.cmtpnet.org/wp-content/uploads/downloads/2012/03/CED-Issue-Brief.pdf (accessed 7 December 2009).
    • (2009) Issue Brief: Coverage for Evidence Development: A Conceptual Framework
  • 45
    • 84872829501 scopus 로고    scopus 로고
    • Department of Veterans Affairs October (accessed 16 April 2012)
    • Department of Veterans Affairs. VA Cooperative Studies Program (CSP), October2011. Available at: http://www.research.va.gov/programs/csp/ (accessed 16 April 2012).
    • (2011) VA Cooperative Studies Program (CSP)
  • 46
    • 84872829907 scopus 로고    scopus 로고
    • AHRQ Practice-Based Research Networks (PBRNs) AHRQ Publication No. 01-P020. Agency for Healthcare Research and Quality, Rockville, MD (accessed 25 November 2009)
    • AHRQ Practice-Based Research Networks (PBRNs). Fact sheet June 2001 (revised May 2006). AHRQ Publication No. 01-P020. Agency for Healthcare Research and Quality, Rockville, MD. Available at: http://www.ahrq.gov/research/pbrn/ pbrnfact.htm (accessed 25 November 2009).
    • Fact Sheet June 2001 (Revised May 2006)
  • 47
    • 0035884198 scopus 로고    scopus 로고
    • Paradigm shifts in clinical trials enabled by information technology
    • Marks RG, Conlon M, Ruberg SJ. Paradigm shifts in clinical trials enabled by information technology. Stat Med. 2001 ; 20: 2683-96
    • (2001) Stat Med , vol.20 , pp. 2683-2696
    • Marks, R.G.1    Conlon, M.2    Ruberg, S.J.3
  • 50
    • 77953649158 scopus 로고    scopus 로고
    • Cluster randomized trials in comparative effectiveness research: Randomizing hospitals to test methods for prevention of healthcare-associated infections
    • Platt R, Takvorian SU, Septimus E, et al. Cluster randomized trials in comparative effectiveness research: Randomizing hospitals to test methods for prevention of healthcare-associated infections. Med Care. 2010 ; 48: S52 - S57
    • (2010) Med Care , vol.48
    • Platt, R.1    Takvorian, S.U.2    Septimus, E.3
  • 51
    • 79251494694 scopus 로고    scopus 로고
    • A multifaceted intervention for quality improvement in a network of intensive care units
    • Scales DC, Dainty K, Hales B, et al. A multifaceted intervention for quality improvement in a network of intensive care units. JAMA. 2011 ;:
    • (2011) JAMA
    • Scales, D.C.1    Dainty, K.2    Hales, B.3
  • 52
    • 85024092590 scopus 로고    scopus 로고
    • Institute of Medicine June (accessed 15 July 2010)
    • Institute of Medicine. Initial national priorities for comparative effectiveness research: Report brief, June2009. Available at: http://www.iom.edu/~/media/Files/Report%20Files/2009/ ComparativeEffectivenessResearchPriorities/CER%20report%20brief%2008-13-09.ashx (accessed 15 July 2010).
    • (2009) Initial National Priorities for Comparative Effectiveness Research: Report Brief
  • 53
    • 0029918188 scopus 로고    scopus 로고
    • Rationale and design for the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT Research Group
    • Davis BR, Cutler JA, Gordon DJ, et al. Rationale and design for the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT Research Group. Am J Hypertens. 1996 ; 9: 342-60
    • (1996) Am J Hypertens , vol.9 , pp. 342-360
    • Davis, B.R.1    Cutler, J.A.2    Gordon, D.J.3
  • 54
    • 0027240597 scopus 로고
    • An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. The GUSTO investigators
    • An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. The GUSTO investigators. N Engl J Med. 1993 ; 329: 673-82
    • (1993) N Engl J Med , vol.329 , pp. 673-682
  • 55
    • 0023805341 scopus 로고
    • Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2
    • Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet. 1988 ; 2: 349-60
    • (1988) Lancet , vol.2 , pp. 349-360
  • 56
    • 0036606736 scopus 로고    scopus 로고
    • Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? the Magpie Trial: A randomized placebo-controlled trial
    • Altman D, Carroli G, Duley L, et al. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: A randomized placebo-controlled trial. Lancet. 2002 ; 359 (9321). 1877-90
    • (2002) Lancet , vol.359 , Issue.9321 , pp. 1877-1890
    • Altman, D.1    Carroli, G.2    Duley, L.3
  • 57
    • 0013401756 scopus 로고    scopus 로고
    • National Cancer Institute (accessed 25 November 2009)
    • National Cancer Institute. Surveillance epidemiology and end results. Available at: http://seer.cancer.gov/ (accessed 25 November 2009).
    • Surveillance Epidemiology and End Results
  • 58
    • 77949484418 scopus 로고    scopus 로고
    • InFACT: A global critical care research response to H1N1
    • InFACT: A global critical care research response to H1N1. Lancet. 2009 ;:
    • (2009) Lancet
  • 60
    • 0029848062 scopus 로고    scopus 로고
    • Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability
    • Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ. 1996 ; 313: 1390-93
    • (1996) BMJ , vol.313 , pp. 1390-1393
    • Savulescu, J.1    Chalmers, I.2    Blunt, J.3
  • 61
    • 78751700368 scopus 로고    scopus 로고
    • Academy of Medical Sciences January (accessed 27 May 2011)
    • Academy of Medical Sciences. A new pathway for the regulation and governance of health research, January2011. Available at: http://www.acmedsci. ac.uk/p118pressid77.html (accessed 27 May 2011).
    • (2011) A New Pathway for the Regulation and Governance of Health Research
  • 62
    • 84872828348 scopus 로고    scopus 로고
    • Expert panel calls for reform in human subject protection
    • (accessed 26 May 2011)
    • ZakaibGD. Expert panel calls for reform in human subject protection. Nature Blog2011. Available at: http://blogs.nature.com/news/2011/05/panel-calls- for-reform-in-huma.html (accessed 26 May 2011).
    • (2011) Nature Blog
    • Zakaib, G.D.1
  • 63
    • 84872828429 scopus 로고    scopus 로고
    • Clinical Trials Transformation Initiative (accessed 16 April 2012)
    • Clinical Trials Transformation Initiative. Use of IRBs for multicenter clinical trials: Background. Available at: http://www.ctti-clinicaltrials.org/ project-topics/study-start-up/use-of-central-irbs-for-multiple-center-clinical- trials/background (accessed 16 April 2012).
    • Use of IRBs for Multicenter Clinical Trials: Background
  • 64
    • 27744561298 scopus 로고    scopus 로고
    • Research ethics committees: Agents of research policy?
    • Hemminki E. Research ethics committees: Agents of research policy?. Health Res Policy Syst. 2005 ; 3: 6
    • (2005) Health Res Policy Syst , vol.3 , pp. 6
    • Hemminki, E.1
  • 65
    • 40949108412 scopus 로고    scopus 로고
    • Specific barriers to the conduct of randomized trials
    • Duley L, Antman K, Arena J, et al. Specific barriers to the conduct of randomized trials. Clin Trials. 2008 ; 5 (1). 40-48
    • (2008) Clin Trials , vol.5 , Issue.1 , pp. 40-48
    • Duley, L.1    Antman, K.2    Arena, J.3
  • 66
    • 40949124713 scopus 로고    scopus 로고
    • Sensible guidelines for the conduct of large randomized trials
    • Yusuf S, Bosch J, Devereaux PJ, et al. Sensible guidelines for the conduct of large randomized trials. Clin Trials. 2008 ; 5 (1). 38-39
    • (2008) Clin Trials , vol.5 , Issue.1 , pp. 38-39
    • Yusuf, S.1    Bosch, J.2    Devereaux, P.J.3
  • 68
    • 84859837773 scopus 로고    scopus 로고
    • Addressing low-risk comparative effectiveness research in proposed changes to US federal regulations governing research
    • Kass N, Faden R, Tunis S. Addressing Low-Risk Comparative Effectiveness Research in Proposed Changes to US Federal Regulations Governing Research. JAMA. 2012 ; 307 (15). 1589-1590
    • (2012) JAMA , vol.307 , Issue.15 , pp. 1589-1590
    • Kass, N.1    Faden, R.2    Tunis, S.3
  • 69
    • 63049093102 scopus 로고    scopus 로고
    • The clinically-integrated randomized trial: Proposed novel method for conducting large trials at low cost
    • Vickers AJ, Scardino PT. The clinically-integrated randomized trial: Proposed novel method for conducting large trials at low cost. Trial. 2009 ; 10: 14-21
    • (2009) Trial , vol.10 , pp. 14-21
    • Vickers, A.J.1    Scardino, P.T.2
  • 70
    • 84863539781 scopus 로고    scopus 로고
    • Implementation of the Department of Veterans Affairs' first point-of-care clinical trial
    • D'Avolio L, Ferguson R, Goryachev S, et al. Implementation of the Department of Veterans Affairs' first point-of-care clinical trial. J Am Med Inform Assoc. 2012 ;:
    • (2012) J Am Med Inform Assoc
    • D'Avolio, L.1    Ferguson, R.2    Goryachev, S.3
  • 71
    • 84870524790 scopus 로고    scopus 로고
    • Stakeholder participation in comparative effectiveness research: Defining a framework for effective engagement
    • Deverka PA, Lavallee DC, Desai PJ, et al. Stakeholder participation in comparative effectiveness research: Defining a framework for effective engagement. J Comp Eff Res. 2012 ; 1 (2). 181-94
    • (2012) J Comp Eff Res , vol.1 , Issue.2 , pp. 181-194
    • Deverka, P.A.1    Lavallee, D.C.2    Desai, P.J.3
  • 72
    • 84872828522 scopus 로고    scopus 로고
    • Effectiveness guidance document: Recommendations for incorporating patient-reported outcomes into the design of clinical trials in adult oncology
    • (accessed 16 April 2012)
    • BaschEAbernethyAMullinsCDSpencerM. Effectiveness guidance document: Recommendations for incorporating patient-reported outcomes into the design of clinical trials in adult oncology. Center for Medical Technology Policy, 2011. Available at: http://www.cmtpnet.org/wp-content/uploads/downloads/2012/02/PRO- EGD-for-Public-Comment.pdf (accessed 16 April 2012).
    • (2011) Center for Medical Technology Policy
    • Basch, E.1    Abernethy, A.2    Mullins, C.D.3    Spencer, M.4
  • 73
    • 80155212434 scopus 로고    scopus 로고
    • Interactions between health technology assessment, coverage, and regulatory processes: Emerging issues, goals, and opportunities
    • Henshall C, Mardhani-Bayne L, Fronsdal KB, Klemp M. Interactions between health technology assessment, coverage, and regulatory processes: Emerging issues, goals, and opportunities. Int J Technol Assess Health Care. 2011 ; 27 (3). 253-60
    • (2011) Int J Technol Assess Health Care , vol.27 , Issue.3 , pp. 253-260
    • Henshall, C.1    Mardhani-Bayne, L.2    Fronsdal, K.B.3    Klemp, M.4
  • 75
    • 84872830535 scopus 로고    scopus 로고
    • Department of Health and Human Services (accessed 16 April 2012)
    • Department of Health and Human Services. NIH health care systems research collaboratory-Coordinating center (U54). Available at: http://grants.nih.gov/ grants/guide/rfa-files/RFA-RM-11-021.html (accessed 16 April 2012).
    • NIH Health Care Systems Research Collaboratory-Coordinating Center (U54)


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