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Volumn 66, Issue 25, 2015, Pages 2886-2898

Challenging Issues in Clinical Trial Design Part 4 of a 4-Part Series on Statistics for Clinical Trials

Author keywords

adaptive designs; Data Monitoring Committees; factorial designs; noninferiority trials; randomized controlled trials as topic; statistical stopping guidelines; strategy trials

Indexed keywords

ACETYLSALICYLIC ACID; APIXABAN; CANGRELOR; CAPTOPRIL; CLOPIDOGREL; DRONEDARONE; ENALAPRIL; FIBRINOGEN RECEPTOR ANTAGONIST; HEPARIN; HIRULOG; IVABRADINE; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PLACEBO; SACUBITRIL PLUS VALSARTAN; TORCETRAPIB;

EID: 84955454921     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2015.10.051     Document Type: Review
Times cited : (51)

References (63)
  • 1
    • 77954882772 scopus 로고    scopus 로고
    • Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) Accessed November 2, 2015
    • Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for industry: non-inferiority clinical trials. Draft guidance. 2010. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm202140.pdf. Accessed November 2, 2015.
    • (2010) Guidance for Industry: Non-inferiority Clinical Trials. Draft Guidance
  • 2
    • 84871484789 scopus 로고    scopus 로고
    • Reporting of noninferiority and equivalence randomized trials: Extension of the CONSORT 2010 statement
    • G. Piaggio, D.R. Elbourne, S.J. Pocock, et al. for the CONSORT Group Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement JAMA 308 2012 2594 2604
    • (2012) JAMA , vol.308 , pp. 2594-2604
    • Piaggio, G.1    Elbourne, D.R.2    Pocock, S.J.3
  • 3
    • 84871529395 scopus 로고    scopus 로고
    • How to use a noninferiority trial: Users' guides to the medical literature
    • S.M. Mulla, I.A. Scott, C.A. Jackevicius, and et al. How to use a noninferiority trial: users' guides to the medical literature JAMA 308 2012 2605 2611
    • (2012) JAMA , vol.308 , pp. 2605-2611
    • Mulla, S.M.1    Scott, I.A.2    Jackevicius, C.A.3
  • 4
    • 0030814329 scopus 로고    scopus 로고
    • Equivalence trials
    • J.H. Ware, and E.M. Antman Equivalence trials N Engl J Med 337 1997 1159 1161
    • (1997) N Engl J Med , vol.337 , pp. 1159-1161
    • Ware, J.H.1    Antman, E.M.2
  • 5
    • 33751221316 scopus 로고    scopus 로고
    • Bivalirudin for patients with acute coronary syndromes
    • G.W. Stone, B.T. McLaurin, D.A. Cox, et al. for the ACUITY Investigators Bivalirudin for patients with acute coronary syndromes N Engl J Med 355 2006 2203 2216
    • (2006) N Engl J Med , vol.355 , pp. 2203-2216
    • Stone, G.W.1    McLaurin, B.T.2    Cox, D.A.3
  • 6
    • 0034729993 scopus 로고    scopus 로고
    • Morbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT)
    • M.J. Brown, C.R. Palmer, A. Castaigne, and et al. Morbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT) Lancet 356 2000 366 372
    • (2000) Lancet , vol.356 , pp. 366-372
    • Brown, M.J.1    Palmer, C.R.2    Castaigne, A.3
  • 7
    • 84890373385 scopus 로고    scopus 로고
    • Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: The OPTIMIZE randomized trial
    • F. Feres, R.A. Costa, A. Abizaid, et al. for the OPTIMIZE Trial Investigators Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial JAMA 310 2013 2510 2522
    • (2013) JAMA , vol.310 , pp. 2510-2522
    • Feres, F.1    Costa, R.A.2    Abizaid, A.3
  • 8
    • 0037851836 scopus 로고    scopus 로고
    • Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) trial
    • H.R. Black, W.J. Elliott, G. Grandits, et al. for the CONVINCE Research Group Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) trial JAMA 289 2003 2073 2082
    • (2003) JAMA , vol.289 , pp. 2073-2082
    • Black, H.R.1    Elliott, W.J.2    Grandits, G.3
  • 9
    • 0043075814 scopus 로고    scopus 로고
    • Randomized comparison of distal protection with a filter-based catheter and a balloon occlusion and aspiration system during percutaneous intervention of diseased saphenous vein aorto-coronary bypass grafts
    • G.W. Stone, C. Rogers, J. Hermiller, et al. for the FilterWire EX Randomized Evaluation (FIRE) Investigators Randomized comparison of distal protection with a filter-based catheter and a balloon occlusion and aspiration system during percutaneous intervention of diseased saphenous vein aorto-coronary bypass grafts Circulation 108 2003 548 553
    • (2003) Circulation , vol.108 , pp. 548-553
    • Stone, G.W.1    Rogers, C.2    Hermiller, J.3
  • 12
    • 84944800184 scopus 로고    scopus 로고
    • Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes
    • B. Zinman, C. Wanner, J.M. Lachin, and et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes N Engl J Med 373 2015 2117 2128
    • (2015) N Engl J Med , vol.373 , pp. 2117-2128
    • Zinman, B.1    Wanner, C.2    Lachin, J.M.3
  • 13
    • 3042728223 scopus 로고    scopus 로고
    • Design, analysis and presentation of factorial randomised controlled trials
    • A.A. Montgomery, T.J. Peters, and P. Little Design, analysis and presentation of factorial randomised controlled trials BMC Med Res Methodol 3 2003 26
    • (2003) BMC Med Res Methodol , vol.3 , pp. 26
    • Montgomery, A.A.1    Peters, T.J.2    Little, P.3
  • 14
    • 0028342427 scopus 로고
    • Factorial trials in cardiology: Pros and cons
    • J. Lubsen, and S. Pocock Factorial trials in cardiology: pros and cons Eur Heart J 15 1994 585 588
    • (1994) Eur Heart J , vol.15 , pp. 585-588
    • Lubsen, J.1    Pocock, S.2
  • 15
    • 0034688194 scopus 로고    scopus 로고
    • Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients
    • Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients N Engl J Med 342 2000 145 153
    • (2000) N Engl J Med , vol.342 , pp. 145-153
  • 16
    • 0034688195 scopus 로고    scopus 로고
    • Heart Outcomes Prevention Evaluation Study Investigators. Vitamin E supplementation and cardiovascular events in high-risk patients
    • Heart Outcomes Prevention Evaluation Study Investigators. Vitamin E supplementation and cardiovascular events in high-risk patients N Engl J Med 342 2000 154 160
    • (2000) N Engl J Med , vol.342 , pp. 154-160
  • 17
    • 77956290748 scopus 로고    scopus 로고
    • Dose comparisons of clopidogrel and aspirin in acute coronary syndromes
    • CURRENT-OASIS 7 Investigators Dose comparisons of clopidogrel and aspirin in acute coronary syndromes N Engl J Med 363 2010 930 942
    • (2010) N Engl J Med , vol.363 , pp. 930-942
  • 18
    • 44249122195 scopus 로고    scopus 로고
    • Bivalirudin during primary PCI in acute myocardial infarction
    • G.W. Stone, B. Witzenbichler, G. Guagliumi, et al. for the HORIZONS-AMI Trial Investigators Bivalirudin during primary PCI in acute myocardial infarction N Engl J Med 358 2008 2218 2230
    • (2008) N Engl J Med , vol.358 , pp. 2218-2230
    • Stone, G.W.1    Witzenbichler, B.2    Guagliumi, G.3
  • 19
    • 65649091641 scopus 로고    scopus 로고
    • Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction
    • G.W. Stone, A.J. Lansky, S.J. Pocock, et al. for the HORIZONS-AMI Trial Investigators Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction N Engl J Med 360 2009 1946 1959
    • (2009) N Engl J Med , vol.360 , pp. 1946-1959
    • Stone, G.W.1    Lansky, A.J.2    Pocock, S.J.3
  • 20
    • 0028932732 scopus 로고
    • ISIS-4: A randomised factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58,050 patients with suspected acute myocardial infarction
    • ISIS-4 (Fourth International Study of Infarct Survival) Collaborative Group ISIS-4: a randomised factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58,050 patients with suspected acute myocardial infarction Lancet 345 1995 669 685
    • (1995) Lancet , vol.345 , pp. 669-685
  • 21
    • 84941286905 scopus 로고    scopus 로고
    • Bivalirudin or unfractionated heparin in acute coronary syndromes
    • M. Valgimigli, E. Frigoli, S. Leonardi, et al. for the MATRIX Investigators Bivalirudin or unfractionated heparin in acute coronary syndromes N Engl J Med 373 2015 997 1009
    • (2015) N Engl J Med , vol.373 , pp. 997-1009
    • Valgimigli, M.1    Frigoli, E.2    Leonardi, S.3
  • 22
    • 84931577241 scopus 로고    scopus 로고
    • Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: A randomised multicentre trial
    • M. Valgimigli, A. Gagnor, P. Calabró, et al. for the MATRIX Investigators Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial Lancet 385 2015 2465 2476
    • (2015) Lancet , vol.385 , pp. 2465-2476
    • Valgimigli, M.1    Gagnor, A.2    Calabró, P.3
  • 23
    • 0141684982 scopus 로고    scopus 로고
    • Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy
    • S.R. Tunis, D.B. Stryer, and C.M. Clancy Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy JAMA 290 2003 1624 1632
    • (2003) JAMA , vol.290 , pp. 1624-1632
    • Tunis, S.R.1    Stryer, D.B.2    Clancy, C.M.3
  • 24
    • 84908134911 scopus 로고    scopus 로고
    • Do current clinical trials meet society's needs? A critical review of recent evidence
    • S.J. Pocock, and B.J. Gersh Do current clinical trials meet society's needs? A critical review of recent evidence J Am Coll Cardiol 64 2014 1615 1628
    • (2014) J Am Coll Cardiol , vol.64 , pp. 1615-1628
    • Pocock, S.J.1    Gersh, B.J.2
  • 26
    • 84952919122 scopus 로고    scopus 로고
    • Medical therapy with versus without routine revascularization in patients with stable ischemic heart disease and moderate or severe ischemia: The case for community equipoise
    • G.W. Stone, J.S. Hochman, D.O. Williams, and et al. Medical therapy with versus without routine revascularization in patients with stable ischemic heart disease and moderate or severe ischemia: the case for community equipoise J Am Coll Cardiol 67 2016 81 99
    • (2016) J Am Coll Cardiol , vol.67 , pp. 81-99
    • Stone, G.W.1    Hochman, J.S.2    Williams, D.O.3
  • 27
    • 82555192609 scopus 로고    scopus 로고
    • Is cardiac catheterization necessary before initial management of patients with stable ischemic heart disease? Results from a Web-based survey of cardiologists
    • D.J. Maron, G.W. Stone, D.S. Berman, and et al. Is cardiac catheterization necessary before initial management of patients with stable ischemic heart disease? Results from a Web-based survey of cardiologists Am Heart J 162 2011 1034 1043.e13
    • (2011) Am Heart J , vol.162 , pp. 1034-1043e13
    • Maron, D.J.1    Stone, G.W.2    Berman, D.S.3
  • 28
    • 79958204372 scopus 로고    scopus 로고
    • Transcatheter versus surgical aortic-valve replacement in high-risk patients
    • C.R. Smith, M.B. Leon, M.J. Mack, et al. for the PARTNER Trial Investigators Transcatheter versus surgical aortic-valve replacement in high-risk patients N Engl J Med 364 2011 2187 2198
    • (2011) N Engl J Med , vol.364 , pp. 2187-2198
    • Smith, C.R.1    Leon, M.B.2    Mack, M.J.3
  • 29
    • 84899811656 scopus 로고    scopus 로고
    • Transcatheter aortic-valve replacement with a self-expanding prosthesis
    • D.H. Adams, J.J. Popma, M.J. Reardon, et al. for the U.S. CoreValve Clinical Investigators Transcatheter aortic-valve replacement with a self-expanding prosthesis N Engl J Med 370 2014 1790 1798
    • (2014) N Engl J Med , vol.370 , pp. 1790-1798
    • Adams, D.H.1    Popma, J.J.2    Reardon, M.J.3
  • 30
    • 34247113737 scopus 로고    scopus 로고
    • Optimal medical therapy with or without PCI for stable coronary disease
    • W.E. Boden, R.A. O'Rourke, K.K. Teo, et al. for the COURAGE Trial Research Group Optimal medical therapy with or without PCI for stable coronary disease N Engl J Med 356 2007 1503 1516
    • (2007) N Engl J Med , vol.356 , pp. 1503-1516
    • Boden, W.E.1    O'Rourke, R.A.2    Teo, K.K.3
  • 31
    • 61849104535 scopus 로고    scopus 로고
    • Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease
    • [Erratum in N Engl J Med 2013;368:584]
    • P.W. Serruys, M.C. Morice, A.P. Kappetein, et al. for the SYNTAX Investigators Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease [Erratum in N Engl J Med 2013;368:584] N Engl J Med 360 2009 961 972
    • (2009) N Engl J Med , vol.360 , pp. 961-972
    • Serruys, P.W.1    Morice, M.C.2    Kappetein, A.P.3
  • 32
    • 84930691483 scopus 로고    scopus 로고
    • Long-term safety of drug-eluting and bare-metal stents: Evidence from a comprehensive network meta-analysis
    • T. Palmerini, U. Benedetto, G. Biondi-Zoccai, and et al. Long-term safety of drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis J Am Coll Cardiol 65 2015 2496 2507
    • (2015) J Am Coll Cardiol , vol.65 , pp. 2496-2507
    • Palmerini, T.1    Benedetto, U.2    Biondi-Zoccai, G.3
  • 33
    • 84903318337 scopus 로고    scopus 로고
    • Revascularisation versus medical treatment in patients with stable coronary artery disease: Network meta-analysis
    • S. Windecker, S. Stortecky, G.G. Stefanini, and et al. Revascularisation versus medical treatment in patients with stable coronary artery disease: network meta-analysis BMJ 348 2014 g3859
    • (2014) BMJ , vol.348 , pp. g3859
    • Windecker, S.1    Stortecky, S.2    Stefanini, G.G.3
  • 34
    • 0034702184 scopus 로고    scopus 로고
    • Randomized trials or observational tribulations?
    • S.J. Pocock, and D.R. Elbourne Randomized trials or observational tribulations? N Engl J Med 342 2000 1907 1909
    • (2000) N Engl J Med , vol.342 , pp. 1907-1909
    • Pocock, S.J.1    Elbourne, D.R.2
  • 35
    • 54849161700 scopus 로고    scopus 로고
    • From randomized trials to registry studies: Translating data into clinical information
    • M.L. Brown, B.J. Gersh, D.R. Holmes, and et al. From randomized trials to registry studies: translating data into clinical information Nat Clin Pract Cardiovasc Med 5 2008 613 620
    • (2008) Nat Clin Pract Cardiovasc Med , vol.5 , pp. 613-620
    • Brown, M.L.1    Gersh, B.J.2    Holmes, D.R.3
  • 36
    • 84907424166 scopus 로고    scopus 로고
    • Outcomes 1 year after thrombus aspiration for myocardial infarction
    • B. Lagerqvist, O. Fröbert, G.K. Olivecrona, and et al. Outcomes 1 year after thrombus aspiration for myocardial infarction N Engl J Med 371 2014 1111 1120
    • (2014) N Engl J Med , vol.371 , pp. 1111-1120
    • Lagerqvist, B.1    Fröbert, O.2    Olivecrona, G.K.3
  • 38
    • 84860803495 scopus 로고    scopus 로고
    • When to stop a clinical trial early for benefit: Lessons learned and future approaches
    • F. Zannad, W. Gattis Stough, J.J.V. McMurray, and et al. When to stop a clinical trial early for benefit: lessons learned and future approaches Circ Heart Fail 5 2012 294 302
    • (2012) Circ Heart Fail , vol.5 , pp. 294-302
    • Zannad, F.1    Gattis Stough, W.2    McMurray, J.J.V.3
  • 39
    • 13844318810 scopus 로고    scopus 로고
    • A proposed charter for clinical trial data monitoring committees: Helping them to do their job well
    • DAMOCLES Study Group A proposed charter for clinical trial data monitoring committees: helping them to do their job well Lancet 365 2005 711 722
    • (2005) Lancet , vol.365 , pp. 711-722
  • 40
    • 36849062123 scopus 로고    scopus 로고
    • Current controversies in data monitoring for clinical trials
    • S.J. Pocock Current controversies in data monitoring for clinical trials Clin Trials 3 2006 513 521
    • (2006) Clin Trials , vol.3 , pp. 513-521
    • Pocock, S.J.1
  • 41
    • 84907087561 scopus 로고    scopus 로고
    • Angiotensin-neprilysin inhibition versus enalapril in heart failure
    • J.J.V. McMurray, M. Packer, A.S. Desai, et al. for the PARADIGM-HF Investigators and Committees Angiotensin-neprilysin inhibition versus enalapril in heart failure N Engl J Med 371 2014 993 1004
    • (2014) N Engl J Med , vol.371 , pp. 993-1004
    • McMurray, J.J.V.1    Packer, M.2    Desai, A.S.3
  • 42
    • 77956612624 scopus 로고    scopus 로고
    • Ivabradine and outcomes in chronic heart failure (SHIFT): A randomised placebo-controlled study
    • K. Swedberg, M. Komajda, M. Böhm, et al. for the SHIFT Investigators Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study Lancet 376 2010 875 885
    • (2010) Lancet , vol.376 , pp. 875-885
    • Swedberg, K.1    Komajda, M.2    Böhm, M.3
  • 43
    • 50649109186 scopus 로고    scopus 로고
    • Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): A randomised, double-blind, placebo-controlled trial
    • K. Fox, I. Ford, P.G. Steg, et al. for the BEAUTIFUL Investigators Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial Lancet 372 2008 807 816
    • (2008) Lancet , vol.372 , pp. 807-816
    • Fox, K.1    Ford, I.2    Steg, P.G.3
  • 44
    • 27644487803 scopus 로고    scopus 로고
    • Randomized trials stopped early for benefit: A systematic review
    • V.M. Montori, P.J. Devereaux, N.J. Adhikari, and et al. Randomized trials stopped early for benefit: a systematic review JAMA 294 2005 2203 2209
    • (2005) JAMA , vol.294 , pp. 2203-2209
    • Montori, V.M.1    Devereaux, P.J.2    Adhikari, N.J.3
  • 45
    • 77149150913 scopus 로고    scopus 로고
    • Futility interim monitoring with control of type i and II error probabilities using the interim Z-value or confidence limit
    • J.M. Lachin Futility interim monitoring with control of type I and II error probabilities using the interim Z-value or confidence limit Clin Trials 6 2009 565 573
    • (2009) Clin Trials , vol.6 , pp. 565-573
    • Lachin, J.M.1
  • 46
    • 79958770159 scopus 로고    scopus 로고
    • Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): A randomised, double-blind, parallel-group trial
    • M.-G. Bousser, P. Amarenco, A. Chamorro, et al. for the PERFORM Study Investigators Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial Lancet 377 2011 2013 2022
    • (2011) Lancet , vol.377 , pp. 2013-2022
    • Bousser, M.-G.1    Amarenco, P.2    Chamorro, A.3
  • 47
    • 84875500204 scopus 로고    scopus 로고
    • Treatment of anemia with darbepoetin alfa in systolic heart failure
    • K. Swedberg, J.B. Young, I.S. Anand, et al. for the RED-HF Investigators Treatment of anemia with darbepoetin alfa in systolic heart failure N Engl J Med 368 2013 1210 1219
    • (2013) N Engl J Med , vol.368 , pp. 1210-1219
    • Swedberg, K.1    Young, J.B.2    Anand, I.S.3
  • 48
    • 0033524162 scopus 로고    scopus 로고
    • The agonising negative trend in monitoring of clinical trials
    • D.L. DeMets, S.J. Pocock, and D.G. Julian The agonising negative trend in monitoring of clinical trials Lancet 354 1999 1983 1988
    • (1999) Lancet , vol.354 , pp. 1983-1988
    • DeMets, D.L.1    Pocock, S.J.2    Julian, D.G.3
  • 49
    • 36348975228 scopus 로고    scopus 로고
    • Effects of torcetrapib in patients at high risk for coronary events
    • P.J. Barter, M. Caulfield, M. Eriksson, et al. for the ILLUMINATE Investigators Effects of torcetrapib in patients at high risk for coronary events N Engl J Med 357 2007 2109 2122
    • (2007) N Engl J Med , vol.357 , pp. 2109-2122
    • Barter, P.J.1    Caulfield, M.2    Eriksson, M.3
  • 50
    • 84855163167 scopus 로고    scopus 로고
    • Dronedarone in high-risk permanent atrial fibrillation
    • S.J. Connolly, A.J. Camm, J.L. Halperin, et al. for the PALLAS Investigators Dronedarone in high-risk permanent atrial fibrillation N Engl J Med 365 2011 2268 2276
    • (2011) N Engl J Med , vol.365 , pp. 2268-2276
    • Connolly, S.J.1    Camm, A.J.2    Halperin, J.L.3
  • 51
    • 60549097431 scopus 로고    scopus 로고
    • Effect of dronedarone on cardiovascular events in atrial fibrillation
    • S.H. Hohnloser, H.J.G.M. Crijns, M. van Eickels, et al. for the ATHENA Investigators Effect of dronedarone on cardiovascular events in atrial fibrillation N Engl J Med 360 2009 668 678
    • (2009) N Engl J Med , vol.360 , pp. 668-678
    • Hohnloser, S.H.1    Crijns, H.J.G.M.2    Van Eickels, M.3
  • 52
    • 80052162121 scopus 로고    scopus 로고
    • Apixaban with antiplatelet therapy after acute coronary syndrome
    • J.H. Alexander, R.D. Lopes, S. James, et al. for the APPRAISE-2 Investigators Apixaban with antiplatelet therapy after acute coronary syndrome N Engl J Med 365 2011 699 708
    • (2011) N Engl J Med , vol.365 , pp. 699-708
    • Alexander, J.H.1    Lopes, R.D.2    James, S.3
  • 53
    • 33646245937 scopus 로고    scopus 로고
    • Adaptive designs in clinical drug development - An executive summary of the PhRMA Working Group
    • discussion 285-91
    • P. Gallo, C. Chuang-Stein, V. Dragalin, et al. for the PhRMA Working Group Adaptive designs in clinical drug development - an executive summary of the PhRMA Working Group J Biopharm Stat 16 2006 275 283 discussion 285-91
    • (2006) J Biopharm Stat , vol.16 , pp. 275-283
    • Gallo, P.1    Chuang-Stein, C.2    Dragalin, V.3
  • 54
    • 44949171503 scopus 로고    scopus 로고
    • Adaptive design methods in clinical trials - A review
    • S.C. Chow, and M. Chang Adaptive design methods in clinical trials - a review Orphanet J Rare Dis 3 2008 11
    • (2008) Orphanet J Rare Dis , vol.3 , pp. 11
    • Chow, S.C.1    Chang, M.2
  • 56
    • 77954875817 scopus 로고    scopus 로고
    • Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) Accessed November 2, 2015
    • Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for industry: adaptive design clinical trials for drugs and biologics. Draft guidance. 2010. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf. Accessed November 2, 2015.
    • (2010) Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics. Draft Guidance
  • 57
    • 82055200248 scopus 로고    scopus 로고
    • Adaptive increase in sample size when interim results are promising: A practical guide with examples
    • C.R. Mehta, and S.J. Pocock Adaptive increase in sample size when interim results are promising: a practical guide with examples Stat Med 30 2011 3267 3284
    • (2011) Stat Med , vol.30 , pp. 3267-3284
    • Mehta, C.R.1    Pocock, S.J.2
  • 58
    • 84904425514 scopus 로고    scopus 로고
    • Data-driven treatment selection for seamless phase II/III trials incorporating early-outcome data
    • C.U. Kunz, T. Friede, N. Parsons, and et al. Data-driven treatment selection for seamless phase II/III trials incorporating early-outcome data Pharm Stat 13 2014 238 246
    • (2014) Pharm Stat , vol.13 , pp. 238-246
    • Kunz, C.U.1    Friede, T.2    Parsons, N.3
  • 59
    • 84888318018 scopus 로고    scopus 로고
    • Adaptive enrichment designs for clinical trials
    • N. Simon, and R. Simon Adaptive enrichment designs for clinical trials Biostatistics 14 2013 613 625
    • (2013) Biostatistics , vol.14 , pp. 613-625
    • Simon, N.1    Simon, R.2
  • 60
    • 0032989951 scopus 로고    scopus 로고
    • Randomized play-the-winner clinical trials: Review and recommendations
    • W.F. Rosenberger Randomized play-the-winner clinical trials: review and recommendations Control Clin Trials 20 1999 328 342
    • (1999) Control Clin Trials , vol.20 , pp. 328-342
    • Rosenberger, W.F.1
  • 61
    • 71849087338 scopus 로고    scopus 로고
    • Platelet inhibition with cangrelor in patients undergoing PCI
    • R.A. Harrington, G.W. Stone, S. McNulty, and et al. Platelet inhibition with cangrelor in patients undergoing PCI N Engl J Med 361 2009 2318 2329
    • (2009) N Engl J Med , vol.361 , pp. 2318-2329
    • Harrington, R.A.1    Stone, G.W.2    McNulty, S.3
  • 62
    • 61349150491 scopus 로고    scopus 로고
    • Optimizing trial design: Sequential, adaptive, and enrichment strategies
    • C. Mehta, P. Gao, D.L. Bhatt, and et al. Optimizing trial design: sequential, adaptive, and enrichment strategies Circulation 119 2009 597 605
    • (2009) Circulation , vol.119 , pp. 597-605
    • Mehta, C.1    Gao, P.2    Bhatt, D.L.3
  • 63
    • 84875779761 scopus 로고    scopus 로고
    • Effect of platelet inhibition with cangrelor during PCI on ischemic events
    • D.L. Bhatt, G.W. Stone, K.W. Mahaffey, et al. for the CHAMPION PHOENIX Investigators Effect of platelet inhibition with cangrelor during PCI on ischemic events N Engl J Med 368 2013 1303 1313
    • (2013) N Engl J Med , vol.368 , pp. 1303-1313
    • Bhatt, D.L.1    Stone, G.W.2    Mahaffey, K.W.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.