메뉴 건너뛰기




Volumn 5, Issue 2, 2012, Pages 294-302

When to stop a clinical trial early for benefit: Lessons learned and future approaches

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CANDESARTAN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; EPLERENONE; PLACEBO; ROSUVASTATIN;

EID: 84860803495     PISSN: 19413289     EISSN: 19413297     Source Type: Journal    
DOI: 10.1161/CIRCHEARTFAILURE.111.965707     Document Type: Article
Times cited : (21)

References (45)
  • 2
    • 77954586754 scopus 로고    scopus 로고
    • Bias and trials stopped early for benefit
    • Korn EL, Freidlin B, Mooney M. Bias and trials stopped early for benefit. JAMA. 2010;304:157-158.
    • (2010) JAMA. , vol.304 , pp. 157-158
    • Korn, E.L.1    Freidlin, B.2    Mooney, M.3
  • 3
    • 77954580305 scopus 로고    scopus 로고
    • Bias and trials stopped early for benefit
    • Ellenberg SS, DeMets DL, Fleming TR. Bias and trials stopped early for benefit. JAMA. 2010;304:158-159.
    • (2010) JAMA. , vol.304 , pp. 158-159
    • Ellenberg, S.S.1    DeMets, D.L.2    Fleming, T.R.3
  • 4
    • 77954586754 scopus 로고    scopus 로고
    • Bias and trials stopped early for benefit
    • Goodman S, Berry D, Wittes J. Bias and trials stopped early for benefit. JAMA. 2010;304:157-159.
    • (2010) JAMA. , vol.304 , pp. 157-159
    • Goodman, S.1    Berry, D.2    Wittes, J.3
  • 5
    • 63749110127 scopus 로고    scopus 로고
    • Stopping or reporting early for positive results in randomized clinical trials: The National Cancer Institute Cooperative Group experience from 1990 to 2005
    • Korn EL, Freidlin B, Mooney M. Stopping or reporting early for positive results in randomized clinical trials: The National Cancer Institute Cooperative Group experience from 1990 to 2005. J Clin Oncol. 2009;27: 1712-1721.
    • (2009) J Clin Oncol. , vol.27 , pp. 1712-1721
    • Korn, E.L.1    Freidlin, B.2    Mooney, M.3
  • 6
    • 44949205473 scopus 로고    scopus 로고
    • Stopping a trial early in oncology: For patients or for industry?
    • DOI 10.1093/annonc/mdn042
    • Trotta F, Apolone G, Garattini S, Tafuri G. Stopping a trial early in oncology: For patients or for industry? Ann Oncol. 2008;19:1347-1353. (Pubitemid 351972203)
    • (2008) Annals of Oncology , vol.19 , Issue.7 , pp. 1347-1353
    • Trotta, F.1    Apolone, G.2    Garattini, S.3    Tafuri, G.4
  • 9
    • 19344371548 scopus 로고    scopus 로고
    • The data monitoring experience in the Candesartan in Heart Failure Assessment of Reduction in Mortality and morbidity (CHARM) program
    • DOI 10.1016/j.ahj.2004.10.038, PII S0002870305000189
    • Pocock S, Wang D, Wilhelmsen L, Hennekens CH. The data monitoring experience in the Candesartan in Heart Failure Assessment of Reduction in Mortality and morbidity (CHARM) program. Am Heart J. 2005;149: 939-943. (Pubitemid 40718898)
    • (2005) American Heart Journal , vol.149 , Issue.5 , pp. 939-943
    • Pocock, S.1    Wang, D.2    Wilhelmsen, L.3    Hennekens, C.H.4
  • 10
    • 27644556320 scopus 로고    scopus 로고
    • When (not) to stop a clinical trial for benefit
    • DOI 10.1001/jama.294.17.2228
    • Pocock SJ. When (not) to stop a clinical trial for benefit. JAMA. 2005; 294:2228-2230. (Pubitemid 41571143)
    • (2005) Journal of the American Medical Association , vol.294 , Issue.17 , pp. 2228-2230
    • Pocock, S.J.1
  • 11
    • 8444244421 scopus 로고    scopus 로고
    • The data monitoring experience in the MOXCON trial
    • DOI 10.1016/j.ehj.2004.09.015, PII S0195668X04006554
    • Pocock S, Wilhelmsen L, Dickstein K, Francis G, Wittes J. The data monitoring experience in the MOXCON trial. Eur Heart J. 2004;25: 1974-1978. (Pubitemid 39486015)
    • (2004) European Heart Journal , vol.25 , Issue.22 , pp. 1974-1978
    • Pocock, S.1    Wilhelmsen, L.2    Dickstein, K.3    Francis, G.4    Wittes, J.5
  • 12
    • 0037514264 scopus 로고    scopus 로고
    • Stopping medical research to save money: A broken pact with researchers and patients
    • DOI 10.1001/jama.289.16.2128
    • Psaty BM, Rennie D. Stopping medical research to save money: A broken pact with researchers and patients. JAMA. 2003;289:2128-2131. (Pubitemid 37430215)
    • (2003) Journal of the American Medical Association , vol.289 , Issue.16 , pp. 2128-2131
    • Psaty, B.M.1    Rennie, D.2
  • 13
    • 0033586193 scopus 로고    scopus 로고
    • Trials stopped early: Too good to be true?
    • DOI 10.1016/S0140-6736(98)00379-1
    • Pocock S, White I. Trials stopped early: Too good to be true? Lancet. 1999;353:943-944. (Pubitemid 29132599)
    • (1999) Lancet , vol.353 , Issue.9157 , pp. 943-944
    • Pocock, S.1    White, I.2
  • 17
    • 0034688194 scopus 로고    scopus 로고
    • Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients: The Heart Outcomes Prevention Evaluation Study Investigators
    • Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients: The Heart Outcomes Prevention Evaluation Study Investigators. N Engl J Med. 2000;342:145-153.
    • (2000) N Engl J Med , vol.342 , pp. 145-153
    • Yusuf, S.1    Sleight, P.2    Pogue, J.3    Bosch, J.4    Davies, R.5    Dagenais, G.6
  • 18
    • 24644443331 scopus 로고    scopus 로고
    • Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): A multicentre randomised controlled trial
    • DOI 10.1016/S0140-6736(05)67185-1, PII S0140673605671851
    • Dahlof B, Sever PS, Poulter NR, Wedel H, Beevers DG, Caulfield M, Collins R, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O'Brien E, Ostergren J. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): A multicentre randomised controlled trial. Lancet. 2005;366:895-906. (Pubitemid 41265663)
    • (2005) Lancet , vol.366 , Issue.9489 , pp. 895-906
    • Dahlof, B.1    Sever, P.S.2    Poulter, N.R.3    Wedel, H.4    Beevers, D.G.5    Caulfield, M.6    Collins, R.7    Kjeldsen, S.E.8    Kristinsson, A.9    McInnes, G.T.10    Mehlsen, J.11    Nieminen, M.12    O'Brien, E.13    Ostergren, J.14
  • 19
    • 0033514046 scopus 로고    scopus 로고
    • The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): A randomised trial
    • CIBIS II Investigators
    • CIBIS II Investigators. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): A randomised trial. Lancet. 1999;353:9-13.
    • (1999) Lancet. , vol.353 , pp. 9-13
  • 21
    • 77954190124 scopus 로고    scopus 로고
    • By Jove! What is a clinician to make of JUPITER?
    • Kaul S, Morrissey RP, Diamond GA. By Jove! What is a clinician to make of JUPITER? Arch Intern Med. 2010;170:1073-1077.
    • (2010) Arch Intern Med. , vol.170 , pp. 1073-1077
    • Kaul, S.1    Morrissey, R.P.2    Diamond, G.A.3
  • 22
    • 78049304338 scopus 로고    scopus 로고
    • The JUPITER Trial: Responding to the critics
    • Ridker PM, Glynn RJ. The JUPITER Trial: Responding to the critics. Am J Cardiol. 2010;106:1351-1356.
    • (2010) Am J Cardiol. , vol.106 , pp. 1351-1356
    • Ridker, P.M.1    Glynn, R.J.2
  • 23
    • 70450131191 scopus 로고    scopus 로고
    • The JUPITER trial: Results, controversies, and implications for prevention
    • Ridker PM. The JUPITER trial: Results, controversies, and implications for prevention. Circ Cardiovasc Qual Outcomes. 2009;2:279-285.
    • (2009) Circ Cardiovasc Qual Outcomes , vol.2 , pp. 279-285
    • Ridker, P.M.1
  • 25
    • 0030902115 scopus 로고    scopus 로고
    • Randomised trial of losartan versus captopril in patients over 65 with heart failure (Evaluation of Losartan in the Elderly Study, ELITE)
    • DOI 10.1016/S0140-6736(97)01187-2
    • Pitt B, Segal R, Martinez FA, Meurers G, Cowley AJ, Thomas I, Deedwania PC, Ney DE, Snavely DB, Chang PI. Randomised trial of losartan versus captopril in patients over 65 with heart failure (Evaluation of Losartan in the Elderly Study, ELITE). Lancet. 1997;349:747-752. (Pubitemid 27122456)
    • (1997) Lancet , vol.349 , Issue.9054 , pp. 747-752
    • Pitt, B.1    Segal, R.2    Martinez, F.A.3    Meurers, G.4    Cowley, A.J.5    Thomas, I.6    Deedwania, P.C.7    Ney, D.E.8    Snavely, D.B.9    Chang, P.I.10
  • 27
    • 0023266532 scopus 로고
    • Effects of enalapril on mortality in severe congestive heart failure: Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS)
    • CONSENSUS Trial Study Group
    • CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure: Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med. 1987; 316:1429-1435.
    • (1987) N Engl J Med. , vol.316 , pp. 1429-1435
  • 28
    • 0027998462 scopus 로고
    • Randomised trial of low-dose amiodarone in severe congestive heart failure: Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiaca en Argentina (GESICA)
    • Doval HC, Nul DR, Grancelli HO, Perrone SV, Bortman GR, Curiel R. Randomised trial of low-dose amiodarone in severe congestive heart failure: Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiaca en Argentina (GESICA). Lancet. 1994;344:493-498.
    • (1994) Lancet , vol.344 , pp. 493-498
    • Doval, H.C.1    Nul, D.R.2    Grancelli, H.O.3    Perrone, S.V.4    Bortman, G.R.5    Curiel, R.6
  • 29
    • 0029004921 scopus 로고
    • Amiodarone in patients with congestive heart failure and asymptomatic ventricular arrhythmia: Survival Trial of Antiarrhythmic Therapy in Congestive Heart Failure
    • Singh SN, Fletcher RD, Fisher SG, Singh BN, Lewis HD, Deedwania PC, Massie BM, Colling C, Lazzeri D. Amiodarone in patients with congestive heart failure and asymptomatic ventricular arrhythmia: Survival Trial of Antiarrhythmic Therapy in Congestive Heart Failure. N Engl J Med. 1995;333:77-82.
    • (1995) N Engl J Med , vol.333 , pp. 77-82
    • Singh, S.N.1    Fletcher, R.D.2    Fisher, S.G.3    Singh, B.N.4    Lewis, H.D.5    Deedwania, P.C.6    Massie, B.M.7    Colling, C.8    Lazzeri, D.9
  • 31
    • 0033549290 scopus 로고    scopus 로고
    • Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF)
    • MERIT-HF Investigators
    • MERIT-HF Investigators. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999;353:2001-2007.
    • (1999) Lancet. , vol.353 , pp. 2001-2007
  • 34
    • 0042410539 scopus 로고    scopus 로고
    • Effects of candesartan on mortality and morbidity in patients with chronic heart failure: The CHARM-overall programme
    • DOI 10.1016/S0140-6736(03)14282-1
    • Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJ, Michelson EL, Olofsson B, Ostergren J, Yusuf S, Pocock S. CHARM Investigators and Committees: Effects of candesartan on mortality and morbidity in patients with chronic heart failure: The CHARM-Overall programme. Lancet. 2003;362:759-766. (Pubitemid 37093915)
    • (2003) Lancet , vol.362 , Issue.9386 , pp. 759-766
    • Pfeffer, M.A.1    Swedberg, K.2    Granger, C.B.3    Held, P.4    McMurray, J.J.V.5    Michelson, E.L.6    Olofsson, B.7    Ostergren, J.8    Yusuf, S.9
  • 40
    • 36849062123 scopus 로고    scopus 로고
    • Current controversies in data monitoring for clinical trials
    • Pocock SJ. Current controversies in data monitoring for clinical trials. Clin Trials. 2006;3:513-521.
    • (2006) Clin Trials , vol.3 , pp. 513-521
    • Pocock, S.J.1
  • 41
    • 18744406319 scopus 로고    scopus 로고
    • Multiplicity in randomised trials II: Subgroup and interim analyses
    • DOI 10.1016/S0140-6736(05)66516-6, PII S0140673605665166
    • Schulz KF, Grimes DA. Multiplicity in randomised trials II: Subgroup and interim analyses. Lancet. 2005;365:1657-1661. (Pubitemid 40693416)
    • (2005) Lancet , vol.365 , Issue.9471 , pp. 1657-1661
    • Schulz, K.F.1    Grimes, D.A.2
  • 42
    • 17344371508 scopus 로고    scopus 로고
    • Data and safety monitoring
    • In: Armitage P, Colton T, eds Chichester, England: John Wiley & Sons
    • O'Brien P. Data and safety monitoring. In: Armitage P, Colton T, eds. Encyclopedia of Biostatistics. Chichester, England: John Wiley & Sons; 1998:1058-1066.
    • (1998) Encyclopedia of Biostatistics , pp. 1058-1066
    • O'Brien, P.1
  • 43
    • 41949085462 scopus 로고    scopus 로고
    • When should data and safety monitoring committees share interim results in cardiovascular trials?
    • DOI 10.1001/jama.299.14.1710
    • Borer JS, Gordon DJ, Geller NL. When should data and safety monitoring committees share interim results in cardiovascular trials? JAMA. 2008; 299:1710-1712. (Pubitemid 351519868)
    • (2008) JAMA - Journal of the American Medical Association , vol.299 , Issue.14 , pp. 1710-1712
    • Borer, J.S.1    Gordon, D.J.2    Geller, N.L.3
  • 44
    • 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
    • Fox K, Ford I, Steg PG, Tendera M, Ferrari R. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): A randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:807-816.
    • (2008) Lancet , vol.372 , pp. 807-816
    • Fox, K.1    Ford, I.2    Steg, P.G.3    Tendera, M.4    Ferrari, R.5
  • 45
    • 13844318810 scopus 로고    scopus 로고
    • A proposed charter for clinical trial data monitoring committees: Helping them to do their job well
    • DAMOCLES Study Group
    • DAMOCLES Study Group. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet. 2005;365:711-722.
    • (2005) Lancet , vol.365 , pp. 711-722


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.