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Volumn 155, Issue 1, 2008, Pages 33-41

Monitoring the ACTIVE-W trial: Some issues in monitoring a noninferiority trial

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; IRBESARTAN; PLACEBO;

EID: 36849062291     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2007.09.011     Document Type: Article
Times cited : (11)

References (18)
  • 1
    • 33744945247 scopus 로고    scopus 로고
    • Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomized controlled trial
    • ACTIVE Writing Group on behalf of the ACTIVE Investigators
    • ACTIVE Writing Group on behalf of the ACTIVE Investigators, Connolly S., Pogue J., Hart R., et al. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomized controlled trial. Lancet 367 (2006) 1903-1912
    • (2006) Lancet , vol.367 , pp. 1903-1912
    • Connolly, S.1    Pogue, J.2    Hart, R.3
  • 2
    • 0002219036 scopus 로고    scopus 로고
    • Active-control trials-a linguistic problem
    • Wittes J. Active-control trials-a linguistic problem. Int Chin Stat Soc Bull (2001) 39-40
    • (2001) Int Chin Stat Soc Bull , pp. 39-40
    • Wittes, J.1
  • 3
    • 0037472837 scopus 로고    scopus 로고
    • Non-inferiority trials: design concepts and issues-the encounters of academic consultants in statistics
    • D'Agostino R.B., Massaro J.M., and Sullivan L.M. Non-inferiority trials: design concepts and issues-the encounters of academic consultants in statistics. Stat Med 22 (2003) 169-186
    • (2003) Stat Med , vol.22 , pp. 169-186
    • D'Agostino, R.B.1    Massaro, J.M.2    Sullivan, L.M.3
  • 4
    • 15244355307 scopus 로고    scopus 로고
    • Choice of delta: requirements and reality-results of a systematic review
    • Lange S., and Freitag G. Choice of delta: requirements and reality-results of a systematic review. Biometrical J 1 (2005) 12-27
    • (2005) Biometrical J , vol.1 , pp. 12-27
    • Lange, S.1    Freitag, G.2
  • 5
    • 33644792767 scopus 로고    scopus 로고
    • Reporting of noninferiority and equivalence randomized trials. An extension of the CONSORT Statement
    • for the CONSORT Group
    • Piaggio G., Elbourne D.R., Altman D.G., et al., for the CONSORT Group. Reporting of noninferiority and equivalence randomized trials. An extension of the CONSORT Statement. JAMA 295 (2006) 1152-1160
    • (2006) JAMA , vol.295 , pp. 1152-1160
    • Piaggio, G.1    Elbourne, D.R.2    Altman, D.G.3
  • 6
    • 28244432534 scopus 로고    scopus 로고
    • Trials and tribulations of non-inferiority. The ximelagatran experience
    • Kaul S., Diamond G.A., and Weintraub W.S. Trials and tribulations of non-inferiority. The ximelagatran experience. J Am Coll Cardiol 46 (2005) 1986-1995
    • (2005) J Am Coll Cardiol , vol.46 , pp. 1986-1995
    • Kaul, S.1    Diamond, G.A.2    Weintraub, W.S.3
  • 7
    • 33845508231 scopus 로고    scopus 로고
    • Making sense of noninferiority: a clinical and statistical perspective on its application to cardiovascular clinical trials
    • Kaul S., and Diamond G.A. Making sense of noninferiority: a clinical and statistical perspective on its application to cardiovascular clinical trials. Progr Cardiovasc Dis 49 (2007) 284-299
    • (2007) Progr Cardiovasc Dis , vol.49 , pp. 284-299
    • Kaul, S.1    Diamond, G.A.2
  • 8
    • 0026011647 scopus 로고
    • Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial
    • Echt D.S., Liebson P.R., Mitchell L.B., et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 324 (1991) 781-788
    • (1991) N Engl J Med , vol.324 , pp. 781-788
    • Echt, D.S.1    Liebson, P.R.2    Mitchell, L.B.3
  • 9
    • 36849049765 scopus 로고    scopus 로고
    • The data monitoring experience in the Cardiac Arrhythmia Suppression Trial: the need to be prepared early
    • DeMets D.L., Furberg C.D., and Friedman L.M. (Eds), Springer, New York (NY)
    • DeMets D.L., and Friedman L.M. The data monitoring experience in the Cardiac Arrhythmia Suppression Trial: the need to be prepared early. In: DeMets D.L., Furberg C.D., and Friedman L.M. (Eds). Data monitoring in clinical trials (2006), Springer, New York (NY) 198-208
    • (2006) Data monitoring in clinical trials , pp. 198-208
    • DeMets, D.L.1    Friedman, L.M.2
  • 10
    • 0037125379 scopus 로고    scopus 로고
    • Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial
    • Rossouw J.E., Anderson G.L., Prentice R.L., et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 288 (2002) 321-333
    • (2002) JAMA , vol.288 , pp. 321-333
    • Rossouw, J.E.1    Anderson, G.L.2    Prentice, R.L.3
  • 11
    • 84989074109 scopus 로고
    • Stochastically curtailed sampling in long-term clinical trials
    • Lan K.K., Simon R., and Halperin M. Stochastically curtailed sampling in long-term clinical trials. Commun Stat Theory Methods 13 (1984) 2339-2353
    • (1984) Commun Stat Theory Methods , vol.13 , pp. 2339-2353
    • Lan, K.K.1    Simon, R.2    Halperin, M.3
  • 12
    • 0023677293 scopus 로고
    • The B-value: a tool for monitoring data
    • Lan K.K., and Wittes J. The B-value: a tool for monitoring data. Biometrics 44 (1988) 579-585
    • (1988) Biometrics , vol.44 , pp. 579-585
    • Lan, K.K.1    Wittes, J.2
  • 13
    • 0021951614 scopus 로고
    • The futility index. An approach to the cost-effective termination of randomized clinical trials
    • Ware J.H., Muller J.E., and Braunwald E. The futility index. An approach to the cost-effective termination of randomized clinical trials. Am J Med 78 (1985) 635-643
    • (1985) Am J Med , vol.78 , pp. 635-643
    • Ware, J.H.1    Muller, J.E.2    Braunwald, E.3
  • 14
    • 25444474448 scopus 로고    scopus 로고
    • A review of methods for futility stopping based on conditional power
    • Lachin J.M. A review of methods for futility stopping based on conditional power. Statis Med 24 (2005) 2747-2764
    • (2005) Statis Med , vol.24 , pp. 2747-2764
    • Lachin, J.M.1
  • 15
    • 0037872688 scopus 로고    scopus 로고
    • Composite outcomes in randomized trials. Greater precision but with greater uncertainty?
    • Freemantle N., Calvert M., Wood J., et al. Composite outcomes in randomized trials. Greater precision but with greater uncertainty?. JAMA 289 (2003) 2554-2559
    • (2003) JAMA , vol.289 , pp. 2554-2559
    • Freemantle, N.1    Calvert, M.2    Wood, J.3
  • 16
    • 20144373791 scopus 로고    scopus 로고
    • Validity of composite end points in clinical trials
    • Montori V.M., Permanyer-Miralda, Ferreira-Gonzalez, et al. Validity of composite end points in clinical trials. BMJ 330 (2005) 594-596
    • (2005) BMJ , vol.330 , pp. 594-596
    • Montori, V.M.1    Permanyer-Miralda2    Ferreira-Gonzalez3
  • 17
    • 33751221316 scopus 로고    scopus 로고
    • Bivalirudin for patients with acute coronary syndromes
    • Stone G.W., McLaurin B.T., Cox D.A., et al. 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
  • 18
    • 36849062123 scopus 로고    scopus 로고
    • Current controversies in data monitoring for clinical trials
    • Pocock S.J. 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


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.