메뉴 건너뛰기




Volumn 3, Issue 6, 2006, Pages 522-529

Futility approaches to interim monitoring by data monitoring committees

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIALS DATA MONITORING COMMITTEES; DECISION MAKING; HUMANS; MEDICAL FUTILITY; PROBABILITY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RISK FACTORS;

EID: 49749131610     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774506073115     Document Type: Conference Paper
Times cited : (44)

References (32)
  • 2
    • 59449092529 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use (CHMP) Guidelines. Guidelines on Data Monitoring Committees, European Medicine Agency, July
    • Committee for Medicinal Products for Human Use (CHMP) Guidelines. Guidelines on Data Monitoring Committees, European Medicine Agency, July 2005.
    • (2005)
  • 3
    • 59449090974 scopus 로고    scopus 로고
    • NIH policy for data and safety monitoring
    • National Institutes of Health
    • National Institutes of Health. NIH policy for data and safety monitoring. NIH Guide (http://grants2.nih.gov/grants/guide/notice-files/ not98-084.html), 1998.
    • (1998) NIH Guide
  • 5
    • 0023874973 scopus 로고
    • Organization, review, and administration of cooperative studies
    • Greenberg Report
    • Greenberg Report. Organization, review, and administration of cooperative studies. Control Clin Trials 1988; 9: 137-148.
    • (1988) Control Clin Trials , vol.9 , pp. 137-148
  • 6
    • 0034648728 scopus 로고    scopus 로고
    • Protecting research subjects - What must be done
    • Shalala D. Protecting research subjects - what must be done. New Engl J Med 2000; 343: 808-810.
    • (2000) New Engl J Med , vol.343 , pp. 808-810
    • Shalala, D.1
  • 7
    • 14944368720 scopus 로고    scopus 로고
    • COX-2 inhibitors - Lessons in drug safety
    • Psaty BM, Furberg CD. COX-2 inhibitors - lessons in drug safety. New Engl J Med 2005; 325: 1133-1135.
    • (2005) New Engl J Med , vol.325 , pp. 1133-1135
    • Psaty, B.M.1    Furberg, C.D.2
  • 9
    • 0020988490 scopus 로고
    • Experimental design features of the Coronary Drug Project
    • Canner PL, Klimt CR. Experimental design features of the Coronary Drug Project. Control Clin Trials 1983; 4: 313-332.
    • (1983) Control Clin Trials , vol.4 , pp. 313-332
    • Canner, P.L.1    Klimt, C.R.2
  • 10
    • 0027934302 scopus 로고
    • Interim analysis: The alpha spending function approach
    • DeMets DL, Lan KKG. Interim analysis: The alpha spending function approach. Stat in Med 1994; 13: 1341-1352.
    • (1994) Stat in Med , vol.13 , pp. 1341-1352
    • DeMets, D.L.1    Lan, K.K.G.2
  • 11
    • 84972500231 scopus 로고
    • Statistical approaches to interim monitoring of medical trials: A review and commentary
    • Jennison C, Turnbull BW. Statistical approaches to interim monitoring of medical trials: A review and commentary. Statistical Science 1990; 5: 299-317.
    • (1990) Statistical Science , vol.5 , pp. 299-317
    • Jennison, C.1    Turnbull, B.W.2
  • 12
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35: 549-556.
    • (1979) Biometrics , vol.35 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 13
    • 0033524162 scopus 로고    scopus 로고
    • The agonizing negative trend in monitoring clinical trials
    • DeMets DL, Pocock S, Julian DG. The agonizing negative trend in monitoring clinical trials. Lancet 1999; 354: 1983-1988.
    • (1999) Lancet , vol.354 , pp. 1983-1988
    • DeMets, D.L.1    Pocock, S.2    Julian, D.G.3
  • 14
    • 0023266532 scopus 로고
    • Effects of enalapril on mortality in severe congestive heart failure: Result 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: Result of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). New Engl J Med 1987; 316: 1429-1435.
    • (1987) New Engl J Med , vol.316 , pp. 1429-1435
  • 15
    • 0032006053 scopus 로고    scopus 로고
    • Effect of early captopril treatment on blood adrenaline levels in acute myocardial infarction (the substudy of ISIS-4). International Study of Infarct Survival-4
    • Budaj A, Herbaczynska-Cedro K, Kokot F et al. Effect of early captopril treatment on blood adrenaline levels in acute myocardial infarction (the substudy of ISIS-4). International Study of Infarct Survival-4. Amer J of Cardiol 1998; 81: 335-339.
    • (1998) Amer J of Cardiol , vol.81 , pp. 335-339
    • Budaj, A.1    Herbaczynska-Cedro, K.2    Kokot, F.3
  • 16
    • 0026072848 scopus 로고
    • Effect of oral milrinone on mortality in severe chronic heart failure
    • The PROMISE Study Research Group
    • Packer M, Carver JR, Rodeheffer RJ et al. Effect of oral milrinone on mortality in severe chronic heart failure. The PROMISE Study Research Group. N Engl J Med 1991; 325: 1468-1475.
    • (1991) N Engl J Med , vol.325 , pp. 1468-1475
    • Packer, M.1    Carver, J.R.2    Rodeheffer, R.J.3
  • 17
    • 0027322458 scopus 로고
    • Effects of vesnarinone on morbidity and mortality in patients with heart failure
    • for The Vesnarinone Study Group
    • Feldman AM, Bristow MR, Parmley WW et al. for The Vesnarinone Study Group. Effects of vesnarinone on morbidity and mortality in patients with heart failure. New Engl J Med 1993; 329: 149-155.
    • (1993) New Engl J Med , vol.329 , pp. 149-155
    • Feldman, A.M.1    Bristow, M.R.2    Parmley, W.W.3
  • 18
    • 0032542385 scopus 로고    scopus 로고
    • A dose-dependent increase in mortality with vesnarinone among patients with severe heart failure
    • for the Vesnarinone Trial Investigators
    • Cohn J, Goldstein S, Greenberg B et al. for the Vesnarinone Trial Investigators. A dose-dependent increase in mortality with vesnarinone among patients with severe heart failure. New Engl J Med 1998; 339: 1810-1816.
    • (1998) New Engl J Med , vol.339 , pp. 1810-1816
    • Cohn, J.1    Goldstein, S.2    Greenberg, B.3
  • 19
    • 0032146016 scopus 로고    scopus 로고
    • Heart and estrogen/progestin replacement study (HERS): Design, methods, and baseline characteri-stics
    • Grady D, Applegate W, Bush T et al. Heart and estrogen/progestin replacement study (HERS): Design, methods, and baseline characteri-stics. Control Clin Trials 1998; 19: 314-335.
    • (1998) Control Clin Trials , vol.19 , pp. 314-335
    • Grady, D.1    Applegate, W.2    Bush, T.3
  • 20
    • 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 Clinical Trial
    • Writing Group for the Women' s Health Initiative Investigators
    • Writing Group for the Women' s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Principal results from the Women' s Health Initiative Randomized Clinical Trial. JAMA 2002; 288: 321-333.
    • (2002) JAMA , vol.288 , pp. 321-333
  • 21
    • 1842867053 scopus 로고    scopus 로고
    • Effects of conjugated equine estrogen in postmenopausal women with hysterectomy. The Women' s Health Initiative Randomized Controlled Trial
    • The Women' s Health Initiative Steering Committee
    • The Women' s Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy. The Women' s Health Initiative Randomized Controlled Trial. JAMA 2004; 291: 1701-1712.
    • (2004) JAMA , vol.291 , pp. 1701-1712
  • 22
    • 1842831345 scopus 로고    scopus 로고
    • The WHI estrogen-alone trial-things look any better?
    • Editorial
    • Hulley SB, Grady D. The WHI estrogen-alone trial-things look any better? Editorial. JAMA 2004; 291: 1769-1771.
    • (2004) JAMA , vol.291 , pp. 1769-1771
    • Hulley, S.B.1    Grady, D.2
  • 23
    • 0016630250 scopus 로고
    • Clofibrate and niacin in coronary heart disease
    • Coronary Drug Project Research Group
    • Coronary Drug Project Research Group. Clofibrate and niacin in coronary heart disease. JAMA 1975; 231: 360-381.
    • (1975) JAMA , vol.231 , pp. 360-381
  • 24
    • 70449529019 scopus 로고
    • Discrete sequential boundaries for clinical trials
    • Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659-663.
    • (1983) Biometrika , vol.70 , pp. 659-663
    • Lan, K.K.G.1    DeMets, D.L.2
  • 25
    • 0024427644 scopus 로고
    • Symmetric group sequential test designs
    • Emerson SS, Fleming TR. Symmetric group sequential test designs. Biometrics 1989; 45: 905-932.
    • (1989) Biometrics , vol.45 , pp. 905-932
    • Emerson, S.S.1    Fleming, T.R.2
  • 26
    • 0021499106 scopus 로고
    • Exact confidence intervals following a group sequential test
    • Tsiatis AA, Rosner GL, Mehta CR. Exact confidence intervals following a group sequential test. Biometrics 1984; 40: 797-803.
    • (1984) Biometrics , vol.40 , pp. 797-803
    • Tsiatis, A.A.1    Rosner, G.L.2    Mehta, C.R.3
  • 27
    • 0020729398 scopus 로고
    • Group sequential clinical trials with triangular continuation regions
    • Whitehead J, Stratton I. Group sequential clinical trials with triangular continuation regions. Biometrics 1983; 39: 227-236.
    • (1983) Biometrics , vol.39 , pp. 227-236
    • Whitehead, J.1    Stratton, I.2
  • 28
    • 0033619169 scopus 로고    scopus 로고
    • A unified theory for sequential clinical trials
    • Whitehead J. A unified theory for sequential clinical trials. Stat Med 1999; 18: 2271-2286.
    • (1999) Stat Med , vol.18 , pp. 2271-2286
    • Whitehead, J.1
  • 29
    • 0023677293 scopus 로고
    • The B-value: A tool for monitoring data
    • Lan KKG, Wittes J. The B-value: A tool for monitoring data. Biometrics 1988; 44: 579-585.
    • (1988) Biometrics , vol.44 , pp. 579-585
    • Lan, K.K.G.1    Wittes, J.2
  • 30
    • 0027204760 scopus 로고
    • Sequential monitoring of clinical trials: The role of information in Brownian motion
    • Lan KKG, Zucker D. Sequential monitoring of clinical trials: The role of information in Brownian motion. Stat Med 1993; 12: 753-765.
    • (1993) Stat Med , vol.12 , pp. 753-765
    • Lan, K.K.G.1    Zucker, D.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.