메뉴 건너뛰기




Volumn 375, Issue 14, 2016, Pages 1365-1371

Data monitoring committees - Expect the unexpected

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; EZETIMIBE; EZETIMIBE PLUS SIMVASTATIN; METOPROLOL; PLACEBO; PROPRANOLOL; ROFECOXIB; SIMVASTATIN;

EID: 84990043625     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMra1510066     Document Type: Review
Times cited : (48)

References (49)
  • 1
    • 0023874973 scopus 로고
    • Organization, review, and administration of cooperative studies (Greenberg Report): A report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967
    • Heart Special Project Committee. Organization, review, and administration of cooperative studies (Greenberg Report): a report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967. Control Clin Trials 1988; 9: 137-48.
    • (1988) Control Clin Trials , vol.9 , pp. 137-148
  • 4
    • 0032493079 scopus 로고    scopus 로고
    • Masked monitoring in clinical trials - Blind stupidity?
    • Meinert CL. Masked monitoring in clinical trials - blind stupidity? N Engl J Med 1998; 338: 1381-2.
    • (1998) N Engl J Med , vol.338 , pp. 1381-1382
    • Meinert, C.L.1
  • 5
    • 0016630250 scopus 로고
    • Clofibrate and niacin in coronary heart disease
    • Clofibrate and niacin in coronary heart disease. JAMA 1975; 231: 360-81.
    • (1975) JAMA , vol.231 , pp. 360-381
  • 6
    • 0019564664 scopus 로고
    • Practical aspects of decision making in clinical trials: The coronary drug project as a case study
    • The Coronary Drug Project Research Group. Practical aspects of decision making in clinical trials: the coronary drug project as a case study. Control Clin Trials 1981; 1: 363-76.
    • (1981) Control Clin Trials , vol.1 , pp. 363-376
  • 7
    • 0021025847 scopus 로고
    • The Coronary Drug Project: Monitoring of the data for evidence of adverse or beneficial treatment effects
    • Canner PL. The Coronary Drug Project: monitoring of the data for evidence of adverse or beneficial treatment effects. Control Clin Trials 1983; 4: 467-83.
    • (1983) Control Clin Trials , vol.4 , pp. 467-483
    • Canner, P.L.1
  • 8
    • 0027566177 scopus 로고
    • Practical issues in data monitoring of clinical trials: Proceedings of a workshop, Bethesda, Maryland, 27-28 January 1992
    • Practical issues in data monitoring of clinical trials: proceedings of a workshop, Bethesda, Maryland, 27-28 January 1992. Stat Med 1993; 12: 415-616.
    • (1993) Stat Med , vol.12 , pp. 415-616
  • 9
    • 0029591767 scopus 로고
    • The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials
    • DeMets DL, Fleming TR, Whitley RJ, et al. The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials. Control Clin Trials 1995; 16: 408-21.
    • (1995) Control Clin Trials , vol.16 , pp. 408-421
    • DeMets, D.L.1    Fleming, T.R.2    Whitley, R.J.3
  • 10
    • 84860444921 scopus 로고    scopus 로고
    • Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010
    • Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA 2012; 307: 1838-47.
    • (2012) JAMA , vol.307 , pp. 1838-1847
    • Califf, R.M.1    Zarin, D.A.2    Kramer, J.M.3    Sherman, R.E.4    Aberle, L.H.5    Tasneem, A.6
  • 11
    • 0035092538 scopus 로고    scopus 로고
    • The role of an independent statistical analysis center in the industry-modified National Institutes of Health model
    • Fisher M, Roecker EB, DeMets D. The role of an independent statistical analysis center in the industry-modified National Institutes of Health model. Drug Inf J 2001; 35: 115-29.
    • (2001) Drug Inf J , vol.35 , pp. 115-129
    • Fisher, M.1    Roecker, E.B.2    DeMets, D.3
  • 13
    • 0020078179 scopus 로고
    • A randomized trial of propranolol in patients with acute myocardial infarction. I. Mortality results
    • A randomized trial of propranolol in patients with acute myocardial infarction. I. Mortality results. JAMA 1982; 247: 1707-14.
    • (1982) JAMA , vol.247 , pp. 1707-1714
  • 14
    • 0021748109 scopus 로고
    • Statistical aspects of early termination in the Beta-Blocker Heart Attack Trial
    • DeMets DL, Hardy R, Friedman LM, Lan KKG. Statistical aspects of early termination in the Beta-Blocker Heart Attack Trial. Control Clin Trials 1984; 5: 362-72.
    • (1984) Control Clin Trials , vol.5 , pp. 362-372
    • DeMets, D.L.1    Hardy, R.2    Friedman, L.M.3    Lan, K.K.G.4
  • 15
    • 0025784574 scopus 로고
    • Issues in the early termination of the aspirin component of the Physicians' Health Study
    • Cairns J, Cohen L, Colton T, et al. Issues in the early termination of the aspirin component of the Physicians' Health Study. Ann Epidemiol 1991; 1: 395-405.
    • (1991) Ann Epidemiol , vol.1 , pp. 395-405
    • Cairns, J.1    Cohen, L.2    Colton, T.3
  • 16
    • 34548616370 scopus 로고    scopus 로고
    • Monitoring the randomized trials of the Women's Health Initiative: The experience of the data and safety monitoring board
    • Wittes J, Barrett-Connor E, Braunwald E, et al. Monitoring the randomized trials of the Women's Health Initiative: the experience of the data and safety monitoring board. Clin Trials 2007; 4: 218-34.
    • (2007) Clin Trials , vol.4 , pp. 218-234
    • Wittes, J.1    Barrett-Connor, E.2    Braunwald, E.3
  • 17
    • 0033524162 scopus 로고    scopus 로고
    • The agonising negative trend in monitoring of clinical trials
    • DeMets DL, Pocock SJ, Julian DG. The agonising negative trend in monitoring of clinical trials. Lancet 1999; 354: 1983-8.
    • (1999) Lancet , vol.354 , pp. 1983-1988
    • DeMets, D.L.1    Pocock, S.J.2    Julian, D.G.3
  • 18
    • 0024321898 scopus 로고
    • Preliminary report: Effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction
    • The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med 1989; 321: 406-12.
    • (1989) N Engl J Med , vol.321 , pp. 406-412
  • 19
    • 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)
    • Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet 1999; 353: 2001-7.
    • (1999) Lancet , vol.353 , pp. 2001-2007
  • 20
    • 0037108141 scopus 로고    scopus 로고
    • Monitoring clinical trials: Issues and controversies regarding confidentiality
    • Fleming TR, Ellenberg SS, DeMets DL. Monitoring clinical trials: issues and controversies regarding confidentiality. Stat Med 2002; 21: 2843-51.
    • (2002) Stat Med , vol.21 , pp. 2843-2851
    • Fleming, T.R.1    Ellenberg, S.S.2    DeMets, D.L.3
  • 21
    • 84922374669 scopus 로고    scopus 로고
    • Protecting the confidentiality of interim data: Addressing current challenges
    • Fleming TR. Protecting the confidentiality of interim data: addressing current challenges. Clin Trials 2015; 12: 5-11.
    • (2015) Clin Trials , vol.12 , pp. 5-11
    • Fleming, T.R.1
  • 22
    • 0033984619 scopus 로고    scopus 로고
    • Relationships between data monitoring committees
    • DeMets DL. Relationships between data monitoring committees. Control Clin Trials 2000; 21: 54-5.
    • (2000) Control Clin Trials , vol.21 , pp. 54-55
    • DeMets, D.L.1
  • 24
    • 0032919460 scopus 로고    scopus 로고
    • Data and safety monitoring in the Delta trial
    • Armitage P. Data and safety monitoring in the Delta trial. Control Clin Trials 1999; 20: 229-41.
    • (1999) Control Clin Trials , vol.20 , pp. 229-241
    • Armitage, P.1
  • 25
    • 84931411520 scopus 로고    scopus 로고
    • Ezetimibe added to statin therapy after acute coronary syndromes
    • Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med 2015; 372: 2387-97.
    • (2015) N Engl J Med , vol.372 , pp. 2387-2397
    • Cannon, C.P.1    Blazing, M.A.2    Giugliano, R.P.3
  • 26
    • 79959746706 scopus 로고    scopus 로고
    • The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): A randomised placebo-controlled trial
    • Baigent C, Landray MJ, Reith C, et al. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet 2011; 377: 2181-92.
    • (2011) Lancet , vol.377 , pp. 2181-2192
    • Baigent, C.1    Landray, M.J.2    Reith, C.3
  • 27
    • 52649120889 scopus 로고    scopus 로고
    • Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis
    • Rossebø AB, Pedersen TR, Boman K, et al. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med 2008; 359: 1343-56.
    • (2008) N Engl J Med , vol.359 , pp. 1343-1356
    • Rossebø, A.B.1    Pedersen, T.R.2    Boman, K.3
  • 28
    • 84990067804 scopus 로고    scopus 로고
    • House panel seeks Vytorin study data
    • August 1
    • Mundy A. House panel seeks Vytorin study data. Wall Street Journal. August 1, 2008 (http://www .wsj .com/ articles/ SB121754522285302457).
    • (2008) Wall Street Journal
    • Mundy, A.1
  • 29
    • 52649138998 scopus 로고    scopus 로고
    • Analyses of cancer data from three ezetimibe trials
    • Peto R, Emberson J, Landray M, et al. Analyses of cancer data from three ezetimibe trials. N Engl J Med 2008; 359: 1357-66.
    • (2008) N Engl J Med , vol.359 , pp. 1357-1366
    • Peto, R.1    Emberson, J.2    Landray, M.3
  • 31
    • 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
  • 32
    • 55749105531 scopus 로고    scopus 로고
    • Cardiovascular events associated with rofecoxib: Final analysis of the APPROVe trial
    • Baron JA, Sandler RS, Bresalier RS, et al. Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. Lancet 2008; 372: 1756-64.
    • (2008) Lancet , vol.372 , pp. 1756-1764
    • Baron, J.A.1    Sandler, R.S.2    Bresalier, R.S.3
  • 33
    • 58849158070 scopus 로고    scopus 로고
    • Merck agrees to settle Vioxx suits for $4.85 billion
    • November 9
    • Berenson A. Merck agrees to settle Vioxx suits for $4.85 billion. New York Times. November 9, 2007 (http://www .nytimes .com/ 2007/ 11/ 09/ business/ 09merck .html).
    • (2007) New York Times
    • Berenson, A.1
  • 34
    • 75749093972 scopus 로고    scopus 로고
    • Data safety monitoring boards: Legal and ethical considerations for research accountability
    • Tereskerz PM. Data safety monitoring boards: legal and ethical considerations for research accountability. Account Res 2010; 17: 30-50.
    • (2010) Account Res , vol.17 , pp. 30-50
    • Tereskerz, P.M.1
  • 35
    • 33644618943 scopus 로고    scopus 로고
    • Liability issues for data monitoring committee members
    • DeMets DL, Fleming TR, Rockhold F, et al. Liability issues for data monitoring committee members. Clin Trials 2004; 1: 525-31.
    • (2004) Clin Trials , vol.1 , pp. 525-531
    • DeMets, D.L.1    Fleming, T.R.2    Rockhold, F.3
  • 36
    • 0015131639 scopus 로고
    • Repeated assessment of results in clinical trials of cancer treatment
    • Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol 1971; 44: 793-7.
    • (1971) Br J Radiol , vol.44 , pp. 793-797
    • Haybittle, J.L.1
  • 37
    • 0017042882 scopus 로고
    • Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design
    • Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 1976; 34: 585-612.
    • (1976) Br J Cancer , vol.34 , pp. 585-612
    • Peto, R.1    Pike, M.C.2    Armitage, P.3
  • 38
    • 0017744944 scopus 로고
    • Group sequential methods in design and analysis of clinical trials
    • Pocock SJ. Group sequential methods in design and analysis of clinical trials. Biometrika 1977; 64: 191-200.
    • (1977) Biometrika , vol.64 , pp. 191-200
    • Pocock, S.J.1
  • 39
    • 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: 549-56.
    • (1979) Biometrics , vol.35 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 40
    • 0028086560 scopus 로고
    • Sequential methods based on the boundaries approach for the clinical comparison of survival times
    • discussion 1369-70
    • Whitehead J. Sequential methods based on the boundaries approach for the clinical comparison of survival times. Stat Med 1994; 13: 1357-68, discussion 1369-70.
    • (1994) Stat Med , vol.13 , pp. 1357-1368
    • Whitehead, J.1
  • 41
    • 70449529019 scopus 로고
    • Discrete sequential boundaries for clinical trials
    • Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659-63.
    • (1983) Biometrika , vol.70 , pp. 659-663
    • Lan, K.K.G.1    DeMets, D.L.2
  • 42
    • 56749097184 scopus 로고    scopus 로고
    • Early antiretroviral therapy and mortality among HIV-infected infants
    • Violari A, Cotton MF, Gibb DM, et al. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med 2008; 359: 2233-44.
    • (2008) N Engl J Med , vol.359 , pp. 2233-2244
    • Violari, A.1    Cotton, M.F.2    Gibb, D.M.3
  • 43
    • 17944379905 scopus 로고    scopus 로고
    • Challenges of subgroup analyses in multinational clinical trials: Experiences from the MERIT-HF trial
    • Wedel H, Demets D, Deedwania P, et al. Challenges of subgroup analyses in multinational clinical trials: experiences from the MERIT-HF trial. Am Heart J 2001; 142: 502-11.
    • (2001) Am Heart J , vol.142 , pp. 502-511
    • Wedel, H.1    Demets, D.2    Deedwania, P.3
  • 44
    • 84879520764 scopus 로고    scopus 로고
    • International differences in treatment effect: Do they really exist and why?
    • Pocock S, Calvo G, Marrugat J, et al. International differences in treatment effect: do they really exist and why? Eur Heart J 2013; 34: 1846-52.
    • (2013) Eur Heart J , vol.34 , pp. 1846-1852
    • Pocock, S.1    Calvo, G.2    Marrugat, J.3
  • 45
    • 34547167603 scopus 로고    scopus 로고
    • Expression of concern: Kiel et al. Efficacy of a hip protector to prevent hip fracture in nursing home residents: The HIP PRO randomized controlled trial
    • Bauchner H, Fontanarosa PB. Expression of concern: Kiel et al. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial - JAMA 2007;298(4):413-422.
    • (2007) JAMA , vol.298 , Issue.4 , pp. 413-422
    • Bauchner, H.1    Fontanarosa, P.B.2
  • 46
    • 84871326117 scopus 로고    scopus 로고
    • Expression of concern: Kiel et al. Efficacy of a hip protector to prevent hip fracture in nursing home residents: The HIP PRO randomized controlled trial
    • JAMA 2012; 308: 2519.
    • (2012) JAMA , vol.308 , pp. 2519
    • Bauchner, H.1    Fontanarosa, P.B.2
  • 47
    • 84990067839 scopus 로고    scopus 로고
    • Letter from Lisa Buchanan and Lisa A., Irvine Tasker, Bruce E. Jarrell, and Evan D. Kharasch, June 21,now archived at
    • Letter from Lisa Buchanan and Lisa A. Rooney, Office of the Secretary, Office of Public Health and Science, to Kathryn W. Irvine Tasker, Bruce E. Jarrell, and Evan D. Kharasch, June 21, 2011 (now archived at http://wayback .archive-it .org/ 4657/ 20150826185638/ http://www .hhs .gov/ ohrp/ compliance/ letters/ 2011 .html).
    • (2011) Rooney, Office of the Secretary, Office of Public Health and Science, to Kathryn W
  • 48
    • 34547167603 scopus 로고    scopus 로고
    • Efficacy of a hip protector to prevent hip fracture in nursing home residents: The HIP PRO randomized controlled trial
    • Kiel DP, Magaziner J, Zimmerman S, et al. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA 2007; 298: 413-22.
    • (2007) JAMA , vol.298 , pp. 413-422
    • Kiel, D.P.1    Magaziner, J.2    Zimmerman, S.3
  • 49
    • 84990040456 scopus 로고    scopus 로고
    • Silver Spring, MD, July 28-29
    • Clinical Trials Transformation Initiative (CTTI). CTTI Data Monitoring Committee Project expert meeting, Silver Spring, MD, July 28-29, 2015 (https:/ / www .ctti-clinicaltrials .org/ briefing-room/ meetings/ ctti-data-monitoring-committees -project-expert-meeting).
    • (2015) CTTI Data Monitoring Committee Project Expert Meeting


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.