메뉴 건너뛰기




Volumn 15, Issue 4, 2018, Pages 321-328

Data Monitoring Committees: Current issues

Author keywords

confidentiality; indemnification; Independence; mediator; mission

Indexed keywords

AMFEBUTAMONE; NALTREXONE;

EID: 85045144585     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774518764855     Document Type: Conference Paper
Times cited : (27)

References (20)
  • 1
    • 85017110535 scopus 로고    scopus 로고
    • Data Monitoring Committees: promoting best practices to address emerging challenges
    • Fleming TR, DeMets DL, Roe M. Data Monitoring Committees: promoting best practices to address emerging challenges. Clin Trials 2017; 14: 115–123
    • (2017) Clin Trials , vol.14 , pp. 115-123
    • Fleming, T.R.1    DeMets, D.L.2    Roe, M.3
  • 5
    • 33745128497 scopus 로고    scopus 로고
    • accessed 21 February 2018
    • European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on Data Monitoring Committees, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003635.pdf (accessed 21 February 2018)
    • Guideline on Data Monitoring Committees
  • 6
    • 85050497235 scopus 로고    scopus 로고
    • 16, June, 2016, (, accessed,) (in Japanese
    • Pharmaceuticals Medical Devices Agency. Guidance on Data Monitoring Committees (PFSB/ELD notification No. 0404-1), https://www.pmda.go.jp/files/000204620.pdf (2013, accessed 16 June 2016) (in Japanese)
    • (2013)
  • 7
    • 43649105816 scopus 로고    scopus 로고
    • Maintaining confidentiality of interim data to enhance trial integrity and credibility
    • Fleming TR, Sharples K, McCall J. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clin Trials 2008; 5: 157–167
    • (2008) Clin Trials , vol.5 , pp. 157-167
    • Fleming, T.R.1    Sharples, K.2    McCall, J.3
  • 8
    • 83455162665 scopus 로고    scopus 로고
    • What information should a sponsor of a randomized trial receive during its conduct?
    • Anand SS, Wittes J, Yusuf S., What information should a sponsor of a randomized trial receive during its conduct? Clin Trials 2011; 8: 716–719
    • (2011) Clin Trials , vol.8 , pp. 716-719
    • Anand, S.S.1    Wittes, J.2    Yusuf, S.3
  • 9
    • 0023413293 scopus 로고
    • Policies for study monitoring and interim reporting of results
    • Green SJ, Fleming TR, O’Fallon JR. Policies for study monitoring and interim reporting of results. J Clin Oncol 1987; 5: 1477–1484
    • (1987) J Clin Oncol , vol.5 , pp. 1477-1484
    • Green, S.J.1    Fleming, T.R.2    O’Fallon, J.R.3
  • 10
    • 20244368495 scopus 로고    scopus 로고
    • Issues in data monitoring and interim analysis of trials
    • iii–iv
    • Grant AM, Altman DG, Babiker AB.; Damocles Study Group. Issues in data monitoring and interim analysis of trials. Health Technol Assess 2005; 9: 1–238, iii–iv
    • (2005) Health Technol Assess , vol.9 , pp. 1-238
    • Grant, A.M.1    Altman, D.G.2    Babiker, A.B.3
  • 11
    • 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
  • 12
    • 84960918373 scopus 로고    scopus 로고
    • Effect of naltrexone-bupropion on major adverse cardiovascular events in overweight and obese patients with cardiovascular risk factors: a randomized clinical trial
    • Nissen SE, Wolski KE, Prcela L. Effect of naltrexone-bupropion on major adverse cardiovascular events in overweight and obese patients with cardiovascular risk factors: a randomized clinical trial. JAMA 2016; 315: 990–1004
    • (2016) JAMA , vol.315 , pp. 990-1004
    • Nissen, S.E.1    Wolski, K.E.2    Prcela, L.3
  • 13
    • 84960925181 scopus 로고    scopus 로고
    • Evaluation of the cardiovascular risk of naltrexone-bupropion: a study interrupted
    • Sharfstein JM, Psaty BM., Evaluation of the cardiovascular risk of naltrexone-bupropion: a study interrupted. JAMA 2016; 315: 984–986
    • (2016) JAMA , vol.315 , pp. 984-986
    • Sharfstein, J.M.1    Psaty, B.M.2
  • 14
    • 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: 1381–1382
    • (1998) N Engl J Med , vol.338 , pp. 1381-1382
    • Meinert, C.L.1
  • 15
    • 0026011647 scopus 로고
    • Mortality and morbidity in patients receiving encainide, flecainide, or placebo—The Cardiac Arrhythmia Suppression Trial
    • Echt DS, Liebson PR, Mitchell LB. Mortality and morbidity in patients receiving encainide, flecainide, or placebo—The Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991; 324: 781–788
    • (1991) N Engl J Med , vol.324 , pp. 781-788
    • Echt, D.S.1    Liebson, P.R.2    Mitchell, L.B.3
  • 16
    • 84918772240 scopus 로고    scopus 로고
    • Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents
    • Mauri L, Kereiakes DJ, Yeh RW. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med 2014; 371: 2155–2166
    • (2014) N Engl J Med , vol.371 , pp. 2155-2166
    • Mauri, L.1    Kereiakes, D.J.2    Yeh, R.W.3
  • 17
    • 84905986814 scopus 로고    scopus 로고
    • Enhancing trial integrity by protecting the independence of Data Monitoring Committees in clinical trials
    • Fleming TR, Hennekens CH, Pfeffer MA. Enhancing trial integrity by protecting the independence of Data Monitoring Committees in clinical trials. J Biopharm Stat 2014; 24: 968–975
    • (2014) J Biopharm Stat , vol.24 , pp. 968-975
    • Fleming, T.R.1    Hennekens, C.H.2    Pfeffer, M.A.3
  • 18
    • 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
  • 19
    • 33644618943 scopus 로고    scopus 로고
    • Liability issues for Data Monitoring Committee members
    • DeMets DL, Fleming TR, Rockhold F. Liability issues for Data Monitoring Committee members. Clin Trials 2004; 1: 525–531
    • (2004) Clin Trials , vol.1 , pp. 525-531
    • DeMets, D.L.1    Fleming, T.R.2    Rockhold, F.3
  • 20
    • 84990043625 scopus 로고    scopus 로고
    • Data Monitoring Committees—expect the unexpected
    • DeMets DL, Ellenberg SE., Data Monitoring Committees—expect the unexpected. N Engl J Med 2016; 375: 1365–1371
    • (2016) N Engl J Med , vol.375 , pp. 1365-1371
    • DeMets, D.L.1    Ellenberg, S.E.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.