메뉴 건너뛰기




Volumn 58, Issue 5, 2011, Pages 433-435

Should sponsors and dsmbs share interim results across trials?

Author keywords

[No Author keywords available]

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; NEVIRAPINE; ZIDOVUDINE;

EID: 81755174329     PISSN: 15254135     EISSN: 10779450     Source Type: Journal    
DOI: 10.1097/QAI.0b013e318236eca3     Document Type: Review
Times cited : (6)

References (23)
  • 2
    • 46849085220 scopus 로고    scopus 로고
    • Ethical and legal constraints on data sharing between countries in multinational epidemiological studies in Europe report from a joint workshop of the European League Against Rheumatism standing committee on epidemiology with the "AutoCure" project
    • DOI 10.1136/ard.2007.080598
    • Zink A, Silman AJ. Ethical and legal constraints on data sharing between countries in multinational epidemiological studies in Europe report from a joint workshop of the European league against rheumatism standing committee on epidemiology with the "Auto Cure" project. Ann Rheum Dis. 2008;67:1041-1043. (Pubitemid 351956672)
    • (2008) Annals of the Rheumatic Diseases , vol.67 , Issue.7 , pp. 1041-1043
    • Zink, A.1    Silman, A.J.2
  • 3
    • 0037307422 scopus 로고    scopus 로고
    • DSMB case study: Decision making when a similar clinical trial is stopped early
    • DOI 10.1016/S0197-2456(02)00274-X, PII S019724560200274X
    • Hillman DW, Louis TA. DSMB case study: decision making when a similar clinical trial is stopped early. Control Clin Trials. 2003;24:85-91. (Pubitemid 36135950)
    • (2003) Controlled Clinical Trials , vol.24 , Issue.1 , pp. 85-91
    • Hillman, D.W.1    Louis, T.A.2
  • 4
    • 0035091717 scopus 로고    scopus 로고
    • Regulatory issues for Data and Safety Monitoring Committees
    • DOI 10.1067/mhj.2001.113839
    • Fisher L, Klibaner M. Regulatory issues for data and safety monitoring committees. Am Heart J. 2001;141:536-541. (Pubitemid 32260717)
    • (2001) American Heart Journal , vol.141 , Issue.4 , pp. 536-541
    • Fisher, L.1    Klibaner, M.2
  • 5
    • 67650217955 scopus 로고    scopus 로고
    • Global health research, is it legitimate to stop clinical trials early on account of their opportunity costs?
    • Lavery JV, Singer PA, Ridzon R, et al. In global health research, is it legitimate to stop clinical trials early on account of their opportunity costs? PLoS Med. 2009;6:4-7.
    • (2009) PLoS Med , vol.6 , pp. 4-7
    • Lavery, J.V.1    Singer, P.A.2    Ridzon, R.3
  • 6
    • 77955083891 scopus 로고    scopus 로고
    • World Health Organization Accessed November 20, 2009
    • World Health Organization. Acceptable medical reasons for the use of breast-milk substitutes. 2009. Available at: http://whqlibdoc.who.int/hq/2009/ WHO-FCH-CAH-09.01-eng.pdf. Accessed November 20, 2009.
    • (2009) Acceptable Medical Reasons for the Use of Breast-milk Substitutes
  • 7
    • 27544469059 scopus 로고    scopus 로고
    • Medical research litigation and malpractice tort doctrines: Courts on a learning curve. 4 Hous
    • Morreim EH. Medical research litigation and malpractice tort doctrines: courts on a learning curve. 4 Hous. J. Health L. & Pol'y. 2004;4:1-86.
    • (2004) J. Health L. & Pol'y , vol.4 , pp. 1-86
    • Morreim, E.H.1
  • 8
    • 43649105816 scopus 로고    scopus 로고
    • Maintaining confidentiality of interim data to enhance trial integrity and credibility
    • DOI 10.1177/1740774508089459
    • Fleming TR, Sharples K, McCall J, et al. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clin Trials. 2008;5: 157-167. (Pubitemid 351682525)
    • (2008) Clinical Trials , vol.5 , Issue.2 , pp. 157-167
    • Fleming, T.R.1    Sharpies, K.2    McCall, J.3    Moore, A.4    Rodgers, A.5    Stewart, R.6
  • 9
    • 0003770817 scopus 로고    scopus 로고
    • Accessed June 10
    • NIH Policy for Data and Safety Monitoring Available at: http://grants. nih.gov/grants/guide/notice-files/not98-084.html. Accessed June 10
    • NIH Policy for Data and Safety Monitoring
  • 12
    • 0037108141 scopus 로고    scopus 로고
    • Monitoring clinical trials: Issues and controversies regarding confidentiality
    • Fleming TR, Ellenberg S, DeMets DL. Monitoring clinical trials: Issues and controversies regarding confidentiality. Stat Med. 2002;21:2843-2851.
    • (2002) Stat Med , vol.21 , pp. 2843-2851
    • Fleming, T.R.1    Ellenberg, S.2    Demets, D.L.3
  • 13
    • 0032919460 scopus 로고    scopus 로고
    • Data and safety monitoring in the Delta trial
    • DOI 10.1016/S0197-2456(99)00003-3, PII S0197245699000033
    • Armitage P. Delta data and safety monitoring committee, data and safety monitoring in the delta trial. Control Clin Trials. 1999;20:229-241. (Pubitemid 29219503)
    • (1999) Controlled Clinical Trials , vol.20 , Issue.3 , pp. 229-241
    • Armitage, P.1
  • 14
    • 0027382848 scopus 로고
    • A randomized trial of Vitamin A and Vitamin e supplementation for retinitis pigmentosa
    • Marmor MF. A randomized trial of Vitamin A and Vitamin E supplementation for retinitis pigmentosa. Arch Opthalmol. 1993;111: 1460-1461.
    • (1993) Arch Opthalmol , vol.111 , pp. 1460-1461
    • Marmor, M.F.1
  • 15
    • 0027382848 scopus 로고
    • A randomized trial of Vitamin A and Vitamin e supplementation for retinitis pigmentosa
    • Norton EW. A randomized trial of Vitamin A and Vitamin E supplementation for retinitis pigmentosa. Arch Opthalmol. 1993;111:1460.
    • (1993) Arch Opthalmol , vol.111 , pp. 1460
    • Norton, E.W.1
  • 16
    • 4544333778 scopus 로고    scopus 로고
    • Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials
    • DAMOCLES Group
    • Sydes MR, Spiegelhalter DJ, Altman DG, et al. DAMOCLES Group. Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials. Clin Trials. 2004;1:60-79.
    • (2004) Clin Trials , vol.1 , pp. 60-79
    • Sydes, M.R.1    Spiegelhalter, D.J.2    Altman, D.G.3
  • 17
    • 0024832356 scopus 로고
    • Practical problems in interim analyses, with particular regard to estimation
    • Pocock SJ, Hughes MD. Practical problems in interim analyses, with particular regard to estimation. Control Clin Trials. 1989;10(4 suppl): 209S-221S. (Pubitemid 20029387)
    • (1989) Controlled Clinical Trials , vol.10 , Issue.4 SUPPL.
    • Pocock, S.J.1    Hughes, M.D.2
  • 18
    • 84923652222 scopus 로고    scopus 로고
    • editorial and publishing policies Accessed May 12, 2010
    • PLoS Medicine, editorial and publishing policies. Available at: http://www.plosmedicine.org/static/policies.action#copyright. Accessed May 12, 2010.
    • PLoS Medicine
  • 19
    • 84908619137 scopus 로고    scopus 로고
    • Information for Authors Accessed June 9, 2011
    • The Lancet, Information for Authors. Available at: http://download. thelancet. com/flatcontentassets/authors/lancet-information-for-authors.pdf. Accessed June 9, 2011.
    • The Lancet
  • 20
  • 21
    • 0033993316 scopus 로고    scopus 로고
    • Ethical issues arising when interim data in clinical trials is restricted to independent data monitoring committees
    • Wells RJ, Gartside PS, McHenry CL. Ethical issues arising when interim data in clinical trials is restricted to independent data monitoring committees. IRB. 2000;22:7-11.
    • (2000) IRB , vol.22 , pp. 7-11
    • Wells, R.J.1    Gartside, P.S.2    McHenry, C.L.3
  • 22
    • 40649084135 scopus 로고    scopus 로고
    • Is it ethical to keep interim findings of randomized controlled trials confidential?
    • Miller FG, Wendler D. Is it ethical to keep interim findings of randomized controlled trials confidential? J Med Ethics. 2008;34:198-201.
    • (2008) J Med Ethics , vol.34 , pp. 198-201
    • Miller, F.G.1    Wendler, D.2
  • 23
    • 0033959017 scopus 로고    scopus 로고
    • Should data and safety monitoring boards share confidential interim data?
    • DOI 10.1016/S0197-2456(99)00042-2, PII S0197245699000422
    • Dixon DO, Lagakos SW. Should data and safety monitoring boards share confidential interim data? Control Clin Trials. 2000;21:1-6. (Pubitemid 30047054)
    • (2000) Controlled Clinical Trials , vol.21 , Issue.1 , pp. 1-6
    • Dixon, D.O.1    Lagakos, S.W.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.