Data safety and monitoring boards

被引:64
作者
Slutsky, AS
Lavery, JV
机构
[1] St Michaels Hosp, Dept Med, Toronto, ON M5B 1W8, Canada
[2] St Michaels Hosp, Dept Crit Care, Toronto, ON M5B 1W8, Canada
[3] St Michaels Hosp, Ctr Global Hlth Res, Toronto, ON M5B 1W8, Canada
[4] St Michaels Hosp, Inner City Hlth Res Unit, Toronto, ON M5B 1W8, Canada
[5] Univ Toronto, Dept Med, Toronto, ON, Canada
[6] Univ Toronto, Dept Surg, Toronto, ON, Canada
[7] Univ Toronto, Dept Biomed Engn, Toronto, ON, Canada
[8] Univ Toronto, Dept Publ Hlth Sci, Toronto, ON, Canada
[9] Univ Toronto, Joint Ctr Bioeth, Toronto, ON, Canada
关键词
D O I
10.1056/NEJMsb033476
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
[No abstract available]
引用
收藏
页码:1143 / 1147
页数:5
相关论文
共 21 条
  • [1] Efficacy and safety of tifacogin (recombinant tissue factor pathway inhibitor) in severe sepsis -: A randomized controlled trial
    Abraham, E
    Reinhart, K
    Opal, S
    Demeyer, I
    Doig, C
    Rodriguez, AL
    Beale, R
    Svoboda, P
    Laterre, PF
    Simon, S
    Light, B
    Spapen, H
    Stone, J
    Seibert, A
    Peckelsen, C
    De Deyne, C
    Postier, R
    Pettilä, V
    Sprung, CL
    Artigas, A
    Percell, SR
    Shu, V
    Zwingelstein, C
    Tobias, J
    Poole, L
    Stolzenbach, JC
    Creasey, AA
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2003, 290 (02): : 238 - 247
  • [3] [Anonymous], 2002, Data monitoring committees in clinical trials: A practical perspective
  • [4] EARLY STOPPING RULES - CLINICAL PERSPECTIVES AND ETHICAL CONSIDERATIONS
    BAUM, M
    HOUGHTON, J
    ABRAMS, K
    [J]. STATISTICS IN MEDICINE, 1994, 13 (13-14) : 1459 - 1469
  • [5] Statistical approaches and policies for the operations of Data and Safety Monitoring Committees
    Califf, RM
    Ellenberg, SS
    [J]. AMERICAN HEART JOURNAL, 2001, 141 (02) : 301 - 305
  • [6] INTERIM ANALYSIS - THE ALPHA-SPENDING FUNCTION-APPROACH
    DEMETS, DL
    LAN, KKG
    [J]. STATISTICS IN MEDICINE, 1994, 13 (13-14) : 1341 - 1352
  • [7] Should data and safety monitoring boards share confidential interim data?
    Dixon, DO
    Lagakos, SW
    [J]. CONTROLLED CLINICAL TRIALS, 2000, 21 (01): : 1 - 6
  • [8] *FDA, 2001, GUID CLIN TRIAL SPON
  • [9] Monitoring clinical trials: issues and controversies regarding confidentiality
    Fleming, TR
    Ellenberg, S
    DeMets, DL
    [J]. STATISTICS IN MEDICINE, 2002, 21 (19) : 2843 - 2851
  • [10] Gordon Valery M, 1998, IRB, V20, P1, DOI 10.2307/3564020