Data and safety monitoring in the Delta trial

被引:6
作者
Armitage, P [1 ]
机构
[1] Univ Oxford, St Peters Coll, Oxford, England
来源
CONTROLLED CLINICAL TRIALS | 1999年 / 20卷 / 03期
关键词
AIDS trials; HIV infection; data and safety monitoring; interim analyses; survival data;
D O I
10.1016/S0197-2456(99)00003-3
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Delta was a randomized trial designed to test whether combinations of zidovudine (AZT) with didanosine (ddI) or zalcitabine (ddC) were more effective than AZT alone for HIV-infected persons. A Data and Safety Monitoring Committee (DSMC) monitored accumulating data. This paper describes the deliberations and recommendations of the DSMC, as clear-cut differences in efficacy gradually emerged during the later stages of the trial. Control Clin Trials 1999;20:229-241 (C) Elsevier Science Inc., 1999.
引用
收藏
页码:229 / 241
页数:13
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