Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial
Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial
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DOI：
10.1016/s0197-2456(02)00268-4
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发表时间：
2003-02-01
期刊：
影响因子：
--
通讯作者：
Meinert, CL
中科院分区：
文献类型：
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作者：
Gilpin, AMK;Holbrook, JT;Meinert, CL
我们报告了艾滋病单克隆抗体巨细胞病毒视网膜炎眼部并发症研究试验提前终止的两个特点：一是与治疗效果监测机构（政策和数据监测委员会[PDMB]）的审议过程有关，二是与PDMB、研究者和联合申办者（美国国立卫生研究院和一家制药公司）之间的关系有关。 PDMB 面临的挑战是协调内部不一致的安全性和死亡率数据，并确定其他同时运行的试验的死亡率数据的权重。协调中心在协商如何传达联合赞助试验的结果时面临着挑战。尽早解决某些组织和程序问题，例如有关缺席投票的规则、监督委员会应向哪个机构正式报告以及传播不同类型结果的时间和一般内容，将使联合主办的试验在最后时刻更能应对困难。 (C) 2003 Elsevier Science Inc. 保留所有权利。
We report on two features of the early termination of the Studies of Ocular Complications of AIDS Monoclonal Antibody Cytomegalovirus Retinitis Trial: one related to the deliberative process of the treatment effects monitoring body (the policy and data monitoring board [PDMB]) and the other related to the relationships among the PDMB, the investigators, and the joint sponsors (the National Institutes of Health and a pharmaceutical company). The PDMB was challenged with reconciling internally inconsistent safety and mortality data and determining the weight to give mortality data from other concurrently running trials. The coordinating center faced a challenge in negotiating how to communicate results from a jointly sponsored trial. Early resolution of certain organizational and procedural issues, such as rules regarding absentee voting, to which body the monitoring committee should report officially, and the timing and general content of dissemination of different kinds of results, would make jointly sponsored trials more robust to difficulties at the final hour. (C) 2003 Elsevier Science Inc. All rights reserved.