NIAID/DIVISION OF AIDS (DAIDS) DATA AND SAFETY MONITORING BOARD (DSMB) MEETING SUPPORT

自1979年以来，NIH的政策要求所有多中心第三阶段试验都有独立的数据和安全监测委员会(DSMB)；最近一次重述是在1998年发布的(NIH数据和安全监测政策，NIH指南公告98-084)。2000年提供了NIH对第一阶段和第二阶段试验的进一步指导(NIH关于第一阶段和第二阶段试验的数据A数据和安全监测的进一步指导，NIH指南公告OD-00-038)。鉴于联邦法规(45 CFR 46)分配给地方机构审查委员会(IRB)的相关监测责任，NIH在1999年增加了一项要求，即即使没有建议进行重大改变，也应通知地方机构审查委员会所有DSMB审查的结果，以记录数据和安全监测正在按预期发生(NIH支持的多中心临床试验向机构审查委员会报告不良事件的指南，NIH指南通知99-107)。NIH的这些政策没有解决执行问题，将这些问题留给了各个研究所和中心。因此，国家过敏和传染病研究所(NIAID)发布了自己的关于DSMB操作基本原则的政策。艾滋病司(DAIDS)主要通过常设DSMB监测多中心随机临床试验的安全性和有效性。

NIH policy requiring independent data and safety monitoring boards (DSMB) for all multicenter Phase III trials has existed since 1979; the most recent restatement was issued in 1998 (NIH Policy for Data and Safety Monitoring, NIH Guide Notice 98-084). Further NIH guidance for Phase I and II trials was provided in 2000 (Further NIH Guidance on Data A Data and Safety Monitoring for Phase I and Phase II Trials, NIH Guide Notice OD-00-038). In light of the related responsibility for monitoring assigned to local Institutional Review Boards (IRB) by federal regulation (45 CFR 46), NIH added a requirement in 1999 that local IRBs be notified of the outcome of all DSMB reviews, even when no major change has been recommended, to document that data and safety monitoring is occurring as expected (Guidance on Reporting Adverse Events to Institutional Review Boards for NIH-Supported Multicenter Clinical Trials, NIH Guide Notice 99-107). These NIH policies do not address implementation matters, leaving those to individual Institutes and Centers. As a result, the National Institute of Allergy and Infectious Diseases (NIAID) has issued its own policy on basic principles for DSMB operations. The Division of AIDS (DAIDS) monitors safety and efficacy of multicenter randomized clinical trials primarily through standing DSMBs.