DeMets D L, Fleming T R, Whitley R J, Childress J F, Ellenberg S S, Foulkes M, Mayer K H, O'Fallon J, Pollard R B, Rahal J J
Department of Biostatistics, University of Wisconsin Medical School, Madison 53792, USA.
Control Clin Trials. 1995 Dec;16(6):408-21. doi: 10.1016/s0197-2456(95)00073-9.
The urgency of the Acquired immune deficiency syndrome (AIDS) epidemic has mandated that multiple therapeutic approaches be developed and that these approaches be evaluated through clinical trials. To oversee these trials, the National Institute of Allergy and Infectious Diseases (NIAID) has created three large clinical trial programs monitored by a Data and Safety Monitoring Board (DSMB). For each clinical trial, this Board uses a standardized approach employing contemporary biostatistical, medical, and ethical principles. The DSMB is responsible for reviewing interim data on clinical trial performance, treatment safety and efficacy, and overall study progress. If interim results provide convincing evidence of either excessive adverse effects or significant treatment benefit, the DSMB may recommend early termination of the trial to the NIAID and the study investigators. The responsibility, organization, and operating procedures of this DSMB are presented and illustrated through three clinical trials sponsored by NIAID and monitored by the Board. The rationale and operational model for the DSMB may be a useful example for the development of similar review processes in other HIV clinical trial settings.
获得性免疫缺陷综合征（艾滋病）疫情的紧迫性要求开发多种治疗方法，并通过临床试验对这些方法进行评估。为监督这些试验，美国国立过敏与传染病研究所（NIAID）设立了三个大型临床试验项目，由数据与安全监测委员会（DSMB）进行监测。对于每项临床试验，该委员会采用一种标准化方法，运用当代生物统计学、医学和伦理原则。DSMB负责审查关于临床试验表现、治疗安全性和疗效以及总体研究进展的中期数据。如果中期结果提供了令人信服的证据，证明存在过度不良反应或显著治疗益处，DSMB可能会建议NIAID和研究调查人员提前终止试验。通过NIAID赞助并由该委员会监测的三项临床试验，介绍并说明了DSMB的职责、组织和操作程序。DSMB的基本原理和运作模式可能为其他HIV临床试验环境中类似审查流程的发展提供一个有用的范例。
