Eckstein Lisa
a Faculty of Law , University of Tasmania , Hobart , Australia.
Account Res. 2015;22(2):81-105. doi: 10.1080/08989621.2014.919230.
Data and Safety Monitoring Boards (DSMBs) have become an increasingly common feature of clinical trial oversight, yet a paucity of legal or ethical frameworks govern these Boards' composition or operation, or their relationship with other actors with monitoring responsibilities. This paper argues that prevailing structural gaps are impeding harmonized systems for monitoring the ongoing ethical acceptability of clinical trials. Particular tensions stem from DSMBs' sweeping discretion in deciding whether and when to recommend that a trial should be terminated or amended based on safety and efficacy information. This discretion becomes especially challenging in light of DSMBs' monopoly over emerging trial data, which prevents Institutional Review Boards, sponsors, and investigators from participating in certain pivotal and ethically charged decisions. To address these disconnects, I advocate for strengthened pre-trial and post-trial communication in addition to innovative strategies to support DSMB decision making through the life of a trial.
数据与安全监测委员会（DSMBs）已日益成为临床试验监督的常见特征，然而，却缺乏法律或伦理框架来规范这些委员会的组成、运作，或它们与其他负有监测责任的行为主体之间的关系。本文认为，当前存在的结构性缺陷正在阻碍建立统一的系统来监测临床试验持续的伦理可接受性。特别的矛盾源于DSMBs在根据安全性和有效性信息决定是否以及何时建议终止或修正试验时拥有广泛的自由裁量权。鉴于DSMBs对新出现的试验数据的垄断，这种自由裁量权变得尤其具有挑战性，因为这使得机构审查委员会、申办方和研究者无法参与某些关键且涉及伦理的决策。为解决这些脱节问题，我主张除了采取创新策略在试验全过程支持DSMB决策外，还应加强试验前和试验后的沟通。
