Program in Ethics and Policy, Center for Biomedical Ethics and Humanities, University of Virginia School of Medicine, Charlottesville, Virginia 22908, USA.
Account Res. 2011 Jan;18(1):1-30. doi: 10.1080/08989621.2011.542680.
There is little to no empirical data available on how data and safety monitoring boards (DSMBs) are structured and how they operate. The purpose of this study was to provide data on this. To accomplish this goal, we administered a random survey on current structure and management practices and opinions as reported by principal investigators (PIs) and biostatisticians. We also surveyed Institutional Review Board (IRB) community members, as proxies for the public, as to their opinions on how DSMBs should be structured and managed. A final purpose was to compare opinions about what should be taking place to what is actually happening.
关于数据和安全监测委员会（DSMB）的结构和运作方式，几乎没有可用的经验数据。本研究的目的是提供这方面的数据。为了实现这一目标，我们对主要研究者（PI）和生物统计学家报告的当前结构和管理实践以及意见进行了随机调查。我们还调查了机构审查委员会（IRB）的社区成员，作为公众的代表，了解他们对 DSMB 结构和管理的意见。最后一个目的是比较对应该发生的事情和实际发生的事情的看法。
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