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数据监测委员会:是一个集体还是一个集合?

The Data Monitoring Committee: A Collective or a Collection?

机构信息

Wittes LLC, Washington, DC, USA.

University of Washington, Seattle, WA, USA.

出版信息

Ther Innov Regul Sci. 2023 Jul;57(4):653-655. doi: 10.1007/s43441-023-00520-6. Epub 2023 Apr 17.

Abstract

In this commentary, we urge that a Data Monitoring Committee (DMC) should operate as a collective, that is, as a unitary whole. In so doing, its recommendations should emerge through a consensus development process, not through a vote of the members. The summary notes of its closed session, that is, its minutes, should report the recommendations of the DMC and, if necessary, the justification for those recommendations; it should not attribute opinions to individual members. Importantly, the proceedings of the DMC meetings should not be electronically recorded.

摘要

在这篇评论中,我们强烈主张数据监测委员会(DMC)应该作为一个整体运作,也就是说,作为一个统一的整体。这样,它的建议应该通过共识发展过程产生,而不是通过成员投票。其闭门会议的简要记录,即其会议记录,应报告 DMC 的建议,如果有必要,还应报告这些建议的理由;不应将意见归因于个别成员。重要的是,DMC 会议的议事过程不应进行电子记录。

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