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首页> 外文期刊>statistics in medicine >Behind closed doors: The data monitoring board in randomized clinical trials
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Behind closed doors: The data monitoring board in randomized clinical trials

机译：闭门造车：随机临床试验中的数据监测委员会

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AbstractMany randomized clinical trials include a data and safety monitoring board (DSMB) that is responsible for reviewing accruing data, monitoring performance of the trial, assuring safety of the participants in the trial, and assessing the efficacy of treatment. The DSMB often makes recommendations about continuation of the trial or alteration of the protocol. Although such boards are very influential in both the conduct and interpretation of randomized clinical trials, there is no standard mode in which DSMBs operate nor do they routinely report publicly about their deliberations. This paper describes the composition of DSMBs as well as their functions. It concludes with a series of questions that needs to be addressed to ensure that the DSMBs operate effectively.
机译：摘要许多随机临床试验包括一个数据和安全监测委员会（DSMB），该委员会负责审查累积数据，监测试验的性能，确保试验参与者的安全，并评估治疗的疗效。DSMB 经常就继续试验或更改方案提出建议。尽管这些委员会在随机临床试验的实施和解释方面都非常有影响力，但 DSMB 没有标准的运作模式，也不会定期公开报告他们的审议情况。本文描述了DSMB的组成及其功能。它最后提出了一系列需要解决的问题，以确保DSMB有效运行。

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