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Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job.
Annals of Internal Medicine ( IF 19.6 ) Pub Date : 2019-11-19 , DOI: 10.7326/m19-1491
Scott R Evans 1 , Robert Bigelow 2 , Christy Chuang-Stein 3 , Susan S Ellenberg 4 , Paul Gallo 5 , Weili He 6 , Qi Jiang 7 , Frank Rockhold 8
Affiliation  

Data monitoring committees (DMCs), or data and safety monitoring boards, protect clinical trial participants by conducting benefit-risk assessments during the course of a clinical trial. These evaluations may be improved by broader access to data and more effective analyses and presentation. Data monitoring committees should have access to all data, including efficacy data, at each interim review. The DMC reports should include graphical presentations that summarize benefits and harms in efficient ways. Benefit-risk assessments should include summaries that are consistent with the intention-to-treat principle and have a pragmatic focus. This article provides examples of graphical summaries that integrate benefits and harms, and proposes that such summaries become standard in DMC reports.

中文翻译:

呈现风险和收益:帮助数据监视委员会做好工作。

数据监控委员会(DMC)或数据和安全监控委员会通过在临床试验过程中进行利益风险评估来保护临床试验参与者。通过更广泛地访问数据以及更有效的分析和表示,可以改善这些评估。每次临时审查时,数据监测委员会都应可以访问所有数据,包括功效数据。DMC报告应包括图形化的演示,以有效的方式总结利弊。利益风险评估应包括与意向性治疗原则相一致且以务实为重点的摘要。本文提供了综合了利弊的图形摘要的示例,并建议此类摘要成为DMC报告中的标准。
更新日期:2019-11-20
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