论文标题
评估Covid-19的临床试验的数据监测委员会
Data monitoring committees for clinical trials evaluating treatments of COVID-19
论文作者
论文摘要
2019年12月报道了2019年冠状病毒病（Covid-19）的第一批病例，世界卫生组织在2020年3月宣布SARS-COV-2的爆发被宣布为大流行。这引发了对SARS-COV-2的诊断和疫苗接种的大量研究，以及Covid-19的治疗方法。由于COVID-19是一种与高死亡率有关的严重疾病，因此该疾病中的临床试验应由数据监测委员会（DMC）（也称为数据安全监测委员会（DSMB））监测。此迹象中的DMC面临许多挑战，包括需要迅速招募，需要异常高的安全审查，更频繁地使用复杂的设计以及几乎没有对该疾病的经验。在本文中，我们提供了DMC的工作的观点，用于COVID-19的临床试验。更具体地说，我们讨论了为COVID-19试验设置和运行DMC的组织方面，尤其是针对具有更复杂设计的试验，例如平台试验或自适应设计。此外，还考虑了监测COVID-19的临床试验的统计方面。关于数据的介绍，停止安全监控规则以及使用外部数据的使用，提出了一些建议。在COVID-19的临床试验中，评估了所提出的停止边界。
The first cases of coronavirus disease 2019 (COVID-19) were reported in December 2019 and the outbreak of SARS-CoV-2 was declared a pandemic in March 2020 by the World Health Organization. This sparked a plethora of investigations into diagnostics and vaccination for SARS-CoV-2, as well as treatments for COVID-19. Since COVID-19 is a severe disease associated with a high mortality, clinical trials in this disease should be monitored by a data monitoring committee (DMC), also known as data safety monitoring board (DSMB). DMCs in this indication face a number of challenges including fast recruitment requiring an unusually high frequency of safety reviews, more frequent use of complex designs and virtually no prior experience with the disease. In this paper, we provide a perspective on the work of DMCs for clinical trials of treatments for COVID-19. More specifically, we discuss organizational aspects of setting up and running DMCs for COVID-19 trials, in particular for trials with more complex designs such as platform trials or adaptive designs. Furthermore, statistical aspects of monitoring clinical trials of treatments for COVID-19 are considered. Some recommendations are made regarding the presentation of the data, stopping rules for safety monitoring and the use of external data. The proposed stopping boundaries are assessed in a simulation study motivated by clinical trials in COVID-19.
