论文标题
COVID-19治疗试验的设计方面：提高有利事件的概率和时间
Design aspects of COVID-19 treatment trials: Improving probability and time of favourable events
论文作者
论文摘要
作为对严重急性呼吸综合征冠状病毒2（SARS-COV-2）大流行的反应，这是一项用于治疗SARS-COV-2或由此导致的Corona疾病（COVID-19）的临床试验（COVID-19）在整个阶段都在计划到完成的各个阶段。尽管进行了一些尝试标准化研究设计的尝试，但这受到大流行的凶猛性和迅速进行试验的必要性的阻碍。我们认为，成功治疗Covid-19患者（i）会增加一定时间间隔内恢复或改善的可能性，例如28天； （ii）旨在加快此时间范围内的有利事件； （iii）在这段时间内不会增加死亡率。在此背景下，我们讨论了端点的选择及其分析。此外，我们考虑了此选择对包括样本量和功率在内的其他设计方面的后果，并在此特定情况下对自适应设计的应用提供了一些指导。
As a reaction to the pandemic of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a multitude of clinical trials for the treatment of SARS-CoV-2 or the resulting corona disease (COVID-19) are globally at various stages from planning to completion. Although some attempts were made to standardize study designs, this was hindered by the ferocity of the pandemic and the need to set up trials quickly. We take the view that a successful treatment of COVID-19 patients (i) increases the probability of a recovery or improvement within a certain time interval, say 28 days; (ii) aims to expedite favourable events within this time frame; and (iii) does not increase mortality over this time period. On this background we discuss the choice of endpoint and its analysis. Furthermore, we consider consequences of this choice for other design aspects including sample size and power and provide some guidance on the application of adaptive designs in this particular context.
