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.
翻译:作为对严重急性呼吸系统综合症冠状病毒2(SARS-COV-2)流行病的反应,治疗SARS-COV-2或由此产生的冠状腺病(COVID-19)的大量临床试验从规划到完成全球处于不同阶段,虽然已作出一些努力,使研究设计标准化,但由于该流行病的凶猛性以及迅速进行试验的需要,这受到阻碍。我们认为,成功治疗COVID-19病人(一) 增加在一定时间间隔内恢复或改进的可能性,例如28天;(二) 力求在这一时间框架内加快有利的事件;(三) 在此期间不增加死亡率。在此背景下,我们讨论终点的选择及其分析。此外,我们考虑这一选择对其他设计的影响,包括抽样规模和权力,并就在这一特定情况下应用适应性设计提供一些指导。