University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Clin Infect Dis. 2021 Mar 15;72(6):1093-1100. doi: 10.1093/cid/ciaa1231.
There is a proliferation of clinical trials worldwide to find effective therapies for patients diagnosed with coronavirus disease 2019 (COVID-19). The endpoints that are currently used to evaluate the efficacy of therapeutic agents against COVID-19 are focused on clinical status at a particular day or on time to a specific change of clinical status. To provide a full picture of the clinical course of a patient and make complete use of available data, we consider the trajectory of clinical status over the entire follow-up period. We also show how to combine the evidence of treatment effects on the occurrences of various clinical events. We compare the proposed and existing endpoints through extensive simulation studies. Finally, we provide guidelines on establishing the benefits of treatments.
目前,全球范围内有大量临床试验旨在为诊断为 2019 冠状病毒病(COVID-19)的患者寻找有效疗法。目前,用于评估治疗 COVID-19 药物疗效的终点主要集中在特定日期的临床状况或特定临床状况变化的时间上。为了全面了解患者的临床过程并充分利用现有数据,我们考虑了整个随访期间的临床状况轨迹。我们还展示了如何结合治疗对各种临床事件发生的影响的证据。我们通过广泛的模拟研究比较了提出的和现有的终点。最后,我们提供了关于确立治疗益处的指南。