European Medicines Agency (EMA), Amsterdam, The Netherlands.
Medical University of Vienna, Vienna, Austria.
Clin Pharmacol Ther. 2020 Oct;108(4):730-733. doi: 10.1002/cpt.1891. Epub 2020 Jun 12.
The scientific community has risen to the coronavirus disease 2019 (COVID-19) challenge, coming up with an impressive list of candidate drugs and vaccines targeting an array of pharmacological and immunological mechanisms. Yet, generating clinical evidence of efficacy and safety of these candidate treatments may be frustrated by the absence of comprehensive trial coordination mechanisms. Many small stand-alone trials and observational studies of single-agent interventions are currently running or in planning; many of these will likely not deliver robust results that could support regulatory and patient-level treatment decisions. In this paper, we discuss actions that all stakeholders in the clinical trial ecosystem need to take to ensure that the window of opportunity during this pandemic will not shut, both for patients in need of treatment and for researchers to conduct decision-relevant clinical trials.
科学界已经应对了 2019 年冠状病毒病(COVID-19)的挑战,提出了一系列令人印象深刻的候选药物和疫苗,针对各种药理学和免疫学机制。然而,由于缺乏全面的试验协调机制,这些候选治疗方法的疗效和安全性的临床证据可能会受到阻碍。目前正在进行或正在计划许多小型独立试验和单药干预的观察性研究;其中许多可能不会产生支持监管和患者层面治疗决策的可靠结果。在本文中,我们讨论了临床试验生态系统中的所有利益相关者都需要采取的行动,以确保在这场大流行期间,无论是对需要治疗的患者还是对进行相关决策的研究人员来说,机会之窗都不会关闭。