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新冠疫情期间药物研发面临的挑战:临床试验设计的关键考虑因素。

Challenges of drug development during the COVID-19 pandemic: Key considerations for clinical trial designs.

机构信息

dMed, Shanghai, China.

Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.

出版信息

Br J Clin Pharmacol. 2021 May;87(5):2170-2185. doi: 10.1111/bcp.14629. Epub 2020 Dec 10.

DOI:10.1111/bcp.14629
PMID:33119136
Abstract

There is an urgent need for targeted and effective COVID-19 treatments. Several medications, including hydroxychloroquine, remdesivir, lopinavir-ritonavir, favipiravir, tocilizumab and others have been identified as potential treatments for COVID-19. Bringing these repurposed medications to the public for COVID-19 requires robust and high-quality clinical trials that must be conducted under extremely challenging pandemic conditions. This article reviews translational science principles and strategies for conducting clinical trials in a pandemic and evaluates recent trials for different drug candidates. We hope that this knowledge will help focus efforts during this crisis and lead to the expedited development and approval of COVID-19 therapies.

摘要

目前迫切需要有针对性且有效的 COVID-19 治疗方法。几种药物,包括羟氯喹、瑞德西韦、洛匹那韦/利托那韦、法匹拉韦、托珠单抗等,已被确定为 COVID-19 的潜在治疗方法。将这些重新定位的药物推向公众用于 COVID-19 需要进行强有力的高质量临床试验,而这些临床试验必须在极其具有挑战性的大流行条件下进行。本文回顾了在大流行期间进行临床试验的转化科学原则和策略,并评估了最近针对不同候选药物的临床试验。我们希望这些知识将有助于在这场危机中集中精力,并加速 COVID-19 疗法的开发和批准。

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