埃博拉病毒病治疗试验的统计学考量
Statistical considerations for a trial of Ebola virus disease therapeutics.
作者信息
Proschan Michael A, Dodd Lori E, Price Dionne
机构信息
National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD, USA
National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD, USA.
出版信息
Clin Trials. 2016 Feb;13(1):39-48. doi: 10.1177/1740774515620145. Epub 2016 Jan 14.
Abstract
The 2014 West African outbreak of Ebola virus ravaged Liberia, Sierra Leone, and Guinea, causing hemorrhagic fever and death. The need to identify effective therapeutics was acute. The usual drug development paradigm of phase I, followed by phase II, and then phase III trials would take too long. These and other factors led to the design of a clinical trial of Ebola virus disease therapeutics that differs from more conventional clinical trial designs. This article describes the Ebola virus disease medical countermeasures trial design and the thinking behind it.
摘要
2014年西非爆发的埃博拉病毒疫情肆虐利比里亚、塞拉利昂和几内亚，引发出血热并导致死亡。识别有效治疗方法的需求极为迫切。按照通常的药物研发模式，先进行一期试验，接着是二期试验，然后是三期试验，这耗时过长。这些因素以及其他因素促使人们设计了一项针对埃博拉病毒病治疗方法的临床试验，该试验与更为传统的临床试验设计有所不同。本文描述了埃博拉病毒病医疗对策试验的设计及其背后的思路。
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