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首页> 外文期刊>The American Journal of Tropical Medicine and Hygiene >Confronting the Multidimensional Challenges of Research in the Context of Emerging Infectious Diseases in Brazil: The Example of Yellow Fever
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Confronting the Multidimensional Challenges of Research in the Context of Emerging Infectious Diseases in Brazil: The Example of Yellow Fever

机译：面对巴西新兴传染病背景下的研究多维挑战：黄热病的例子

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摘要

In the most recent Brazilian yellow fever (YF) outbreak, a group of clinicians and researchers initiated in mid-January 2018 a considerable effort to develop a multicenter randomized controlled clinical trial to evaluate the effect of sofosbuvir on YF viremia and clinical outcomes (Brazilian Clinical Trials Registry: RBR-93dp9n). The approval of this protocol had urgency given the seasonal/short-lived pattern of YF transmission, large number of human cases, and epidemic transmission at the outskirts of a large urban center. However, many intricacies in the research regulatory and ethical submission systems in Brazil were indomitable even under such pressing conditions. By April 2018, we had enrolled 29 patients for a target sample size of 90 participants. Had enrollment been initiated 3 weeks earlier, an additional 31 patients could have been enrolled, reaching the prespecified sample size for the interim analysis. This recent experience highlights the urgent need to improve local preparedness for research in the setting of explosive outbreaks, as has been seen in the last few years in different countries.
机译：在最近的巴西黄热病（YF）爆发中，一群临床医生和研究人员在2018年1月中旬开始，开发多中心随机对照临床试验，以评估Sofosbuvir对Yf毒性和临床结果的影响（巴西临床结果试验登记处：RBR-93DP9N）。本议定书的批准具有紧迫性，因为季节性/短暂的传播模式，大量人类案例和一个大城市中心郊区的疫情传播。然而，即使在这种压制条件下，巴西的研究监管和道德提交系统中的许多复杂性也是顽固的。到2018年4月，我们已向90名参与者的目标样本大小注册了29名患者。已在3周前发起注册，额外的31名患者可以纳入，达到临时分析的预先确定的样本量。这一最近的经历突出了改善爆炸性爆发中的研究的局部准备的迫切需要，正如在不同国家的过去几年中所见的那样。

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