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[拉丁美洲和加勒比地区的COVID-19临床试验概况:评估与挑战]

[The landscape of COVID-19 clinical trials in Latin America and the Caribbean: assessment and challenges].

作者信息

Carracedo Sarah, Palmero Ana, Neil Marcie, Hasan-Granier Anisa, Saenz Carla, Reveiz Ludovic

机构信息

Organización Panamericana de la Salud Washington, D.C. Estados Unidos de América Organización Panamericana de la Salud, Washington, D.C., Estados Unidos de América.

出版信息

Rev Panam Salud Publica. 2021 Mar 8;45:e33. doi: 10.26633/RPSP.2021.33. eCollection 2021.

DOI:10.26633/RPSP.2021.33
PMID:33708248
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7939030/
Abstract

A considerable number of clinical trials is being conducted globally in response to the COVID-19 pandemic, including in low- and middle-income countries such as those in the Latin America and Caribbean region (LAC). Yet, an abundance of studies does not necessarily shorten the path to find safe and efficacious interventions for COVID-19. We analyze the trials for COVID-19 treatment and prevention that are registered from LAC countries in the International Clinical Trials Registry Platform, and identify a trend towards small repetitive non-rigorous studies that duplicate efforts and drain limited resources without producing meaningful conclusions on the safety and efficacy of the interventions being tested. We further assess the challenges to conducting scientifically sound and socially valuable research in the LAC region in order to inform recommendations to encourage clinical trials that are most likely to produce robust evidence during the pandemic.

摘要

为应对新冠疫情,全球正在进行大量临床试验,包括在拉丁美洲和加勒比地区(LAC)等低收入和中等收入国家。然而,大量的研究并不一定能缩短找到针对新冠病毒安全有效干预措施的路径。我们分析了在国际临床试验注册平台上注册的来自拉丁美洲和加勒比地区国家的新冠治疗和预防试验,发现存在一种趋势,即小型重复性非严格研究不断出现,这些研究重复劳动,耗尽有限资源,却未能就所测试干预措施的安全性和有效性得出有意义的结论。我们进一步评估了在拉丁美洲和加勒比地区开展科学合理且具有社会价值研究面临的挑战,以便提出建议,鼓励开展在疫情期间最有可能产生有力证据的临床试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c2bb/7939030/9a915b7c6a4b/rpsp-45-e33_Figure1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c2bb/7939030/9a915b7c6a4b/rpsp-45-e33_Figure1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c2bb/7939030/9a915b7c6a4b/rpsp-45-e33_Figure1.jpg

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本文引用的文献

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Clinical Trials for COVID-19: Can we Better Use the Short Window of Opportunity?COVID-19 临床试验:我们能否更好地利用短暂的机会窗口?
Clin Pharmacol Ther. 2020 Oct;108(4):730-733. doi: 10.1002/cpt.1891. Epub 2020 Jun 12.
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Inclusion of Children in Clinical Trials of Treatments for Coronavirus Disease 2019 (COVID-19).将儿童纳入2019冠状病毒病(COVID-19)治疗的临床试验
JAMA Pediatr. 2020 Sep 1;174(9):825-826. doi: 10.1001/jamapediatrics.2020.1888.
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Against pandemic research exceptionalism.反对大流行研究例外论。
Characterising COVID-19 empirical research production in Latin America and the Caribbean: A scoping review.
描绘拉丁美洲和加勒比地区 COVID-19 实证研究成果的特征:范围综述。
PLoS One. 2022 Feb 16;17(2):e0263981. doi: 10.1371/journal.pone.0263981. eCollection 2022.
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Pregnancy outcomes in interferon-beta-exposed patients with multiple sclerosis: results from the European Interferon-beta Pregnancy Registry.多发性硬化症干扰素-β暴露患者的妊娠结局:来自欧洲干扰素-β妊娠登记处的结果。
J Neurol. 2020 Jun;267(6):1715-1723. doi: 10.1007/s00415-020-09762-y. Epub 2020 Feb 26.
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A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.埃博拉病毒病治疗的随机、对照试验。
N Engl J Med. 2019 Dec 12;381(24):2293-2303. doi: 10.1056/NEJMoa1910993. Epub 2019 Nov 27.
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Adherence to clinical trial registration in countries of Latin America and the Caribbean, 2015.2015年拉丁美洲和加勒比地区各国临床试验注册的依从情况
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