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ACTIV试验特定经验教训概述。

Overview of ACTIV trial-specific lessons learned.

作者信息

Draghia-Akli Ruxandra, Read Sarah W, Hughes Eric A

机构信息

The Janssen Pharmaceutical Companies of Johnson & Johnson, Spring House, PA, USA.

National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.

出版信息

J Clin Transl Sci. 2024 Oct 15;8(1):e149. doi: 10.1017/cts.2023.698. eCollection 2024.

DOI:10.1017/cts.2023.698
PMID:39478781
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11523021/
Abstract

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) was an extraordinary example of a public-private partnership (PPP) that brought together over thirty organizations and hundreds of individuals to address one of the most pressing global health needs in recent decades. In particular, ACTIV provided a key avenue for testing numerous therapeutics for their potential benefit in treating the SARS-CoV-2 virus or the resulting symptoms of acute COVID-19 infection. Given the speed and scale at which ACTIV designed and implemented master protocols across global networks that it was simultaneously working to create, the PPP can provide valuable lessons for best practices and avoiding pitfalls the next time the world is faced with a global pandemic of a novel pathogen. This report provides a general overview of the ACTIV partnership to set the stage and context for the subsequent articles in this issue that will relay these lessons learned.

摘要

加速COVID-19治疗干预和疫苗(ACTIV)是公私合作伙伴关系(PPP)的一个非凡范例,它汇聚了三十多个组织和数百名个人,以应对近几十年来最紧迫的全球卫生需求之一。特别是,ACTIV提供了一条关键途径,用于测试多种疗法在治疗SARS-CoV-2病毒或急性COVID-19感染所产生症状方面的潜在益处。鉴于ACTIV在其同时努力创建的全球网络中设计和实施主方案的速度和规模,这种公私合作伙伴关系可为最佳实践提供宝贵经验教训,并在世界下次面临新型病原体全球大流行时避免陷入困境。本报告对ACTIV合作伙伴关系进行了总体概述,为本期后续文章介绍这些经验教训奠定基础并提供背景。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d1a/11523021/787628ce9f0a/S2059866123006982_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d1a/11523021/5fd49d85db9a/S2059866123006982_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d1a/11523021/751eb6f0e660/S2059866123006982_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d1a/11523021/34f01e715278/S2059866123006982_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d1a/11523021/787628ce9f0a/S2059866123006982_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d1a/11523021/5fd49d85db9a/S2059866123006982_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d1a/11523021/751eb6f0e660/S2059866123006982_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d1a/11523021/34f01e715278/S2059866123006982_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d1a/11523021/787628ce9f0a/S2059866123006982_fig4.jpg

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JAMA. 2023 Mar 21;329(11):888-897. doi: 10.1001/jama.2023.1650.
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Thromboprophylactic low-molecular-weight heparin versus standard of care in unvaccinated, at-risk outpatients with COVID-19 (ETHIC): an open-label, multicentre, randomised, controlled, phase 3b trial.COVID-19 未接种疫苗、有风险的门诊患者中预防性使用低分子肝素与标准治疗的比较(ETHIC):一项开放标签、多中心、随机、对照、3b 期临床试验。
Lancet Haematol. 2022 Aug;9(8):e594-e604. doi: 10.1016/S2352-3026(22)00173-9. Epub 2022 Jun 30.
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R&D during public health emergencies: the value(s) of trust, governance and collaboration.
公共卫生突发事件中的研发:信任、治理与合作的价值。
BMJ Glob Health. 2022 Mar;7(3). doi: 10.1136/bmjgh-2021-007873.
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