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Creating a Framework for Conducting Randomized Clinical Trials during Disease Outbreaks.创建疾病爆发期间进行随机临床试验的框架。
N Engl J Med. 2020 Apr 2;382(14):1366-1369. doi: 10.1056/NEJMsb1905390.
2
Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory.在试验方案和相应出版物中关于盲法的报告往往不充分,但很少相互矛盾。
J Clin Epidemiol. 2009 Sep;62(9):967-73. doi: 10.1016/j.jclinepi.2009.04.003.
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CONSORT statement: extension to cluster randomised trials.CONSORT声明:群组随机试验扩展版
BMJ. 2004 Mar 20;328(7441):702-8. doi: 10.1136/bmj.328.7441.702.
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CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.CONSORT 2010 声明:平行组随机试验报告的更新指南。
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Developing a reporting guideline for social and psychological intervention trials.制定社会心理干预试验报告指南。
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[Quality assessment of therapeutic clinical trials].[治疗性临床试验的质量评估]
Internist (Berl). 2000 Apr;41(4):344-8. doi: 10.1007/s001080050516.
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Conducting randomized trials in the prehospital setting.在院前环境中开展随机试验。
Prehosp Emerg Care. 2002 Apr-Jun;6(2 Suppl):S38-47. doi: 10.3109/10903120209102681.
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Introduction to the series "Best (but Oft-Forgotten) Practices".“最佳(但常被遗忘)实践”系列介绍。
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Assessing blinding in randomised controlled trials of acupuncture: challenges and recommendations.评估针灸随机对照试验中的盲法:挑战与建议。
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J Clin Endocrinol Metab. 2008 Oct;93(10):3733-4. doi: 10.1210/jc.2008-1810.

引用本文的文献

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Salvaging information from paused or stopped clinical studies.从暂停或终止的临床研究中挽救信息。
Clin Trials. 2025 Jul 12:17407745251353429. doi: 10.1177/17407745251353429.
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Improving clinical care of patients in Nipah outbreaks: moving beyond 'compassionate use'.改善尼帕病毒疫情中患者的临床护理:超越“同情用药”。
Lancet Reg Health Southeast Asia. 2025 Jan 3;33:100527. doi: 10.1016/j.lansea.2024.100527. eCollection 2025 Feb.
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Why were so few randomized trials of public health and social measures conducted during the COVID-19 pandemic? The Norwegian experience.为什么在 COVID-19 大流行期间进行的公共卫生和社会措施的随机试验如此之少?挪威的经验。
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A mathematical model of Marburg virus disease outbreaks and the potential role of vaccination in control.马尔堡病毒病疫情的数学模型与疫苗接种控制的潜在作用。
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Emergence of Marburg virus: a global perspective on fatal outbreaks and clinical challenges.马尔堡病毒的出现:关于致命疫情及临床挑战的全球视角
Front Microbiol. 2023 Sep 13;14:1239079. doi: 10.3389/fmicb.2023.1239079. eCollection 2023.
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Observational studies must be reformed before the next pandemic.在下一次大流行之前,观察性研究必须进行改革。
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Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow.为下一次大流行做准备:今日的伦理与创新,铸就明日更好的临床试验。
Stat Biopharm Res. 2022;14(1):22-27. doi: 10.1080/19466315.2021.1918236. Epub 2021 Jun 1.
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Considering Risks to Researchers and Staff in Low-Resource Settings during Public Health Crises: A Proposed Conceptual Model.公共卫生危机期间低资源环境下研究人员和工作人员面临的风险:一个概念模型建议
Children (Basel). 2023 Feb 26;10(3):463. doi: 10.3390/children10030463.
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An introduction to the Marburg virus vaccine consortium, MARVAC.马尔堡病毒疫苗联盟(MARVAC)简介。
PLoS Pathog. 2022 Oct 13;18(10):e1010805. doi: 10.1371/journal.ppat.1010805. eCollection 2022 Oct.

本文引用的文献

1
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.
2
Design of vaccine efficacy trials during public health emergencies.突发公共卫生事件下疫苗效力试验的设计。
Sci Transl Med. 2019 Jul 3;11(499). doi: 10.1126/scitranslmed.aat0360.
3
The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An Evaluation of rVSV∆G-ZEBOV-GP Vaccine Tolerability and Safety During the West Africa Ebola Outbreak.塞拉利昂引入埃博拉疫苗试验:在西非埃博拉疫情期间评估 rVSV∆G-ZEBOV-GP 疫苗的耐受性和安全性。
J Infect Dis. 2018 May 18;217(suppl_1):S6-S15. doi: 10.1093/infdis/jiy020.
4
Lassa fever.拉沙热
BMJ. 2017 Jul 12;358:j2986. doi: 10.1136/bmj.j2986.
5
Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both.用于研究多种疗法、多种疾病或两者兼有的主方案。
N Engl J Med. 2017 Jul 6;377(1):62-70. doi: 10.1056/NEJMra1510062.
6
WHO R&D Blueprint: a global coordination mechanism for R&D preparedness.世界卫生组织研发蓝图:研发准备的全球协调机制。
Lancet. 2017 Jun 24;389(10088):2469-2470. doi: 10.1016/S0140-6736(17)31635-5.
7
Data monitoring committees: Promoting best practices to address emerging challenges.数据监测委员会:推广应对新出现挑战的最佳实践。
Clin Trials. 2017 Apr;14(2):115-123. doi: 10.1177/1740774516688915. Epub 2017 Feb 1.
8
A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection.ZMapp治疗埃博拉病毒感染的随机对照试验。
N Engl J Med. 2016 Oct 13;375(15):1448-1456. doi: 10.1056/NEJMoa1604330.
9
Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges.在利比里亚埃博拉疫情期间开展埃博拉病毒病疫苗临床试验:设计、流程及挑战
Clin Trials. 2016 Feb;13(1):49-56. doi: 10.1177/1740774515621037. Epub 2016 Jan 14.
10
Issues in data monitoring and interim analysis of trials.试验数据监测与中期分析中的问题。
Health Technol Assess. 2005 Mar;9(7):1-238, iii-iv. doi: 10.3310/hta9070.

Creating a Framework for Conducting Randomized Clinical Trials during Disease Outbreaks.

作者信息

Dean Natalie E, Gsell Pierre-Stéphane, Brookmeyer Ron, Crawford Forrest W, Donnelly Christl A, Ellenberg Susan S, Fleming Thomas R, Halloran M Elizabeth, Horby Peter, Jaki Thomas, Krause Philip R, Longini Ira M, Mulangu Sabue, Muyembe-Tamfum Jean-Jacques, Nason Martha C, Smith Peter G, Wang Rui, Henao-Restrepo Ana M, De Gruttola Victor

机构信息

From the Department of Biostatistics, University of Florida, Gainesville (N.E.D., I.M.L.); the World Health Organization, Geneva (P.-S.G., A.M.H.-R.); the Department of Biostatistics, University of California, Los Angeles (R.B.); the Department of Biostatistics, Yale University, New Haven, CT (F.W.C.); the Department of Statistics (C.A.D.) and the Centre for Tropical Medicine and Global Health (P.H.), University of Oxford, Oxford, the Medical Research Council (MRC) Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, Imperial College London (C.A.D.), and the MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine (P.G.S.), London, and the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.) - all in the United Kingdom; the Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (S.S.E.); the Department of Biostatistics, University of Washington (T.R.F., M.E.H.), and the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (M.E.H.) - both in Seattle; the Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring (P.R.K.), and the Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda (M.C.N.) - both in Maryland; Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of Congo (S.M., J.-J.M.-T.); and the Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute (R.W.), and the Department of Biostatistics, Harvard T.H. Chan School of Public Health (R.W., V.D.G.) - both in Boston.

出版信息

N Engl J Med. 2020 Apr 2;382(14):1366-1369. doi: 10.1056/NEJMsb1905390.

DOI:10.1056/NEJMsb1905390
PMID:
32242365
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7490833/
Abstract
摘要