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Tytuł:
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Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials.
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Autorzy:
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Joffe S; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Babiker A; Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
Ellenberg SS; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Fix A; Center for Vaccine Innovation and Access, PATH, Washington, District of Columbia, USA.
Griffin MR; Vanderbilt School of Medicine, Nashville, Tennessee, USA.
Hunsberger S; National Institute of Allergy and Infectious Disease, Rockville, Maryland, USA.
Kalil J; Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Levine MM; University of Maryland School of Medicine, Baltimore, Maryland, USA.
Makgoba MW; Health Ombudsman, Office of Health Standards and Compliance, Pretoria, Republic of South Africa.
Moore RH; Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
Tsiatis AA; North Carolina State University, Raleigh, North Carolina, USA.
Whitley R; University of Alabama at Birmingham, Birmingham, Alabama, USA.
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Źródło:
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The Journal of infectious diseases [J Infect Dis] 2021 Dec 15; Vol. 224 (12), pp. 1995-2000.
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Typ publikacji:
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Journal Article; Research Support, N.I.H., Extramural; Review
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Język:
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English
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Imprint Name(s):
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Publication: Jan. 2011- : Oxford : Oxford University Press
Original Publication: 1904-2010 : Chicago, IL : University of Chicago Press
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MeSH Terms:
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COVID-19/*prevention & control
COVID-19 Vaccines/*adverse effects
COVID-19 Vaccines/*immunology
Aged ; COVID-19 Vaccines/administration & dosage ; Humans ; SARS-CoV-2 ; United States ; Vaccines
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References:
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Nature. 2020 Aug;584(7821):353-363. (PMID: 32659783)
Sci Transl Med. 2020 Sep 23;12(562):. (PMID: 32887789)
Hum Vaccin Immunother. 2019;15(10):2295-2314. (PMID: 31589551)
N Engl J Med. 2021 May 20;384(20):1965-1966. (PMID: 33861522)
N Engl J Med. 2020 Oct 29;383(18):1701-1703. (PMID: 32846056)
Science. 2020 May 29;368(6494):948-950. (PMID: 32393526)
Vaccine. 2016 Mar 29;34(14):1643-7. (PMID: 26873054)
Control Clin Trials. 1995 Dec;16(6):408-21. (PMID: 8720018)
Am J Epidemiol. 1969 Apr;89(4):435-48. (PMID: 4305199)
Science. 2020 May 29;368(6494):945-946. (PMID: 32385100)
Am J Epidemiol. 1969 Apr;89(4):422-34. (PMID: 4305198)
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Contributed Indexing:
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Keywords: COVID19; SARS-CoV-2; clinical trials; data and safety monitoring; vaccines
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Substance Nomenclature:
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0 (COVID-19 Vaccines)
0 (Vaccines)
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Entry Date(s):
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Date Created: 20210519 Date Completed: 20220107 Latest Revision: 20220107
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Update Code:
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20240104
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PubMed Central ID:
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PMC8240876
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DOI:
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10.1093/infdis/jiab263
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PMID:
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34008027
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To speed the development of vaccines against SARS-CoV-2, the United States Federal Government has funded multiple phase 3 trials of candidate vaccines. A single 11-member data and safety monitoring board (DSMB) monitors all government-funded trials to ensure coordinated oversight, promote harmonized designs, and allow shared insights related to safety across trials. DSMB reviews encompass 3 domains: (1) the conduct of trials, including overall and subgroup accrual and data quality and completeness; (2) safety, including individual events of concern and comparisons by randomized group; and (3) interim analyses of efficacy when event-driven milestones are met. Challenges have included the scale and pace of the trials, the frequency of safety events related to the combined enrollment of over 100 000 participants, many of whom are older adults or have comorbid conditions that place them at independent risk of serious health events, and the politicized environment in which the trials have taken place.
(Published by Oxford University Press for the Infectious Diseases Society of America 2021.)
Comment in: J Infect Dis. 2021 Dec 15;224(12):1993-1994. (PMID: 34007981)
