Tytuł pozycji:
US FDA erratic approach to placebo-controlled trials after issuing an emergency use authorization for a COVID-19 vaccine.
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Tytuł:
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US FDA erratic approach to placebo-controlled trials after issuing an emergency use authorization for a COVID-19 vaccine.
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Autorzy:
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Dal-Ré R; Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain. Electronic address: .
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Źródło:
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Vaccine [Vaccine] 2021 Feb 22; Vol. 39 (8), pp. 1180-1182. Date of Electronic Publication: 2021 Jan 20.
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Typ publikacji:
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Journal Article
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Język:
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English
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Imprint Name(s):
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Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
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MeSH Terms:
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COVID-19 Vaccines*
United States Food and Drug Administration*
COVID-19/*prevention & control
Drug Approval/*methods
Randomized Controlled Trials as Topic/*standards
Clinical Trials, Phase III as Topic ; Humans ; Randomized Controlled Trials as Topic/ethics ; United States
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References:
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Clin Pharmacol Ther. 2008 May;83(5):788-93. (PMID: 17882160)
JAMA. 2020 Aug 4;324(5):437-438. (PMID: 32628244)
Lancet Respir Med. 2021 Apr;9(4):e30-e31. (PMID: 33476582)
N Engl J Med. 2020 Oct 29;383(18):1701-1703. (PMID: 32846056)
Ann Intern Med. 2021 Feb;174(2):258-260. (PMID: 33216636)
N Engl J Med. 2020 Nov 5;383(19):e107. (PMID: 33064383)
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Contributed Indexing:
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Keywords: COVID-19; Candidate vaccines; Clinical trials; Emergency use authorization; Expanded access; FDA; Phase 3 trials; SARS-CoV-2
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Substance Nomenclature:
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0 (COVID-19 Vaccines)
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Entry Date(s):
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Date Created: 20210131 Date Completed: 20210224 Latest Revision: 20221221
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Update Code:
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20240104
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PubMed Central ID:
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PMC7817401
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DOI:
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10.1016/j.vaccine.2021.01.050
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PMID:
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33516602
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Competing Interests: Declaration of Competing Interest The author declare that he has no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.