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Monitoring Multiple U.S. Government–Supported Covid-19 Vaccine Trials

Hunsberger, Sally; Ellenberg, Susan S; Joffe, Steven; Babiker, Abdel; Fix, Alan; Griffin, Marie R; Kalil, Jorge; ... Whitley, Richard; + view all (2023) Monitoring Multiple U.S. Government–Supported Covid-19 Vaccine Trials. New England Journal of Medicine , 2 (3) 10.1056/EVIDctcs2200301. Green open access

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Abstract

Monitoring U.S. Government-Supported Covid-19 Vaccine TrialsOperation Warp Speed was a partnership created to accelerate the development of Covid-19 vaccines. The National Institutes of Health oversaw one data and safety monitoring board to review/monitor all Operation Warp Speed trials. This article describes the challenges faced in monitoring these trials and provides ideas for future similar endeavors.

Type: Article
Title: Monitoring Multiple U.S. Government–Supported Covid-19 Vaccine Trials
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1056/EVIDctcs2200301
Publisher version: http://dx.doi.org/10.1056/evidctcs2200301
Language: English
Additional information: This version is the version of record. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: United States, Humans, COVID-19 Vaccines, COVID-19, Clinical Trials Data Monitoring Committees, National Institutes of Health (U.S.)
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10191799
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