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; Levine, Myron M et al. · NEJM Evid · 2023

review · Level V

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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.

Medical subject headings