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

Sally Hunsberger,Susan S Ellenberg,Steven Joffe,Abdel Babiker,Alan Fix,Marie R Griffin,Jorge Kalil,Myron M Levine,Malegapuru W Makgoba,Reneé H Moore,Anastasios A Tsiatis,Richard Whitley

NEJM Evidence（2023）

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摘要

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.

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vaccine,trials,monitoring

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