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Abstract:
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Operation Warp Speed (OWS) is the US government program to evaluate COVID-19 vaccine clinical trials with six different trials launched or planned. The speed, complexity, and scrutiny of the trials in our charged political environment and during a global pandemic is unprecedented. Multiple aspects of the trial require quickly yet carefully crafted statistical approaches for design, monitoring, and analysis. In this talk we give a brief overview of the OWS landscape, discussion the basic structure of vaccine clinical trials, and then provide a more in-depth workup of selected topics including monitoring for vaccine induced enhanced disease, correlating vaccine induced immune response to prevention of disease, and the consequences of a successful vaccine on the conduct of ongoing placebo-controlled trials.
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