Statistical Aspects Of COVID-19 Vaccine Trials

September 30, 2020

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 Follman will first give a brief overview of the OWS landscape, including 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.



Speaker: Dean Follman, PhD, Assistant Director for Biostatistics, NIAIDChief Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases



Event Type: 
Biostatistics and Bioinformatics Seminar