RL04 Statistical Issues in Vaccine Research
*Jack S Nyberg, sanofi pasteur 


Although similar to pharmaceutical research, vaccine research has its own statistical issues that are not normally discussed at industry conferences and workshops. At this roundtable, I hope to discuss some of these issues (e.g., correlates of protection, superiority and super-superiority in vaccine trials, the use of adaptive design in vaccine trials, regulatory guidance vs industry constraints, assay variability and consistency, etc.) and talk about initiatives being undertaken to create venues for vaccine industry statisticians to share their knowledge.