Meta-analysis in regulatory practice
*Tom Hammerstrom, FDA 

Keywords: meta-analysis, non-inferiority, atazanavir, NDA

Analysis of non-inferiority trials involves a special case of meta-analysis. We will show how information from several NDAs can be combined to help decide whether a new compound is superior to placebo, in the absence of a single trial containing both the new compound and placebo arms. We will illustrate this with data from the atazanavir NDA.