Sample size for equivalence trials: A case study from a vaccines lot consistency trial
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Alessandra Anemona, Novartis  *Jitendra Ganju, Amgen  Allen Izu, Novartis 

Keywords: sample size, power, equivalence trials

For some trials simple but subtle assumptions can have a profound impact on the size of the trial. A case in point is a vaccine lot consistency (or equivalence) trial. Using published data we demonstrate that a slight, but realistic, change in how the sample size is calculated results in an increase in the sample size of nearly 300%.