The limitations of equivalence and non-inferiority trials

Equivalence and non-inferiority trials are becoming more and more popular. Typically, they compare the effects of a treatment of interest with the current gold-standard treatment as the comparator. However, for this approach, the definition of equivalence or non-inferiority margins (NIM) is crucial, and no clear rules for their definition exist. We criticized the practice of these trials of being over-inflationary in favor of (erroneous)...