In November 2016, FDA finalized the guideline for Non-Inferiority (NI) trial design to establish effectiveness.
The draft of this guideline and several similar guidelines were published in 2010, and in most part were in use prior to being finalized. The new guidance has replaced the drafted guidance(s) for industry.
In this talk, we discuss when and why an NI trial is needed, how to design and interpret the results of a Non-Inferiority study so that it can be used as an FDA acceptable, adequate and well-controlled trial to establish effectiveness. Lastly, we will discuss the Margins used in these types of studies and their impact on the size and power of the study.