LEADERSHIP TEAM ARTICLES
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Webinar: Non-Inferiority trial designs to establish effectiveness, when to use it? What is the Margin, how to set it, and its impact on sample size/power?
Presented by: Dr. Kazem Kazempour
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 discussed when and why an Non-Inferiority trial is needed, how to design and interpret the results of a NI study so that it can be used as an FDA acceptable, adequate and well-controlled trial to establish effectiveness. Lastly, we discussed the margins used in these types of studies and their impact on the size and power of the study.