Non-inferiority Trials: Practical Issues and Current Regulatory Perspectives

Why Should You Attend:

Basic non-inferiority (NI) clinical study designs appear to provide a straight-forward approach for evaluating whether a new drug or medical device is an appropriate substitute or replacement for a current standard treatment. In these studies the typical comparison is between a new drug and an active control with the goal of demonstrating that the new drug is “not inferior” to the standard treatment by “too large” a margin. Traditional approaches to demonstrating NI of a new drug amounted to a simple acceptance of the null hypothesis of no difference between that drug and an active control, but these are currently recognized as inadequate to support a claim of NI.

This webinar will examine the philosophy and assumptions underlying NI trials by highlighting the differences among NI, equivalence, and superiority trials with regard to basic clinical study designs and appropriate hypothesis tests, power and sample size, and conceptual and statistical analysis differences. We will conclude with a review of current FDA guidance for NI clinical studies.

Areas Covered in the Seminar:

• Description and comparison of NI, equivalence, and superiority study objectives and designs.
• Zeroing in on the specific clinical question to be asked.
• Decision tree for choosing the appropriate design to answer the specific clinical question.
• Why assay sensitivity matters and what you can do to maximize it.
• How to determine the appropriate or acceptable “margin” of inferiority.
• Appropriate hypothesis tests and statistical interpretation. (for non-statisticians).
• FDA guidance.