Non-inferiority Trials: Practical Issues and Current Regulatory Perspectives November 1, 2012

This webinar will examine and highlight differences among non-inferiority (NI) trials, equivalence, and superiority study objectives and designs. It will also review current FDA guidance for NI clinical studies.

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.

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