Greetings everyone. My name is Valerie Durkalski-Mauldin,
I'm a professor of Biostatistics in
the Department of Public Health Sciences at the Medical University of South Carolina.
Today I'll be speaking with you about the design and conduct of non-inferiority trials.
The objectives of today's talk are to review
when non-inferiority is the correct question for your trial,
how to choose the margin of non-inferiority,
what is the importance of maintaining
trial validity when conducting a non-inferiority trial,
and how do you interpret the results.
The outline of my presentation will first begin
with the actual definition of a non-inferiority trial,
we'll talk about key trial design issues such as
the choice of the active control and the choice of the margin,
we'll review analysis approaches as well as key points to consider.
So, when we talk about non-inferiority trials,
there's other terminology or jargon that comes into play.
Some might say, an active control trial or
an equivalence trial or a bio-equivalence trial,
and these are all legitimate terms
but they really are talking about different types of studies.
Today, we're going to be focusing on when we're concerned about a one-sided questions.
So, it'll be the non-inferiority trial setting.