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.
But let's first review what an active control trial is.
It's a trial in which an experimental intervention is
compared with an accepted standard intervention which we call the active control.
These trials have the objective to show efficacy of the test treatment by showing one,
it is superior to the active control,
or your question might be it is as good as the active control,
or it is not inferior to the active control.
All of these are active controlled trials because of
the comparator arm, meaning the active control.
However, you might have different questions and depending on your question,
we'll tell you which design you're actually choosing for your study.