A study that tests whether a new treatment is not worse than an active treatment it is being compared to
. Non-inferiority trials are sometimes done when a placebo (an inactive treatment) cannot be used.
How do you determine non-inferiority?
In order to demonstrate non-inferiority, the recommended approach is
to pre-specify a margin of non- inferiority in the protocol
. After study completion, a two-sided 95% confidence interval (or one-sided 97.5% interval) for the true difference between the two agents will be constructed.
What is the difference between a non-inferiority trial and a superiority trial?
In comparison studies with a current therapy, non-inferiority is used to demonstrate that the
new therapy provides at least the same benefit to the patient
. Superiority trials are always used when comparisons are made to placebo or vehicle treatments.
What is non-inferiority criteria?
Active control trials aim to demonstrate that treatments of interest have either superior effects or similar effects to the control. … If the intent of a study is to demonstrate that
an experimental treatment is not substantially worse than a control treatment
, the study is known as a noninferiority trial.
What does non-inferiority margin mean?
By definition, a non-inferiority trial aims
to demonstrate that the test product is not worse than the comparator by more than a small pre-specified amount
. This amount is known as the non-inferiority margin, or delta.
Can you claim superiority in a non-inferiority trial?
In a non-inferiority trial, the focus is on the lower bound margin, what happens at the upper end is not of primary concern in this type of trial design. One can also declare superiority in a non-inferiority trial
if the lower limit of CI of the new treatment is above the non-inferiority margin and above zero
.
What is the null hypothesis in a non-inferiority trial?
The null hypothesis in non-inferiority trials is
that new treatment is inferior to standard treatment
. The alternative hypothesis is the new treatment is non-inferior to standard treatment.
What is the purpose of a non-inferiority trial?
A study that tests whether a new treatment is not worse than an active treatment it is being compared to
. Non-inferiority trials are sometimes done when a placebo (an inactive treatment) cannot be used.
What is a non-inferiority limit?
By definition, a non-inferiority trial aims to demonstrate that
the test product is not worse than the comparator by more than a small pre-specified amount
. This amount is known as the non-inferiority margin, or delta. Clinicians must know who has chosen the margin, and why.
What is inferiority margin?
Abstract. Noninferiority trials are
used to assess whether the effect of a new drug is not worse than an active comparator by more than
a noninferiority margin. If the difference between the new drug and the active comparator does not exceed this prespecified margin, noninferiority can be concluded.
What phase is a non-inferiority trial?
Non-inferiority (NI) trials in drug research are used to demonstrate that a new treatment is not less effective than an active comparator. Since
phase IV trials
typically aim at informing a clinical decision, the value of a phase IV non-inferiority trial hinges also on its clinical relevance.
What is a pragmatic trial design?
Pragmatic trials are
designed to evaluate the effectiveness of interventions in real-life routine practice conditions
, whereas explanatory trials aim to test whether an intervention works under optimal situations. Pragmatic trials produce results that can be generalized and applied in routine practice settings.
What is the null hypothesis for superiority trial?
The null hypothesis (H
0
) of superiority trials
asserts that there is no true difference between the interventions
, and the alternative hypothesis (H
1
) states that there is a difference between the interventions. A type I error is the error of rejecting H
0
when it is actually true.
What is a superiority margin?
There is a percentage
above 70% at
which the difference between the two treatments is no longer considered ignorable. … The difference between these two percentages is called the margin of superiority.
What is intention to treat vs per protocol?
Intention-to-treat analysis is
a comparison of the treatment groups that includes all patients as originally allocated after randomization
. … Per-protocol analysis is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated.
What is a non superiority trial?
Unlike superiority trials that are designed to show that one treatment is better than another, a non-inferiority trial is
designed to show that a new treatment is ‘not unacceptably worse’ than the current standard therapy
.
