How do you determine non-inferiority?
The outcome of a non-inferiority trial is usually assessed by a two-sided 95% confidence interval, showing a credible range for the true difference between the test product (test: T) and the active comparator (reference: R). There are two aspects of the results that should attract particular attention.
What is the 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.
What is non-inferiority?
What is non-inferiority hypothesis?
The null hypothesis in non-inferiority trials is that new treatment is inferior to standard treatment. If the results of the trial are statistically significant, the null hypothesis can be rejected and the alternative hypothesis that the new treatment is non-inferior to standard treatment can be accepted.
What is a non-inferiority comparison?
In a trial intending to show that there is a difference less than a specific amount between control and experimental treatments, a noninferiority design statistically tests the null hypothesis that the experimental treatment is inferior by the equivalence margin.
What is non-inferiority and superiority clinical trials?
A superiority trial is designed to show that a new treatment is better than an active control or placebo. A non-inferiority trial is different as it is designed not to show that treatments are equal, or ‘not different’, but that the new treatment is not unacceptably worse than, or ‘non-inferior’ to, an active control.
What are superiority and non-inferiority trials?
How is a noninferiority design used in a trial?
In a trial intending to show that there is a difference less than a specific amount between control and experimental treatments, a noninferiority design statistically tests the null hypothesis that the experimental treatment is inferior by the equivalence margin.
Why are noninferiority trials more complex than superiority trials?
Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.
How are noninferiority margins determined in a clinical trial?
Choice of the noninferiority margin is critical in designing noninferiority trials. One reasonable way to define a margin is to base it on some proportional effect that the active control has shown over placebo in previous studies. However, the margin should be based on both statistical reasoning and clinical judgment.
Which is the best method for noninferiority analysis?
There are several factors and assumptions that need to be accounted for during the process of defining the margin and during the analysis of noninferiority. Three methods are commonly used to analyse noninferiority trials: the fixed‐margin method; the point‐estimate method; and the synthesis method.