What is a non-inferiority analysis?

What is a non-inferiority analysis?

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 is non-inferiority criteria?

Non-inferiority studies are appearing in medical journals with increasing frequency. The non-inferiority margin describes the amount of reduction in efficacy that will be tolerated. As long as the new treatment is not worse than the standard treatment by this margin, the new treatment would be considered non-inferior.

What does a non inferiority trial really mean?

As clinicians, we are frequently faced with papers stating that something is ‘non-inferior’ to something else. 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 does’non-inferior to’really 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- … As clinicians, we are frequently faced with papers stating that something is ‘non-inferior’ to something else.

What’s the difference between an equivalence and a noninferiority trial?

Although noninferiority and equivalence trials have often been both referred to as “equivalence trials,” they are distinct. 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.

How to analyze data from a noninferiority trial?

Analysis of noninferiority trials A naïve approach to analyzing experimental data from active control trials is to compare new and control treatments in the standard way and, if no difference is detected, to declare the treatments equivalent.