What is a non-inferiority study?

What is a non-inferiority study?

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?

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 noninferior mean?

(non″in-fēr′ē-ŏr) [ non- + inferior] In a clinical trial, jargon for at least as good as.

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.

How are non-inferiority margins determined?

If the difference between the new drug and the active comparator does not exceed this prespecified margin, noninferiority can be concluded. This margin must be specified based on clinical and statistical reasoning; however, it is considered as one of the most challenging steps in the design of noninferiority trials.

How do you read a non-inferiority margin?

The calculated CI does not know whether its purpose is to judge superiority or non-inferiority. If it sits wholly above zero, then it has shown superiority. If it sits wholly above -Δ, then it has shown non-inferiority. A non-inferiority trial can have five possible types of outcomes as depicted in Figure 2.

What is the main difference between non-inferiority and equivalence trials conceptually and statistically?

Trials which compare treatments may not be designed to show that one treatment is superior. These are known as non-inferiority or equivalence trials. Non-inferiority trials aim to show that the new drug is no worse than standard treatment. Equivalence trials aim to show the new treatment is no better and no worse.

How is non-inferiority margin determined?

The margin represents the remaining fraction of M1, which is called M2. For example, if it is decided that 75% of M1 must be preserved by the new drug to demonstrate noninferiority, M2 = (1 – 0.75) × M1 = 0.25 × M1 (or 25% of M1) 2, 3.

What is non-inferiority design?

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.