How do you test for non-inferiority?

How do you test for non-inferiority?

In noninferiority testing, a common practice is to set the value of δ to a fraction, f, of the lower limit of a confidence interval of the difference between the current therapy and the placebo obtained from a meta-analysis.

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 phase is a non-inferiority trial?

phase IV
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 an appropriate non-inferiority margin?

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 a non-inferiority p value?

In non-inferiority trials, investigators are interested in whether new treatment is non-inferior to standard treatment. Only the non-inferior margin to the right side of unity on the forest plot is specified. Therefore, the significance level is usually set as a one-sided p value of 0.025.

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.

How is non-inferiority determined in a meta-analysis?

Procedure of non-inferiority assessment using meta-analysis. For each cancer location and clinical endpoint, the objectives margins were calculated in order to preserve at least 50% of the reported effect of conventionally fractionated RT.

How to assess the non-inferiority of a treatment?

To assess the non-inferiority of an experimental treatment versus an active comparator two quantities are needed: i) the value of the non-inferiority margin and ii) an estimation of experimental treatment’s effect versus the active comparator. The procedure proposed in this work is divided in three steps:

How are noninferiority trials used in medical research?

Abstract Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use.

When is a noninferiority trial called a superiority trial?

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. However, there are some complicated issues with trials of this type that make them less reliable than typical superiority trials6-9).