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.

How do you calculate non-inferiority sample size?

To calculate the sample size, we can use Table 5, which gives calculated sample sizes for various standardised non-inferiority limits (δNI = dNI/σ). The percentage mean differences are given for the case where it is anticipated that there may be a non-zero difference between treatments, that is, µA−µB = 0.

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.

Can you determine superiority from 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 does noninferior mean?

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

What’s 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 non-inferiority?

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

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. An equivalence boundary should be set before the trial. This is the definition of what would be the minimum important difference between the treatments.

What are non-inferiority statistics?

Non-inferiority can be shown if the difference between two treatments does not cross a predefined inferiority margin. • Non-inferiority studies need to be carefully planned; failings in the design of the study may make accepting an inferior treatment more likely.

What is non-inferiority testing?

What is non-inferiority analysis?

in-FEER-ee-OR-ih-tee TRY-ul) 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 non-inferiority in statistics?

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 the p value for non inferiority?

However, the P value that is calculated in NITs is special and is called the P value for non-inferiority, which differs from the P value for superiority [3]. The finding that P value of the difference in mortality was 0.033 means only that H1 is accepted and the lactate strategy is not inferior to the ScvO2 strategy.

Which is the best definition of a non inferiority test?

Non-Inferiority Tests. Non-inferiority tests are one-sided hypothesis tests in which the null and alternative hypotheses are arranged to test whether one group is almost as good (not much worse) than the other group.

What is the p value for noninferiority RCTs?

Adoption of the H 0 or H 1 “answer” as true involves a decision rule based on the statistical significance of the P value. However, the P value that is calculated in noninferiority RCTs is special, and is called the P value for noninferiority.

How is the noninferiority of a trial determined?

The noninferiority margin is determined by halving the control effect, based on a historical placebo-controlled trial. The upper limit of the 95% confidence interval (CI) for the treatment difference by the new treatment compared to the control is less than the margin to conclude noninferiority, although there is an implication of incomparability.