Can you show superiority in 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 is the difference between a non-inferiority trial and a superiority trial?
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.
Why is non-inferiority more challenging than superiority?
Non-inferiority trials are generally large because of their need to exclude the possibility of a small degree of inferiority of a new agent relative to an active control. However if the new agent is actually superior to control by a small amount, then the power to show its non- inferiority is increased.
What is a Phase 3 superiority trial?
Most phase III trials aim to demonstrate the superiority of a new treatment in comparison with control; however, phase III trials may also assess whether a more convenient, less toxic, or more affordable intervention is at least as efficacious as an existing standard of care, and these are called non-inferiority trials …
Are superiority trials two-sided?
For superiority trials, there are two things to consider: #1 Active arm is compared to placebo for superiority. In this situation it makes sense to use a one-sided test at a statistical significance level of 2.5%. In this situation it makes sense to use a two-sided test at a statistical significance level of 0.05.
What is an acceptable noninferiority margin?
In order to demonstrate non-inferiority, the recommended approach is to pre-specify a margin of non- inferiority in the protocol. After study completion, a two-sided 95% confidence interval (or one-sided 97.5% interval) for the true difference between the two agents will be constructed.
Are superiority trials two sided?
What is non-inferiority analysis?
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.
How do you analyze non-inferiority?
Statistical analysis. A non-inferiority trial should specify whether a one- or two-sided CI is placed around the estimate of difference between treatments. If a two-sided test is used, the 95% CI applies; if a one-sided test is used, the 97.5% CI applies. Use of more liberal 90% CIs should be viewed with caution.
What is the null hypothesis in a non-inferiority trial?
The null hypothesis in non-inferiority trials is that new treatment is inferior to standard treatment. The alternative hypothesis is the new treatment is non-inferior to standard treatment.
What is a non-inferiority trial?
Is superiority complex a mental disorder?
Today, there is no official mental health diagnosis called a “superiority complex”. However, this idea can still describe why some people exaggerate their accomplishments and successes.