What is non-inferiority trial design?
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 a non-inferiority design?
In a trial intending to show that there is a difference less than a specific amount between control and experimental treatments, a noninferiority design statistically tests the null hypothesis that the experimental treatment is inferior by the equivalence margin.
What is non-inferiority margin in clinical trials?
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 non-inferiority and superiority clinical trials?
Introduction. Unlike superiority trials that are designed to show that one treatment is better than another, a non-inferiority trial is designed to show that a new treatment is ‘not unacceptably worse’ than the current standard therapy.
How do you determine non-inferiority?
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.
What is the meaning of non-inferiority?
What is meant by non-inferiority?
What phase is a non-inferiority trial?
A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar standard superiority trial. Because of the large required sample size, we often face feasibility issues to open a non-inferiority trial.
How do you evaluate a non-inferiority trial?
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.
How do you analyze non-inferiority?
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.
How do you calculate non-inferiority?
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.
What is the main advantage of non-inferiority trials when testing a new drug?
Non-inferiority clinical trials are being performed with an increasing frequency now-a-days, because it helps in finding a new treatment that have approximately the same efficacy, but may offer other benefits such as better safety profile.
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 the difference between non-inferiority trials and typical clinical trial designs?
We will explain the difference between non-inferiority trials and more typical clinical trial designs to help build understanding of the non-inferiority limit. Standard clinical trials usually aim to show that a new treatment is better than an existing one.
What is the non-inferiority margin used in the non inferiority study?
Choice of the Non-Inferiority Margin. M or Δ is the non-inferiority margin used in the non-inferiority study. This non-inferiority margin is selected prior to the trial. Non-inferiority margin is the degree of inferiority of the test treatments to the control and the trial will attempt to exclude it statistically.
Can you switch between superiority and noninferiority in clinical trials?
Switching between superiority and noninferiority Interpreting a noninferiority trial as a superiority trial is credible and without a need for a statistical penalty for multiple testing.
What is a noninferiority design?
In a trial intending to show that there is a difference less than a specific amount between control and experimental treatments, a noninferiority design statistically tests the null hypothesis that the experimental treatment is inferior by the equivalence margin.