How do you determine 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 interpret a non-inferiority trial?
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 test for non-inferiority?
For example, if we are testing for noninferiority with a 5% significance level, we would construct a 90% 2-sided confidence interval and use the lower bound to determine noninferiority.
Two-sided confidence intervals are usually useful in equivalence testing, where one is interested in the composite hypothesis (3)..
What is a non-inferiority study design?
Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin..
What is a randomized noninferiority trial?
Although it is not statistically possible to prove that two treatments are identical, it is possible to determine that a new treatment is not worse than the control treatment by an acceptably small amount, with a given degree of confidence.
This is the premise of a randomized, noninferiority trial..
What is non inferiority in research?
Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin..
What is the hypothesis for a non-inferiority trial?
In a noninferiority trial, the null hypothesis states that the primary end point for the new treatment is worse than that of the active control by a prespeci- fied margin, and rejection of the null hypothesis at a prespecified level of statistical significance permits a conclusion of noninferiority..
What is the hypothesis testing for non-inferiority?
Hypothesis testing in non-inferiority trials
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 hypothesis testing in a non-inferiority trial?
Hypothesis testing in non-inferiority trials
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..
- Although it is not statistically possible to prove that two treatments are identical, it is possible to determine that a new treatment is not worse than the control treatment by an acceptably small amount, with a given degree of confidence.
This is the premise of a randomized, noninferiority trial. - If a new treatment is shown to be non-inferior to standard treatment, all it means is that the new treatment is not worse than the standard treatment by the predetermined non-inferior margin.
The new treatment may subsequently replace the old standard treatment and be accepted as the new standard treatment. - In addition, the sample size of a noninferiority trial is very sensitive to the assumed effect of the new treatment relative to the active control; the sample size can be considerably larger if the two treatments are assumed to be equivalent than if the new treatment is assumed to be slightly more effective than the
