What is an acceptable non-inferiority 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.
How is non-inferiority margin decided?
If the difference between the new drug and the active comparator does not exceed this prespecified margin, noninferiority can be concluded. This margin must be specified based on clinical and statistical reasoning; however, it is considered as one of the most challenging steps in the design of noninferiority trials.
Can you claim 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.
How do you prove non-inferiority?
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 meant by non-inferiority?
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.
What is the null hypothesis for 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.
How is NI margin calculated?
The net profit margin is calculated by taking the ratio of net income to revenue. Net profit margin is calculated as follows: $4,350 / $6,400 = . 68 x 100 = 68%
What is non-inferiority design?
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 are superiority and non-inferiority trials?
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.
What is non-inferiority and superiority clinical trials?
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.
Why do a non-inferiority study?
Why noninferiority trials? Noninferiority trials may be performed to demonstrate that a new treatment is better than an assumed placebo in situations where conducting a placebo control trial is unethical.
How do you calculate sample size for non-inferiority trials?
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.