Active control trials aim to demonstrate that treatments of interest have either superior effects or similar effects to the control. ... If the intent of a study is to demonstrate that an experimental treatment is not substantially worse than a control treatment , the study is known as a noninferiority trial.
What is the difference between a non-inferiority trial and a superiority trial?
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.
What is meant by 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 the difference between non-inferiority and equivalence trials?
In an equivalence trial, the statistical test aims at showing that two treatments are not too different in characteristics, where “not too different” is defined in a clinical manner. Finally, in a non-inferiority trial, the aim is to show that an experimental treatment is not (much) worse than a standard treatment.
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 null hypothesis in 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.
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 .
What is the null hypothesis for superiority trial?
The null hypothesis (H 0 ) of superiority trials asserts that there is no true difference between the interventions , and the alternative hypothesis (H 1 ) states that there is a difference between the interventions. A type I error is the error of rejecting H 0 when it is actually true.
What phase is a non-inferiority trial?
Non-inferiority (NI) trials in drug research are used to demonstrate that a new treatment is not less effective than an active comparator. Since phase IV trials typically aim at informing a clinical decision, the value of a phase IV non-inferiority trial hinges also on its clinical relevance.
What is a non superiority trial?
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 calculate sample size for non-inferiority trials?
The sample size required for a non-inferiority clinical trial can be calculated using the formula in Figure 1 [5] ,[6]. Table 4 gives common Normal deviates for different percentiles. For example, for β = 0.1, we would have x = 0.1 and Z1-x = 1.282, while for α = 0.05, we would have x = 0.025 and Z1-x = 1.96.
Is non inferior the same as equivalent?
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 does non inferior mean?
Abstract. As clinicians, we are frequently faced with papers stating that something is ‘non-inferior’ to something else. 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.
What is a non-inferiority limit?
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 inferiority margin?
Abstract. 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.
What is a superiority margin?
There is a percentage above 70% at which the difference between the two treatments is no longer considered ignorable. ... The difference between these two percentages is called the margin of superiority.
