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 do you prove non-inferiority?
Traditional statistical methods were designed to demonstrate differences and cannot easily show that a new treatment is similar to an older one. Non-inferiority can be shown if the difference between two treatments does not cross a predefined inferiority margin.
What is the null hypothesis in a superiority trial?
The null hypothesis (H0) of superiority trials asserts that there is no true difference between the interventions, and the alternative hypothesis (H1) states that there is a difference between the interventions. A type I error is the error of rejecting H0 when it is actually true.
What is a non-inferiority trial?
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.
Can you test for superiority in a non-inferiority trial?
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. This is acceptable because it usually takes into account and controls for the Type 1 error and does not penalize for multiple testing.
Is non-inferiority the same as equivalence?
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.
When can non-inferiority trial be used?
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. However, there are some complicated issues with trials of this type that make them less reliable than typical superiority trials6-9).
Can a non-inferiority trial show superiority?
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.
Can you prove superiority in a non-inferiority trial?
How do you interpret non-inferiority trial results?
The calculated CI does not know whether its purpose is to judge superiority or non-inferiority. If it sits wholly above zero, then it has shown superiority. If it sits wholly above -Δ, then it has shown non-inferiority. A non-inferiority trial can have five possible types of outcomes as depicted in Figure 2.
How can you differentiate between superiority and non-inferiority clinical 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 the main difference between non-inferiority and equivalence trials conceptually and statistically?
Why do a non-inferiority trial?
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 does testing for non-inferiority test for equivalence?
Non-inferiority is shown if the lower side of a two-sided (1–2α)×100% CI is above -Δ. In this case that means a 95 % CI, so the significance level is 0.025. Using the two one-sided test (TOST) procedure, equivalence is tested using a (1–2α)×100% CI. In this case this significance level is also 0.025.