What is a superiority clinical trial?
A superiority trial is designed to detect a difference between treatments. The first step of the analysis is usually a test of statistical significance to evaluate whether the results of the trial are consistent with the assumption of there being no difference in the clinical effect of the two treatments.
What is the difference between non-inferiority and equivalence trials?
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. This is the definition of what would be the minimum important difference between the treatments.
Why is non-inferiority more challenging than superiority?
Non-inferiority trials are generally large because of their need to exclude the possibility of a small degree of inferiority of a new agent relative to an active control. However if the new agent is actually superior to control by a small amount, then the power to show its non- inferiority is increased.
Are superiority trials two-sided?
For superiority trials, there are two things to consider: #1 Active arm is compared to placebo for superiority. In this situation it makes sense to use a one-sided test at a statistical significance level of 2.5%. In this situation it makes sense to use a two-sided test at a statistical significance level of 0.05.
What is superiority and inferiority?
inferiority complex. A superiority complex is an exaggerated sense of self-worth. It hides real feelings of mediocrity. An inferiority complex is an overstated feeling of weakness. It often hides true motives, such as aspirations for power.
What does a non-inferiority trial mean?
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 non-inferiority trial?
What is a Phase 3 superiority trial?
Most phase III trials aim to demonstrate the superiority of a new treatment in comparison with control; however, phase III trials may also assess whether a more convenient, less toxic, or more affordable intervention is at least as efficacious as an existing standard of care, and these are called non-inferiority trials …
Can I have both superiority and inferiority complex?
Ada Kahn has argued that the superiority and inferiority complexes cannot both be found in the same individual, since an individual with a superiority complex truly believes that they are superior to others.
What is the difference between a god complex and superiority complex?
A person with a superiority complex believes that they are exceptionally better than others. They have a sense of exaggerated self-esteem and believe that whatever they do, say or believe is right. God complex: People with a God complex think that they have divine, God-like powers and are above all mankind.
Is there such a thing as a non inferiority trial?
The European Medicines Agency states the “ pre-definition of a trial as a superiority trial, an equivalence trial or a non-inferiority trial is necessary for numerous reasons ” [ 4 ], and one reporting guideline asserts that non-inferiority trials present “particular difficulties in their design, analysis, and interpretation ” [ 2 ].
Is there a rationale for superiority and non-inferiority?
Main text: There is a clear rationale for the superiority/non-inferiority framework in the context of regulatory trials. The focus of our article is non-regulatory trials with a public health objective.
When do you use superiority in a trial?
Superiority trials are always used when comparisons are made to placebo or vehicle treatments. In these studies, it is critical that the effect in the treatment group be clearly superior to any effects in the placebo groups. Failure to demonstrate superiority over vehicle suggests that the drug is not effective.
Can a nonsignificant superiority test show that?
Often a nonsignificant superiority test is wrongly interpreted as proof of no difference between the two treatments. Proving that two treatments are equal in performance is impossible with statistical tools; at most, one can show that they are equivalent.