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How do you test for superiority?
Superiority tests are one-sided hypothesis tests in which the null and alternative hypotheses are arranged to test whether one group is better than the other group by more than a stated margin. So, we might be interested in showing that a new method of treatment is better by more than a clinically insignificant amount.
What is a Phase 3 superiority trial?
Most phase III trials in oncology aim to demonstrate the superiority of a new treatment in comparison with control, but so-called non-inferiority phase III trials assess whether a more convenient, less toxic, or more affordable intervention is at least as efficacious as an existing standard of care.
What is superiority clinical trials?
When the aim of the randomized controlled trial (RCT) is to show that one treatment is superior to another, a statistical test is employed and the trial (test) is called a superiority trial (test). Often a nonsignificant superiority test is wrongly interpreted as proof of no difference between the two treatments.
What is meant by inferiority vs superiority?
The superiority comparison is a subset of the non-inferiority and will have a sample size that is similar to the non-inferiority or a sample size that is much larger. As the expected difference between the two treatments decreases, the sample size will increase, often dramatically.
What is an inferiority study?
In a trial intending to show that there is a difference less than a specific amount between control and experimental treatments, a noninferiority design statistically tests the null hypothesis that the experimental treatment is inferior by the equivalence margin.
What does noninferior mean?
(non″in-fēr′ē-ŏr) [ non- + inferior] In a clinical trial, jargon for at least as good as.
What is the purpose of a superiority trial?
A superiority trial aims to demonstrate the superiority of a new therapy compared to an established therapy or placebo. The following description applies to a superiority trial. The features, by which an equivalence or a non-inferiority trial differ, will be described later.
When do you use superiority test in a RCT?
When the aim of the randomized controlled trial (RCT) is to show that one treatment is superior to another, a statistical test is employed and the trial (test) is called a superiority trial (test). Often a nonsignificant superiority test is wrongly interpreted as proof of no difference between the two treatments.
How are superiority trials different from non-equivalence trials?
The awareness of the methodological differences is generally quite limited. For example it is a rather common belief that failure of finding a significant difference between therapies in a superiority trial implies that the therapies have the same effect or are equivalent [5], [6], [7], [8], [9], [10].
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.