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Superiority, equivalence, and non-inferiority trials.

Authors: Lesaffre, Emmanuel;

Superiority, equivalence, and non-inferiority trials.

Abstract

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. Proving that two treatments are equal in performance is impossible with statistical tools; at most, one can show that they are equivalent. 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. In this report, the three types of trials are compared, but the main focus is on the non-inferiority trial. Special attention is paid to the practical implications when setting up a non-inferiority trial. Illustrations are taken from a clinical trial in osteoarthritis and from thrombolytic research.

Country
Netherlands
Related Organizations
Keywords

Sulfonamides, Pyridines, EMC NIHES-01-66-01, Statistics as Topic, Myocardial Infarction, Osteoarthritis, Knee, Osteoarthritis, Hip, Etoricoxib, Treatment Outcome, Celecoxib, Humans, Pyrazoles, Cyclooxygenase Inhibitors, Thrombolytic Therapy, Sulfones, Pain Measurement, Randomized Controlled Trials as Topic

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Powered by OpenAIRE graph
Found an issue? Give us feedback
selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
139
Top 1%
Top 1%
Top 10%
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