Evaluating "superiority", "equivalence" and "non-inferiority" in clinical trials

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dc.authorscopusid8560325700
dc.authorscopusid7005232620
dc.contributor.authorTuran F.N.
dc.contributor.authorŞenocak M.
dc.date.accessioned2024-06-12T10:26:25Z
dc.date.available2024-06-12T10:26:25Z
dc.date.issued2007
dc.description.abstractClinical studies are usually performed with the aim of justifying that a new treatment approach is "superior" to the common standard approach (active control) with respect to benefits. In a general sense, this justification is carried out on the basis of the "null hypothesis significance test" with the P value based on this test used for justification. Today, new drugs differ so little from existing ones that factors such as cost and side effects affect the choice of therapy, when the bioavailability of treatment methods are found equivalent.Therefore, the aim of comparative clinical trials has extended beyond showing that a treatment is "superior" and now attempts to show that new treatments are "equal" and "non-inferior" to existing treatments. New approaches have become necessary since the classical null hypothesis approach is insufficient to justify the use of new agents, especially in cases of "equivalence" and "non-inferiority". This new approach to justification makes use of the "clinical equivalence interval", which determines the limits of the differences between specific endpoints that can be regarded as clinically "equal" to the value that was pre-specified based on studies of established therapies. It also makes use of the quantitative-based "confidence intervals" as the criteria for statistical justification. Many analyses can be done confidently when these tools are applied and the data are interpreted correctly.en_US
dc.identifier.doi10.5144/0256-4947.2007.284
dc.identifier.endpage288en_US
dc.identifier.issn0256-4947
dc.identifier.issue4en_US
dc.identifier.pmid17684429en_US
dc.identifier.scopus2-s2.0-34948876462en_US
dc.identifier.scopusqualityQ3en_US
dc.identifier.startpage284en_US
dc.identifier.urihttps://doi.org/10.5144/0256-4947.2007.284
dc.identifier.urihttps://hdl.handle.net/20.500.14551/16842
dc.identifier.volume27en_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherKing Faisal Specialist Hospital and Research Centreen_US
dc.relation.ispartofAnnals of Saudi Medicineen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectNew Drug; Bioavailability; Bioequivalence; Clinical Research; Clinical Study; Clinical Trial; Confidence Interval; Data Analysis; Drug Cost; Human; Methodology; Null Hypothesis; Priority Journal; Quantitative Study; Review; Statistical Significance; Unspecified Side Effecten_US
dc.titleEvaluating "superiority", "equivalence" and "non-inferiority" in clinical trialsen_US
dc.typeReview Articleen_US

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