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

Basit Öğe Kaydı
dc.contributor.authorTuran, Fatma Nesrin
dc.contributor.authorSenocak, Mustafa
dc.date.accessioned2024-06-12T11:19:36Z
dc.date.available2024-06-12T11:19:36Z
dc.date.issued2007
dc.departmentTrakya Üniversitesien_US
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.endpage288en_US
dc.identifier.issn0256-4947
dc.identifier.issn1319-9226
dc.identifier.issue4en_US
dc.identifier.pmid17684429en_US
dc.identifier.startpage284en_US
dc.identifier.urihttps://hdl.handle.net/20.500.14551/25271
dc.identifier.volume27en_US
dc.identifier.wosWOS:000249469400008en_US
dc.identifier.wosqualityQ4en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherK Faisal Spec Hosp Res Centreen_US
dc.relation.ispartofAnnals Of Saudi Medicineen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectPlacebo-Controlled Trialsen_US
dc.subjectActive-Control Trialsen_US
dc.titleEvaluating superiority, 'equivalence and non-inferiority in clinical trialsen_US
dc.typeReview Articleen_US

Dosyalar

Koleksiyon

WoS İndeksli Yayınlar Koleksiyonu
PubMed İndeksli Yayınlar Koleksiyonu