Evaluating superiority, 'equivalence and non-inferiority in clinical trials
Küçük Resim Yok
Tarih
2007
Yazarlar
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
K Faisal Spec Hosp Res Centre
Erişim Hakkı
info:eu-repo/semantics/closedAccess
Özet
Clinical 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.
Açıklama
Anahtar Kelimeler
Placebo-Controlled Trials, Active-Control Trials
Kaynak
Annals Of Saudi Medicine
WoS Q Değeri
Q4
Scopus Q Değeri
Cilt
27
Sayı
4
