Сравнение на методи

	Изпитване за еквивалентност / не-по-лошост	Последователен / Групов последователен дизайн на изпитвания
Област	Планиране на експеримента	Планиране на експеримента
Семейство	Hypothesis test	Hypothesis test
Година на възникване	1987	1979
Създател	Schuirmann, D.J. / EMA regulatory framework	O'Brien & Fleming; Pocock; Lan & DeMets
Тип	Parametric equivalence / non-inferiority test	Adaptive stopping trial design
Основополагащ източник	Schuirmann, D.J. (1987). A Comparison of the Two One-Sided Tests Procedure and the Power Approach. Journal of Pharmacokinetics and Biopharmaceutics, 15(6), 657–680.	O'Brien, P.C. & Fleming, T.R. (1979). A Multiple Testing Procedure for Clinical Trials. Biometrics, 35(3), 549–556.
Други названия	non-inferiority trial, bioequivalence study, active-control trial, Denklik ve Üstünlük Olmayan Çalışma (Equivalence / Non-Inferiority)	group sequential design, adaptive stopping design, Ardışık Deneme Tasarımı (Sequential / Group Sequential)
Свързани	6	3
Резюме	An equivalence or non-inferiority trial is a clinical study design that tests whether a new intervention is clinically equivalent to, or no worse than, an established standard by a pre-specified margin. Codified in Schuirmann's 1987 Two One-Sided Tests (TOST) framework and embedded in EMA and FDA regulatory guidance, this design is the regulatory standard for generic drug approval and medical device testing.	Sequential and group sequential trial designs allow a study to be stopped early — or continued — based on interim analyses conducted as data accumulate. The core framework was formalised by O'Brien and Fleming in 1979 and extended by Lan and DeMets's alpha-spending approach, and it controls the overall Type I error rate across all planned looks by pre-specifying both efficacy and futility boundaries before enrolment begins.