手法を比較

	等価性／非劣性試験	逐次 / 群逐次試験デザイン
分野	実験計画法	実験計画法
系統	Hypothesis test	Hypothesis test
提唱年	1987	1979
提唱者	Schuirmann, D.J. / EMA regulatory framework	O'Brien & Fleming; Pocock; Lan & DeMets
種類	Parametric equivalence / non-inferiority test	Adaptive stopping trial design
原典	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.
別名	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)
関連	6	3
概要	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.