手法を比較

	等価性／非劣性試験	逐次分析（群逐次計画）
分野	実験計画法	統計学
系統	Hypothesis test	Hypothesis test
提唱年	1987	1977
提唱者	Schuirmann, D.J. / EMA regulatory framework	P. C. O'Brien & T. R. Fleming; P. C. Pocock
種類	Parametric equivalence / non-inferiority test	Sequential / adaptive hypothesis test
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)	sequential testing, group sequential design, interim analysis, Sıralı Analiz (Sequential Testing / Group Sequential Design)
関連	6	5
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 analysis is a framework for conducting hypothesis tests with pre-planned interim looks at accumulating data, allowing a study to stop early for efficacy or futility while controlling the overall Type I error rate. The group sequential approach was formalised by Pocock (1977) and O'Brien and Fleming (1979), and remains the standard for confirmatory clinical trials and rigorous A/B experiments.