השוואת שיטות

	ניסוי שקילות / אי-נחיתות	תכנון ניסויים קליניים אדפטיביים
תחום	תכנון ניסויים	תכנון ניסויים
משפחה	Hypothesis test	Hypothesis test
שנת המקור	1987	1994
הוגה השיטה	Schuirmann, D.J. / EMA regulatory framework	Bauer & Köhne
סוג	Parametric equivalence / non-inferiority test	Adaptive hypothesis test with interim analyses
מקור מכונן	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.	Bauer, P. & Köhne, K. (1994). Evaluation of Experiments with Adaptive Interim Analyses. Biometrics, 50(4), 1029–1041.
כינויים	non-inferiority trial, bioequivalence study, active-control trial, Denklik ve Üstünlük Olmayan Çalışma (Equivalence / Non-Inferiority)	adaptive design, group sequential design, sample size re-estimation, platform trial
קשורות	6	3
תקציר	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.	Adaptive clinical trial design is a flexible experimental framework, formalised by Bauer and Köhne in 1994, in which pre-specified rules allow the trial to be modified mid-course — adjusting sample size, treatment arms, or randomisation ratios — based on accumulating interim data while rigorously controlling the Type I error rate.