השוואת שיטות

	תכנון ניסויים קליניים אדפטיביים	ניסוי שקילות / אי-נחיתות
תחום	תכנון ניסויים	תכנון ניסויים
משפחה	Hypothesis test	Hypothesis test
שנת המקור	1994	1987
הוגה השיטה	Bauer & Köhne	Schuirmann, D.J. / EMA regulatory framework
סוג	Adaptive hypothesis test with interim analyses	Parametric equivalence / non-inferiority test
מקור מכונן	Bauer, P. & Köhne, K. (1994). Evaluation of Experiments with Adaptive Interim Analyses. Biometrics, 50(4), 1029–1041.	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.
כינויים	adaptive design, group sequential design, sample size re-estimation, platform trial	non-inferiority trial, bioequivalence study, active-control trial, Denklik ve Üstünlük Olmayan Çalışma (Equivalence / Non-Inferiority)
קשורות	3	6
תקציר	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.	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.