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| Äquivalenz- oder Nichtunterlegenheitsprüfung× | Adaptive Clinical Trial Design× | |
|---|---|---|
| Fachgebiet | Versuchsplanung | Versuchsplanung |
| Familie | Hypothesis test | Hypothesis test |
| Entstehungsjahr≠ | 1987 | 1994 |
| Urheber≠ | Schuirmann, D.J. / EMA regulatory framework | Bauer & Köhne |
| Typ≠ | Parametric equivalence / non-inferiority test | Adaptive hypothesis test with interim analyses |
| Wegweisende Quelle≠ | 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. link ↗ | Bauer, P. & Köhne, K. (1994). Evaluation of Experiments with Adaptive Interim Analyses. Biometrics, 50(4), 1029–1041. DOI ↗ |
| Aliasnamen≠ | 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 |
| Verwandt≠ | 6 | 3 |
| Zusammenfassung≠ | 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. |
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