Porovnat metody
Prohlédněte si vybrané metody vedle sebe; řádky, které se liší, jsou zvýrazněny.
| Zkouška ekvivalence / non-inferiority× | Sekvenční / skupinový sekvenční design studie× | |
|---|---|---|
| Obor | Plánování experimentů | Plánování experimentů |
| Rodina | Hypothesis test | Hypothesis test |
| Rok vzniku≠ | 1987 | 1979 |
| Tvůrce≠ | Schuirmann, D.J. / EMA regulatory framework | O'Brien & Fleming; Pocock; Lan & DeMets |
| Typ≠ | Parametric equivalence / non-inferiority test | Adaptive stopping trial design |
| Původní zdroj≠ | 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 ↗ | O'Brien, P.C. & Fleming, T.R. (1979). A Multiple Testing Procedure for Clinical Trials. Biometrics, 35(3), 549–556. DOI ↗ |
| Další názvy≠ | 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) |
| Příbuzné≠ | 6 | 3 |
| Shrnutí≠ | 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. |
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