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| Badanie równoważności / niegorszości× | Analiza sekwencyjna (grupowy plan sekwencyjny)× | |
|---|---|---|
| Dziedzina≠ | Planowanie eksperymentów | Statystyka |
| Rodzina | Hypothesis test | Hypothesis test |
| Rok powstania≠ | 1987 | 1977 |
| Twórca≠ | Schuirmann, D.J. / EMA regulatory framework | P. C. O'Brien & T. R. Fleming; P. C. Pocock |
| Typ≠ | Parametric equivalence / non-inferiority test | Sequential / adaptive hypothesis test |
| Źródło pierwotne≠ | 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 ↗ |
| Inne nazwy | 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) |
| Pokrewne≠ | 6 | 5 |
| Podsumowanie≠ | 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. |
| ScholarGateZbiór danych ↗ |
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