方法对比
并排查看您选择的方法；存在差异的行会高亮显示。
| 等效性/非劣效性试验× | 顺序/分组顺序试验设计× | |
|---|---|---|
| 领域 | 实验设计 | 实验设计 |
| 方法族 | Hypothesis test | Hypothesis test |
| 起源年份≠ | 1987 | 1979 |
| 提出者≠ | Schuirmann, D.J. / EMA regulatory framework | O'Brien & Fleming; Pocock; Lan & DeMets |
| 类型≠ | Parametric equivalence / non-inferiority test | Adaptive stopping trial design |
| 开创性文献≠ | 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 ↗ |
| 别名≠ | 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) |
| 相关≠ | 6 | 3 |
| 摘要≠ | 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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