方法对比
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| 等效性/非劣效性试验× | 自适应临床试验设计× | |
|---|---|---|
| 领域 | 实验设计 | 实验设计 |
| 方法族 | Hypothesis test | Hypothesis test |
| 起源年份≠ | 1987 | 1994 |
| 提出者≠ | Schuirmann, D.J. / EMA regulatory framework | Bauer & Köhne |
| 类型≠ | Parametric equivalence / non-inferiority test | Adaptive hypothesis test with interim analyses |
| 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 ↗ | Bauer, P. & Köhne, K. (1994). Evaluation of Experiments with Adaptive Interim Analyses. Biometrics, 50(4), 1029–1041. DOI ↗ |
| 别名≠ | 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 |
| 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. | 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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