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| Thiết kế thử nghiệm lâm sàng thích ứng× | Thử nghiệm Tương đương / Không kém hơn× | |
|---|---|---|
| Lĩnh vực | Thiết kế thí nghiệm | Thiết kế thí nghiệm |
| Họ | Hypothesis test | Hypothesis test |
| Năm ra đời≠ | 1994 | 1987 |
| Người khởi xướng≠ | Bauer & Köhne | Schuirmann, D.J. / EMA regulatory framework |
| Loại≠ | Adaptive hypothesis test with interim analyses | Parametric equivalence / non-inferiority test |
| Công trình gốc≠ | Bauer, P. & Köhne, K. (1994). Evaluation of Experiments with Adaptive Interim Analyses. Biometrics, 50(4), 1029–1041. DOI ↗ | 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 ↗ |
| Tên gọi khác≠ | adaptive design, group sequential design, sample size re-estimation, platform trial | non-inferiority trial, bioequivalence study, active-control trial, Denklik ve Üstünlük Olmayan Çalışma (Equivalence / Non-Inferiority) |
| Liên quan≠ | 3 | 6 |
| Tóm tắt≠ | 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. | 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. |
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