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Reka Bentuk Ujian Klinikal Adaptif×Ujian Persamaan / Ketidak-inferioran×
BidangReka Bentuk EksperimenReka Bentuk Eksperimen
KeluargaHypothesis testHypothesis test
Tahun asal19941987
PengasasBauer & KöhneSchuirmann, D.J. / EMA regulatory framework
JenisAdaptive hypothesis test with interim analysesParametric equivalence / non-inferiority test
Sumber perintisBauer, 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 ↗
Aliasadaptive design, group sequential design, sample size re-estimation, platform trialnon-inferiority trial, bioequivalence study, active-control trial, Denklik ve Üstünlük Olmayan Çalışma (Equivalence / Non-Inferiority)
Berkaitan36
RingkasanAdaptive 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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ScholarGateBandingkan kaedah: Adaptive Clinical Trial Design · Equivalence / Non-Inferiority Trial. Dicapai 2026-06-18 daripada https://scholargate.app/ms/compare