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تصميم التجربة السريرية التكيفي×تجربة التكافؤ / عدم الدونية×التجربة المعشاة ذات الشواهد (RCT)×تصميم التجارب المتسلسل / المتسلسل المجمع×
المجالالتصميم التجريبيالتصميم التجريبيالتصميم التجريبيالتصميم التجريبي
العائلةHypothesis testHypothesis testHypothesis testHypothesis test
سنة النشأة1994198719481979
صاحب الطريقةBauer & KöhneSchuirmann, D.J. / EMA regulatory frameworkJames Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948)O'Brien & Fleming; Pocock; Lan & DeMets
النوعAdaptive hypothesis test with interim analysesParametric equivalence / non-inferiority testInterventional comparative studyAdaptive stopping trial design
المصدر التأسيسيBauer, 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 ↗Schulz, K.F., Altman, D.G., Moher, D., for the CONSORT Group (2010). CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMJ, 340, c332. DOI ↗O'Brien, P.C. & Fleming, T.R. (1979). A Multiple Testing Procedure for Clinical Trials. Biometrics, 35(3), 549–556. DOI ↗
الأسماء البديلةadaptive 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)RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımıgroup sequential design, adaptive stopping design, Ardışık Deneme Tasarımı (Sequential / Group Sequential)
ذات صلة3673
الملخصAdaptive 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.A randomized controlled trial (RCT) is the gold standard experimental design in clinical and health research, in which participants are randomly allocated to a treatment group or a control group so that the effect of an intervention can be measured with the highest possible degree of internal validity. The modern parallel-group RCT was formalized by Austin Bradford Hill and the Medical Research Council in their landmark streptomycin trial of 1948, and its reporting is governed today by the CONSORT 2010 guidelines (Schulz et al., 2010).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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ScholarGateقارن الطرق: Adaptive Clinical Trial Design · Equivalence / Non-Inferiority Trial · Randomized Controlled Trial · Sequential Design. استُرجع بتاريخ 2026-06-18 من https://scholargate.app/ar/compare