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طراحی کارآزمایی بالینی تطبیقی×آزمایش برابری / عدمِ‌فوقانی×آزمایش تصادفی کنترل‌شده (RCT)×
حوزهطراحی آزمایشطراحی آزمایشطراحی آزمایش
خانوادهHypothesis testHypothesis testHypothesis test
سال پیدایش199419871948
پدیدآورBauer & KöhneSchuirmann, D.J. / EMA regulatory frameworkJames Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948)
نوعAdaptive hypothesis test with interim analysesParametric equivalence / non-inferiority testInterventional comparative study
منبع بنیادینBauer, 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 ↗
نام‌های دیگرadaptive 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) Tasarımı
مرتبط367
خلاصهAdaptive 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).
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ScholarGateمقایسهٔ روش‌ها: Adaptive Clinical Trial Design · Equivalence / Non-Inferiority Trial · Randomized Controlled Trial. بازیابی‌شده در 2026-06-18 از https://scholargate.app/fa/compare