পদ্ধতির তুলনা করুন
নির্বাচিত পদ্ধতিগুলো পাশাপাশি পর্যালোচনা করুন; যে সারিগুলোয় পার্থক্য আছে সেগুলো চিহ্নিত করা হয়।
| সমতা / অ-নিকৃষ্টতা পরীক্ষা× | সিকোয়েন্সিয়াল / গ্রুপ সিকোয়েন্সিয়াল ট্রায়াল ডিজাইন× | |
|---|---|---|
| ক্ষেত্র | পরীক্ষামূলক নকশা | পরীক্ষামূলক নকশা |
| পরিবার | Hypothesis test | Hypothesis test |
| উদ্ভবের বছর≠ | 1987 | 1979 |
| প্রবর্তক≠ | Schuirmann, D.J. / EMA regulatory framework | O'Brien & Fleming; Pocock; Lan & DeMets |
| ধরন≠ | Parametric equivalence / non-inferiority test | Adaptive stopping trial design |
| মৌলিক উৎস≠ | 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 ↗ | O'Brien, P.C. & Fleming, T.R. (1979). A Multiple Testing Procedure for Clinical Trials. Biometrics, 35(3), 549–556. DOI ↗ |
| অপর নাম≠ | non-inferiority trial, bioequivalence study, active-control trial, Denklik ve Üstünlük Olmayan Çalışma (Equivalence / Non-Inferiority) | group sequential design, adaptive stopping design, Ardışık Deneme Tasarımı (Sequential / Group Sequential) |
| সম্পর্কিত≠ | 6 | 3 |
| সারসংক্ষেপ≠ | 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. | 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. |
| ScholarGateডেটাসেট ↗ |
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