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| Dvostruko slepi prilagodljivi eksperiment× | Рандомизовано контролисано испитивање (РКИ)× | |
|---|---|---|
| Oblast | Eksperimentalni dizajn | Eksperimentalni dizajn |
| Porodica≠ | Process / pipeline | Hypothesis test |
| Godina nastanka≠ | Conceptual roots 1970s–1990s; regulatory codification 2004–2019 | 1948 |
| Tvorac≠ | Formalized through FDA adaptive design guidance and work by Scott Berry, Donald Berry, and colleagues | James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948) |
| Tip≠ | Experimental design combining blinding and adaptive modification | Interventional comparative study |
| Temeljni izvor≠ | U.S. Food and Drug Administration. (2019). Adaptive Designs for Clinical Trials of Drugs and Biologics: Guidance for Industry. FDA. 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 ↗ |
| Drugi nazivi | double-blind adaptive design, blinded adaptive trial, double-blind adaptive RCT, adaptive double-blind study | RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı |
| Srodne≠ | 4 | 7 |
| Sažetak≠ | A double-blind adaptive experiment combines two powerful design features: double-blinding, which conceals treatment assignment from both participants and outcome assessors to prevent bias, and adaptive modification, which allows pre-specified changes to the trial's course — such as sample size re-estimation, allocation ratio shifts, or arm dropping — based on accumulating interim data. The result is a rigorous, bias-protected design that can respond to emerging evidence without compromising inferential validity. | 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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