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| Kettős vak adaptív kísérlet× | Adaptív randomizált kontrollált vizsgálat× | |
|---|---|---|
| Tudományterület | Kísérlettervezés | Kísérlettervezés |
| Módszercsalád | Process / pipeline | Process / pipeline |
| Keletkezés éve≠ | Conceptual roots 1970s–1990s; regulatory codification 2004–2019 | 1980s–2000s (formalized; earlier sequential testing roots from Wald, 1947) |
| Megalkotó≠ | Formalized through FDA adaptive design guidance and work by Scott Berry, Donald Berry, and colleagues | Donald Berry and others; foundational adaptive trial methods developed through 1980s–2000s biostatistics literature |
| Típus≠ | Experimental design combining blinding and adaptive modification | Experimental design — adaptive variant of RCT |
| Alapmű≠ | U.S. Food and Drug Administration. (2019). Adaptive Designs for Clinical Trials of Drugs and Biologics: Guidance for Industry. FDA. link ↗ | Chow, S.-C., & Chang, M. (2008). Adaptive Design Methods in Clinical Trials. Chapman & Hall/CRC. ISBN: 978-1584887690 |
| Alternatív nevek | double-blind adaptive design, blinded adaptive trial, double-blind adaptive RCT, adaptive double-blind study | Adaptive RCT, Response-adaptive RCT, Adaptive clinical trial, Platform trial |
| Kapcsolódó≠ | 4 | 6 |
| Összefoglaló≠ | 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. | An adaptive randomized controlled trial (adaptive RCT) is an experimental design in which pre-specified rules allow modifications to the trial while it is ongoing — such as changing allocation ratios, dropping underperforming arms, or stopping early for efficacy or futility — based on accumulating interim data. These adaptations are planned before the trial starts and governed by statistical rules to preserve Type I error control and validity. |
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