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| 실용적 무작위 대조 시험× | 적응형 무작위 배정 임상시험× | |
|---|---|---|
| 분야 | 실험설계 | 실험설계 |
| 계열 | Process / pipeline | Process / pipeline |
| 기원 연도≠ | 1967 | 1980s–2000s (formalized; earlier sequential testing roots from Wald, 1947) |
| 창시자≠ | Daniel Schwartz and Joseph Lellouch | Donald Berry and others; foundational adaptive trial methods developed through 1980s–2000s biostatistics literature |
| 유형≠ | Experimental design — pragmatic trial | Experimental design — adaptive variant of RCT |
| 원전≠ | Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648. DOI ↗ | Chow, S.-C., & Chang, M. (2008). Adaptive Design Methods in Clinical Trials. Chapman & Hall/CRC. ISBN: 978-1584887690 |
| 별칭 | pRCT, pragmatic trial, practical clinical trial, real-world RCT | Adaptive RCT, Response-adaptive RCT, Adaptive clinical trial, Platform trial |
| 관련≠ | 4 | 6 |
| 요약≠ | A pragmatic randomized controlled trial (pRCT) tests whether an intervention works under ordinary, real-world conditions — broad eligibility, flexible delivery, and routine care settings. Participants are still randomly assigned to treatment or control, preserving causal inference, but the study is designed to reflect the diversity and variability of actual practice rather than the ideal conditions of an explanatory trial. The defining framework is the PRECIS-2 tool, which maps any RCT along nine pragmatic-to-explanatory dimensions. | 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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