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| Многоцентрово рандомизирано клинично изпитване – Многоцентрово РКИ× | Адаптивно рандомизирано клинично изпитване× | |
|---|---|---|
| Област | Епидемиология | Епидемиология |
| Семейство | Process / pipeline | Process / pipeline |
| Година на възникване≠ | 1970s–1980s (widespread adoption for large-scale efficacy trials) | Late 1990s–2000s (widespread adoption post-2010) |
| Създател≠ | Evolved from single-center RCT methodology; consolidated through landmark trials such as the MRC streptomycin trial (1948) and large cardiovascular mega-trials of the 1970s–1980s | Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019 |
| Тип≠ | Interventional experimental design | Experimental clinical trial design |
| Основополагащ източник≠ | Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385 | Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗ |
| Други названия | multi-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled trial | adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial |
| Свързани | 6 | 6 |
| Резюме≠ | A multicenter randomized clinical trial (RCT) is an experimental study in which eligible participants are randomly assigned to intervention or control arms simultaneously across two or more clinical sites. By combining the rigor of randomization with enrollment from geographically or institutionally diverse centers, this design produces large samples and externally valid effect estimates that single-center trials rarely achieve. It is the regulatory gold standard for confirmatory efficacy and safety evaluation of new treatments. | An adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study. |
| ScholarGateНабор от данни ↗ |
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