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| Многоцентрово клинично изпитване Фаза III× | Рандомизирано контролирано проучване (РКП)× | |
|---|---|---|
| Област | Епидемиология | Епидемиология |
| Семейство | Process / pipeline | Process / pipeline |
| Година на възникване≠ | 1940s–1990s (formalized through ICH harmonization ~1990s) | 1948 (first rigorously conducted RCT — MRC streptomycin trial) |
| Създател≠ | Codified through ICH E9 guideline (1998) and decades of regulatory practice (FDA, EMA) | Austin Bradford Hill; MRC Streptomycin Trial team |
| Тип≠ | Confirmatory interventional study design | Interventional experimental study |
| 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 | 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 |
| Други названия | Phase III multicenter RCT, confirmatory multicenter trial, Phase 3 multicenter study, pivotal multicenter trial | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial |
| Свързани | 6 | 6 |
| Резюме≠ | A multicenter Phase III clinical trial is the definitive confirmatory study that tests whether a new intervention produces a clinically meaningful benefit over a comparator in a large, representative patient population enrolled at two or more independent research sites. It is the primary evidence basis for regulatory approval by agencies such as the FDA and EMA, combining the statistical power of large samples with the external validity gained from geographic and demographic diversity across sites. | A randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions. |
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