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| Wieloośrodkowe badanie kliniczne III fazy× | Wieloośrodkowe badanie kliniczne z randomizacją× | |
|---|---|---|
| Dziedzina | Epidemiologia | Epidemiologia |
| Rodzina | Process / pipeline | Process / pipeline |
| Rok powstania≠ | 1940s–1990s (formalized through ICH harmonization ~1990s) | 1970s–1980s (widespread adoption for large-scale efficacy trials) |
| Twórca≠ | Codified through ICH E9 guideline (1998) and decades of regulatory practice (FDA, EMA) | 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 |
| Typ≠ | Confirmatory interventional study design | Interventional experimental design |
| Źródło pierwotne | 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 |
| Inne nazwy | Phase III multicenter RCT, confirmatory multicenter trial, Phase 3 multicenter study, pivotal multicenter trial | multi-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled trial |
| Pokrewne | 6 | 6 |
| Podsumowanie≠ | 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 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. |
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