Porovnat metody
Prohlédněte si vybrané metody vedle sebe; řádky, které se liší, jsou zvýrazněny.
| Multicentrická klinická studie fáze III× | Klinická studie fáze II× | |
|---|---|---|
| Obor | Epidemiologie | Epidemiologie |
| Rodina | Process / pipeline | Process / pipeline |
| Rok vzniku≠ | 1940s–1990s (formalized through ICH harmonization ~1990s) | 1960s–1970s (formalised in US federal drug regulation) |
| Tvůrce≠ | Codified through ICH E9 guideline (1998) and decades of regulatory practice (FDA, EMA) | U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework) |
| Typ≠ | Confirmatory interventional study design | Interventional clinical study design |
| Původní zdroj | 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: 978-3319185392 |
| Další názvy | Phase III multicenter RCT, confirmatory multicenter trial, Phase 3 multicenter study, pivotal multicenter trial | Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept trial |
| Příbuzné | 6 | 6 |
| Shrnutí≠ | 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 Phase II clinical trial is the second stage in the drug or intervention development pipeline, conducted after Phase I safety testing. Its primary goal is to assess whether the intervention shows preliminary efficacy signals in a relevant patient population at the dose established in Phase I, while continuing to characterise the safety and tolerability profile. Phase II trials are generally smaller than Phase III confirmatory trials and serve as critical go/no-go decision points before large-scale investment. |
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