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| Randomizált klinikai vizsgálat (RCT)× | II. fázisú klinikai vizsgálat – Korai hatékonysági és dózisértékelés× | |
|---|---|---|
| Tudományterület | Epidemiológia | Epidemiológia |
| Módszercsalád | Process / pipeline | Process / pipeline |
| Keletkezés éve≠ | 1948 (first rigorously conducted RCT — MRC streptomycin trial) | 1960s–1970s (formalised in US federal drug regulation) |
| Megalkotó≠ | Austin Bradford Hill; MRC Streptomycin Trial team | U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework) |
| Típus≠ | Interventional experimental study | Interventional clinical study design |
| Alapmű | 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 |
| Alternatív nevek | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial | Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept trial |
| Kapcsolódó | 6 | 6 |
| Összefoglaló≠ | 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. | 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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