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| Wieloośrodkowe badanie kliniczne fazy II× | Badanie kliniczne z randomizacją (RCT)× | |
|---|---|---|
| Dziedzina | Epidemiologia | Epidemiologia |
| Rodzina | Process / pipeline | Process / pipeline |
| Rok powstania≠ | 1970s–1980s (formalized in regulatory guidance; Simon two-stage design 1989) | 1948 (first rigorously conducted RCT — MRC streptomycin trial) |
| Twórca≠ | Established through ICH and FDA regulatory frameworks; Simon two-stage design formalized by Richard Simon (1989) | Austin Bradford Hill; MRC Streptomycin Trial team |
| Typ≠ | Interventional clinical trial design | Interventional experimental study |
| Źródło pierwotne≠ | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2009). ICH Harmonised Tripartite Guideline: General Considerations for Clinical Studies E8(R1). ICH. link ↗ | 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 | multi-site phase II trial, phase 2 multicenter study, multicenter Phase IIA/IIB trial, multisite efficacy trial | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial |
| Pokrewne | 6 | 6 |
| Podsumowanie≠ | A multicenter phase II clinical trial is an interventional study conducted at two or more independent clinical sites to evaluate the preliminary efficacy and safety of a new treatment in a defined patient population, following demonstrated tolerability in phase I. By pooling patients across sites, the design achieves the sample sizes needed to estimate response rates and identify promising signals before committing to the larger investment of a phase III confirmatory trial. | 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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