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| Wieloośrodkowe badanie kliniczne fazy II× | Wieloośrodkowe badanie kliniczne z randomizacją× | |
|---|---|---|
| Dziedzina | Epidemiologia | Epidemiologia |
| Rodzina | Process / pipeline | Process / pipeline |
| Rok powstania≠ | 1970s–1980s (formalized in regulatory guidance; Simon two-stage design 1989) | 1970s–1980s (widespread adoption for large-scale efficacy trials) |
| Twórca≠ | Established through ICH and FDA regulatory frameworks; Simon two-stage design formalized by Richard Simon (1989) | 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≠ | Interventional clinical trial design | Interventional experimental design |
| 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 | multi-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled 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 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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