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| Višecentrično ispitivanje II. faze× | Kliničko ispitivanje faze II× | |
|---|---|---|
| Područje | Epidemiologija | Epidemiologija |
| Obitelj | Process / pipeline | Process / pipeline |
| Godina nastanka≠ | 1970s–1980s (formalized in regulatory guidance; Simon two-stage design 1989) | 1960s–1970s (formalised in US federal drug regulation) |
| Tvorac≠ | Established through ICH and FDA regulatory frameworks; Simon two-stage design formalized by Richard Simon (1989) | U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework) |
| Vrsta≠ | Interventional clinical trial design | Interventional clinical study design |
| Temeljni izvor≠ | 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: 978-3319185392 |
| Drugi nazivi | multi-site phase II trial, phase 2 multicenter study, multicenter Phase IIA/IIB trial, multisite efficacy trial | Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept trial |
| Srodne | 6 | 6 |
| Sažetak≠ | 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 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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