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| Πολυκεντρική Κλινική Δοκιμή Φάσης ΙΙΙ× | Μελέτη Φάσης IV× | |
|---|---|---|
| Πεδίο | Επιδημιολογία | Επιδημιολογία |
| Οικογένεια | Process / pipeline | Process / pipeline |
| Έτος προέλευσης≠ | 1940s–1990s (formalized through ICH harmonization ~1990s) | Formalised 1970s–1990s (ICH E3 guideline 1994) |
| Δημιουργός≠ | Codified through ICH E9 guideline (1998) and decades of regulatory practice (FDA, EMA) | Regulatory agencies and pharmaceutical industry (ICH, FDA, EMA frameworks) |
| Τύπος≠ | Confirmatory interventional study design | Post-marketing observational or interventional study |
| Θεμελιώδης πηγή≠ | 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 | International Conference on Harmonisation (ICH). (1994). ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3. ICH Secretariat. link ↗ |
| Εναλλακτικές ονομασίες | Phase III multicenter RCT, confirmatory multicenter trial, Phase 3 multicenter study, pivotal multicenter trial | post-marketing surveillance study, post-approval study, Phase 4 study, PMS study |
| Συναφείς≠ | 6 | 5 |
| Σύνοψη≠ | 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 IV study is a post-marketing surveillance study conducted after a drug, device, or intervention has received regulatory approval. Its primary purpose is to monitor long-term safety, detect rare adverse events, assess effectiveness in routine clinical practice, and explore new indications or populations not adequately represented in earlier trials. Phase IV evidence accumulates continuously throughout a product's commercial life. |
| ScholarGateΣύνολο δεδομένων ↗ |
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