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| Pragmatikus IV. fázisú tanulmány× | IV. fázisú vizsgálat – Forgalomba hozatalt követő felügyelet× | |
|---|---|---|
| Tudományterület | Epidemiológia | Epidemiológia |
| Módszercsalád | Process / pipeline | Process / pipeline |
| Keletkezés éve≠ | 1967 (pragmatic concept); 2000s (pragmatic Phase IV formalized) | Formalised 1970s–1990s (ICH E3 guideline 1994) |
| Megalkotó≠ | Schwartz & Lellouch (explanatory vs. pragmatic distinction, 1967); PRECIS framework by Thorpe et al. (2009) | Regulatory agencies and pharmaceutical industry (ICH, FDA, EMA frameworks) |
| Típus≠ | Observational / interventional hybrid study design | Post-marketing observational or interventional study |
| Alapmű≠ | Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... & Chalkidou, K. (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Journal of Clinical Epidemiology, 62(5), 464-475. DOI ↗ | International Conference on Harmonisation (ICH). (1994). ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3. ICH Secretariat. link ↗ |
| Alternatív nevek | pragmatic post-marketing study, real-world phase IV trial, pragmatic pharmacovigilance study, pragmatic post-approval study | post-marketing surveillance study, post-approval study, Phase 4 study, PMS study |
| Kapcsolódó | 5 | 5 |
| Összefoglaló≠ | A pragmatic Phase IV study is a post-marketing investigation conducted under routine clinical conditions to evaluate a drug or device's real-world effectiveness, long-term safety, and comparative performance. Unlike the controlled Phase III environment, it intentionally minimizes protocol restrictions — broad eligibility criteria, standard-of-care comparators, and naturalistic follow-up — to generate evidence directly applicable to everyday clinical practice. | 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. |
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