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| Multicentrično ispitivanje faze IV× | Проспективно кохортно истраживање× | |
|---|---|---|
| Oblast | Epidemiologija | Epidemiologija |
| Porodica | Process / pipeline | Process / pipeline |
| Godina nastanka≠ | 1980s–1990s (formalized with post-marketing requirements in modern drug regulation) | 1950s (systematic application); conceptual roots earlier |
| Tvorac≠ | Regulatory agencies and pharmaceutical industry (ICH E2E, FDA, EMA post-marketing frameworks) | Richard Doll and Austin Bradford Hill (landmark application, 1951-1954); cohort methodology formalised by modern epidemiology textbooks |
| Tip≠ | Observational or interventional post-marketing study | Observational longitudinal study design |
| Temeljni izvor≠ | Strom, B. L., & Kimmel, S. E. (Eds.). (2005). Textbook of Pharmacoepidemiology. John Wiley & Sons. ISBN: 978-0470029619 | Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641 |
| Drugi nazivi | multicenter post-marketing study, multicenter pharmacovigilance study, multi-site phase IV study, post-authorization safety study | longitudinal cohort study, prospective follow-up study, incidence study, prospective observational cohort |
| Srodne | 6 | 6 |
| Sažetak≠ | A multicenter Phase IV study is a post-marketing surveillance investigation conducted simultaneously at two or more clinical or research sites after a drug, device, or intervention has received regulatory approval. By pooling real-world data from diverse patient populations and geographic regions, it detects rare adverse events, evaluates long-term effectiveness, characterizes safety in subgroups, and fulfills regulatory post-authorization commitments that single-site studies cannot achieve. | A prospective cohort study assembles a group of participants who are free of the outcome of interest at baseline, measures their exposures, and then follows them forward in time to record who develops the outcome. By collecting exposure data before outcomes occur, it establishes a clear temporal sequence that supports causal inference — a major advantage over retrospective designs. It is the cornerstone observational method in epidemiology and clinical research. |
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