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| Pragmaattinen satunnaistettu kontrolloitu tutkimus× | Vaiheen IV tutkimus – Markkinoille tulon jälkeinen seuranta× | |
|---|---|---|
| Tieteenala | Epidemiologia | Epidemiologia |
| Menetelmäperhe | Process / pipeline | Process / pipeline |
| Syntyvuosi≠ | 1967 | Formalised 1970s–1990s (ICH E3 guideline 1994) |
| Kehittäjä≠ | Daniel Schwartz & Joseph Lellouch | Regulatory agencies and pharmaceutical industry (ICH, FDA, EMA frameworks) |
| Tyyppi≠ | Interventional study design | Post-marketing observational or interventional study |
| Alkuperäislähde≠ | Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648. DOI ↗ | International Conference on Harmonisation (ICH). (1994). ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3. ICH Secretariat. link ↗ |
| Rinnakkaisnimet | pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial | post-marketing surveillance study, post-approval study, Phase 4 study, PMS study |
| Liittyvät≠ | 6 | 5 |
| Tiivistelmä≠ | A pragmatic randomized clinical trial (pragmatic RCT) is an interventional study that tests whether a treatment works under routine clinical conditions, as opposed to the tightly controlled setting of an explanatory trial. It prioritizes broad eligibility, flexible delivery, and patient-relevant outcomes to answer the question 'Does this treatment work in everyday practice?' rather than 'Can this treatment work under ideal circumstances?' The distinction between pragmatic and explanatory trials was formally articulated by Schwartz and Lellouch in 1967 and operationalized by the PRECIS tool in 2009. | 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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