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| Matchad Fas III-klinisk prövning× | Fas III klinisk prövning – Konfirmerande pivotal studie× | |
|---|---|---|
| Ämnesområde | Epidemiologi | Epidemiologi |
| Familj | Process / pipeline | Process / pipeline |
| Ursprungsår≠ | Mid-20th century (matching in RCTs formalized ~1950s–1970s) | 1962 (Kefauver-Harris Amendment formalised phased drug development) |
| Upphovsperson≠ | Fisher, R. A. (matching principles); adapted into confirmatory trial design over mid-20th century | FDA regulatory framework / ICH guidelines |
| Typ≠ | Controlled confirmatory clinical trial with matching | Confirmatory randomised controlled trial |
| Ursprungskälla≠ | Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641 | 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 |
| Alias | matched controlled Phase III trial, Phase III matched-pair trial, matched confirmatory trial, matched late-phase RCT | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT |
| Närliggande≠ | 5 | 6 |
| Sammanfattning≠ | A matched Phase III clinical trial is a confirmatory, late-stage controlled study in which each participant assigned to the experimental treatment is paired with one or more controls who share key prognostic characteristics — such as age, disease stage, or comorbidities — before treatment allocation. By ensuring baseline comparability at the level of matched pairs, the design reduces confounding and improves statistical efficiency in settings where simple randomization alone may produce imbalanced groups or where full randomization is logistically or ethically constrained. | A Phase III clinical trial is a large-scale, confirmatory randomised controlled trial designed to establish the efficacy and safety of an intervention in the target patient population before regulatory submission. It builds on the signal identified in Phase II, tests the intervention at its proposed dose under controlled conditions, and provides the primary evidence base for marketing authorisation or guideline adoption. |
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