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| Kockázatkiegyenlített III. fázisú klinikai vizsgálat× | III. fázisú klinikai vizsgálat× | |
|---|---|---|
| Tudományterület | Epidemiológia | Epidemiológia |
| Módszercsalád | Process / pipeline | Process / pipeline |
| Keletkezés éve≠ | 1980s–present | 1962 (Kefauver-Harris Amendment formalised phased drug development) |
| Megalkotó≠ | Evolving practice; foundational risk-adjustment principles established by Pocock (1983) and extended by numerous trialists | FDA regulatory framework / ICH guidelines |
| Típus≠ | Confirmatory randomized trial with baseline risk stratification and covariate adjustment | Confirmatory randomised controlled trial |
| Alapmű≠ | Pocock, S. J. (1983). Clinical Trials: A Practical Approach. Wiley. ISBN: 978-0471901556 | 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 |
| Alternatív nevek | risk-stratified Phase III trial, covariate-adjusted Phase III RCT, risk-adjusted confirmatory trial, RA-Phase III | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT |
| Kapcsolódó | 6 | 6 |
| Összefoglaló≠ | A risk-adjusted Phase III clinical trial is a large-scale confirmatory randomized experiment that explicitly incorporates participants' baseline prognostic risk profile into both the randomization process and the primary statistical analysis. By stratifying patients on known risk factors before allocation and adjusting for those factors in the outcome model, the design achieves greater statistical precision, reduces confounding, and produces treatment effect estimates that are more clinically meaningful across patient subgroups. | 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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