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| Bayes-féle III. fázisú klinikai vizsgálat× | III. fázisú klinikai vizsgálat× | |
|---|---|---|
| Tudományterület | Epidemiológia | Epidemiológia |
| Módszercsalád | Process / pipeline | Process / pipeline |
| Keletkezés éve≠ | 1990s–2000s (widespread application) | 1962 (Kefauver-Harris Amendment formalised phased drug development) |
| Megalkotó≠ | Donald A. Berry; David J. Spiegelhalter (formalization in clinical context) | FDA regulatory framework / ICH guidelines |
| Típus≠ | Confirmatory randomized controlled trial with Bayesian inference | Confirmatory randomised controlled trial |
| Alapmű≠ | Spiegelhalter, D. J., Abrams, K. R., & Myles, J. P. (2004). Bayesian Approaches to Clinical Trials and Health-Care Evaluation. Wiley. ISBN: 978-0471499756 | 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 | Bayesian confirmatory trial, Bayesian RCT Phase III, Bayesian pivotal trial, BayesCT | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT |
| Kapcsolódó≠ | 5 | 6 |
| Összefoglaló≠ | A Bayesian Phase III clinical trial is a large-scale, confirmatory randomized controlled trial that uses Bayesian statistical inference rather than conventional frequentist hypothesis testing to evaluate whether an experimental treatment meets pre-defined efficacy and safety thresholds. By combining prior evidence with accumulating trial data, it quantifies the probability that the treatment effect exceeds a clinically meaningful threshold, enabling more transparent decision-making under uncertainty. | 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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