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| Bayesian Phase III Clinical Trial× | Randomisierte klinische Studie (RCT)× | |
|---|---|---|
| Fachgebiet | Epidemiologie | Epidemiologie |
| Familie | Process / pipeline | Process / pipeline |
| Entstehungsjahr≠ | 1990s–2000s (widespread application) | 1948 (first rigorously conducted RCT — MRC streptomycin trial) |
| Urheber≠ | Donald A. Berry; David J. Spiegelhalter (formalization in clinical context) | Austin Bradford Hill; MRC Streptomycin Trial team |
| Typ≠ | Confirmatory randomized controlled trial with Bayesian inference | Interventional experimental study |
| Wegweisende Quelle≠ | 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 |
| Aliasnamen | Bayesian confirmatory trial, Bayesian RCT Phase III, Bayesian pivotal trial, BayesCT | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial |
| Verwandt≠ | 5 | 6 |
| Zusammenfassung≠ | 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 randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions. |
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