Bayesian Phase IV study
A Bayesian Phase IV study is a post-marketing research design that applies Bayesian statistical inference to accumulate evidence about a drug or device already approved for clinical use. By formally combining prior evidence from earlier development phases with emerging real-world data, it enables continuous, probabilistic updating of safety and effectiveness estimates — moving beyond the binary hypothesis tests of conventional frequentist surveillance.
Kilderegistrering
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- Spiegelhalter, D. J., Abrams, K. R., & Myles, J. P. (2004). Bayesian Approaches to Clinical Trials and Health-Care Evaluation. Wiley. · ISBN 978-0471499756
- Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. · DOI 10.1038/nrd1927
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