EMA posts for comment a "Concept Paper for the Development of a Reflection Paper on the use of Bayesian methods in clinical development"
Those interested in commenting have until 30April2026 to comment. A link to the Concept Paper is below.
It will be interesting to see how different the EMA approach is from that taken by the FDA in their draft guidance "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products" posted for comment just two weeks ago.
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-use-bayesian-methods-clinical-development_en.pdf
#EMA #ClinicalDevelopment #BayesianMethodology
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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