Regulatory Issues of Platform Trials: Learnings from EU-PEARL.
Nguyen QL, Hees K, Hernandez Penna S, König F, Posch M, Bofill Roig M, Meyer EL, Freitag MM, Parke T, Otte M, Dauben HP, Mielke T, Spiertz C, Mesenbrink P, Gidh-Jain M, Pierre S, Morello S, Hofner B.
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Clin Pharmacol Ther. 2024 Mar 26. doi: 10.1002/cpt.3244. Online ahead of print.
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PMID: 38529786
Review.
This is supported and complemented by feedback received from regulatory interactions with the European Medicines Agency and the US Food and Drug Administration. Throughout the project we collected the needs of all relevant stakeholders including ethics committees, regulato …
This is supported and complemented by feedback received from regulatory interactions with the European Medicines Agency and the US Fo …