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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. Nguyen QL, et al. Among authors: spiertz c. Clin Pharmacol Ther. 2024 Jul;116(1):52-63. doi: 10.1002/cpt.3244. Epub 2024 Mar 26. Clin Pharmacol Ther. 2024. PMID: 38529786 Review.
Electronic health records (EHRs) in clinical research and platform trials: Application of the innovative EHR-based methods developed by EU-PEARL.
Lombardo G, Couvert C, Kose M, Begum A, Spiertz C, Worrell C, Hasselbaink D, Didden EM, Sforzini L, Todorovic M, Lewi M, Brown M, Vaterkowski M, Gullet N, Amasi-Hartoonian N, Griffon N, Pais R, Rodriguez Navarro S, Kremer A, Maes C, Tan EH, Moinat M, Ferrer JG, Pariante CM, Kalra D, Ammour N, Kalko S. Lombardo G, et al. Among authors: spiertz c. J Biomed Inform. 2023 Dec;148:104553. doi: 10.1016/j.jbi.2023.104553. Epub 2023 Nov 22. J Biomed Inform. 2023. PMID: 38000766 Free article.