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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: hees k. Clin Pharmacol Ther. 2024 Mar 26. doi: 10.1002/cpt.3244. Online ahead of print. Clin Pharmacol Ther. 2024. PMID: 38529786 Review.
On model-based time trend adjustments in platform trials with non-concurrent controls.
Roig MB, Krotka P, Burman CF, Glimm E, Gold SM, Hees K, Jacko P, Koenig F, Magirr D, Mesenbrink P, Viele K, Posch M. Roig MB, et al. Among authors: hees k. BMC Med Res Methodol. 2022 Aug 15;22(1):228. doi: 10.1186/s12874-022-01683-w. BMC Med Res Methodol. 2022. PMID: 35971069 Free PMC article. Clinical Trial.
Long-Term Outcome of Steroid-Resistant Nephrotic Syndrome in Children.
Trautmann A, Schnaidt S, Lipska-Ziętkiewicz BS, Bodria M, Ozaltin F, Emma F, Anarat A, Melk A, Azocar M, Oh J, Saeed B, Gheisari A, Caliskan S, Gellermann J, Higuita LMS, Jankauskiene A, Drozdz D, Mir S, Balat A, Szczepanska M, Paripovic D, Zurowska A, Bogdanovic R, Yilmaz A, Ranchin B, Baskin E, Erdogan O, Remuzzi G, Firszt-Adamczyk A, Kuzma-Mroczkowska E, Litwin M, Murer L, Tkaczyk M, Jardim H, Wasilewska A, Printza N, Fidan K, Simkova E, Borzecka H, Staude H, Hees K, Schaefer F; PodoNet Consortium. Trautmann A, et al. Among authors: hees k. J Am Soc Nephrol. 2017 Oct;28(10):3055-3065. doi: 10.1681/ASN.2016101121. Epub 2017 May 31. J Am Soc Nephrol. 2017. PMID: 28566477 Free PMC article.
29 results