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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 Jul;116(1):52-63. doi: 10.1002/cpt.3244. Epub 2024 Mar 26. Clin Pharmacol Ther. 2024. PMID: 38529786 Review.
On model-based time trend adjustments in platform trials with non-concurrent controls.
Bofill Roig M, Krotka P, Burman CF, Glimm E, Gold SM, Hees K, Jacko P, Koenig F, Magirr D, Mesenbrink P, Viele K, Posch M. Bofill Roig M, 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.
One Year Outcomes of an International Multicentre Prospective Cohort Study on the Gore Excluder Iliac Branch Endoprosthesis for Aorto-Iliac Aneurysms.
van der Veen D, Holewijn S, Bellosta R, van Sterkenburg SMM, Heyligers JMM, Ficarelli I, Gómez Palonés FJ, Mangialardi N, Mosquera NJ, Holden A, Reijnen MMPJ; IceBERG Study Collaboration. van der Veen D, et al. Eur J Vasc Endovasc Surg. 2021 Aug;62(2):177-185. doi: 10.1016/j.ejvs.2021.04.006. Epub 2021 Jun 16. Eur J Vasc Endovasc Surg. 2021. PMID: 34144884 Free article.
29 results