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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: hernandez penna s. Clin Pharmacol Ther. 2024 Mar 26. doi: 10.1002/cpt.3244. Online ahead of print. Clin Pharmacol Ther. 2024. PMID: 38529786 Review.
Mobilise-D insights to estimate real-world walking speed in multiple conditions with a wearable device.
Kirk C, Küderle A, Micó-Amigo ME, Bonci T, Paraschiv-Ionescu A, Ullrich M, Soltani A, Gazit E, Salis F, Alcock L, Aminian K, Becker C, Bertuletti S, Brown P, Buckley E, Cantu A, Carsin AE, Caruso M, Caulfield B, Cereatti A, Chiari L, D'Ascanio I, Garcia-Aymerich J, Hansen C, Hausdorff JM, Hiden H, Hume E, Keogh A, Kluge F, Koch S, Maetzler W, Megaritis D, Mueller A, Niessen M, Palmerini L, Schwickert L, Scott K, Sharrack B, Sillén H, Singleton D, Vereijken B, Vogiatzis I, Yarnall AJ, Rochester L, Mazzà C, Eskofier BM, Del Din S; Mobilise-D consortium. Kirk C, et al. Sci Rep. 2024 Jan 19;14(1):1754. doi: 10.1038/s41598-024-51766-5. Sci Rep. 2024. PMID: 38243008 Free PMC article.
On the use of wearable sensors as mobility biomarkers in the marketing authorization of new drugs: A regulatory perspective.
Viceconti M, Tome M, Dartee W, Knezevic I, Hernandez Penna S, Mazzà C, Caulfield B, Garcia-Aymerich J, Becker C, Maetzler W, Troosters T, Sharrack B, Davico G, Corriol-Rohou S, Rochester L; Mobilise-D Consortium. Viceconti M, et al. Among authors: hernandez penna s. Front Med (Lausanne). 2022 Sep 21;9:996903. doi: 10.3389/fmed.2022.996903. eCollection 2022. Front Med (Lausanne). 2022. PMID: 36213641 Free PMC article.