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Page 1
Management of pharmacovigilance during the COVID-19 pandemic crisis by the safety department of an academic sponsor: Lessons learnt and challenges from the EU DisCoVeRy clinical trial.
Mercier N, Belhadi D, DeChanet A, Delmas C, Saillard J, Dumousseaux M, Le Mestre S, Fougerou-Leurent C, Ferrane A, Burdet C, Espérou H, Ader F, Hites M, Peiffer-Smadja N, Poissy J, Andrejak C, Paiva JA, Tacconelli E, Staub T, Greil R, Costagliola D, Mentre F, Yazdanpanah Y, Diallo A; DisCoVeRy Safety Working group. Mercier N, et al. Pharmacol Res Perspect. 2023 Jun;11(3):e01072. doi: 10.1002/prp2.1072. Pharmacol Res Perspect. 2023. PMID: 37269068 Free PMC article. Review.
Tixagevimab-cilgavimab (AZD7442) for the treatment of patients hospitalized with COVID-19 (DisCoVeRy): A phase 3, randomized, double-blind, placebo-controlled trial.
Hites M, Massonnaud CR, Lapique EL, Belhadi D, Jamard S, Goehringer F, Danion F, Reignier J, de Castro N, Garot D, Lacombe K, Tolsma V, Faure E, Malvy D, Staub T, Courjon J, Cazenave-Roblot F, Dyrhol Riise AM, Leturnier P, Martin-Blondel G, Roger C, Akinosoglou K, Moing VL, Piroth L, Sellier P, Lescure X, Trøseid M, Clevenbergh P, Dalgard O, Gallien S, Gousseff M, Loubet P, Vardon-Bounes F, Visée C, Belkhir L, Botelho-Nevers É, Cabié A, Kotanidou A, Lanternier F, Rouveix-Nordon E, Silva S, Thiery G, Poignard P, Carcelain G, Diallo A, Mercier N, Terzic V, Bouscambert-Duchamp M, Gaymard A, Trabaud MA, Destras G, Josset L, Billard N, Han TH, Guedj J, Couffin-Cadiergues S, Dechanet A, Delmas C, Esperou H, Fougerou-Leurent C, Mestre SL, Métois A, Noret M, Bally I, Dergan-Dylon S, Tubiana S, Kalif O, Bergaud N, Leveau B, Eustace J, Greil R, Hajdu E, Halanova M, Paiva JA, Piekarska A, Rodriguez Baño J, Tonby K, Trojánek M, Tsiodras S, Unal S, Burdet C, Costagliola D, Yazdanpanah Y, Peiffer-Smadja N, Mentré F, Ader F; DisCoVeRy study group. Hites M, et al. Among authors: mercier n. J Infect. 2024 Mar;88(3):106120. doi: 10.1016/j.jinf.2024.106120. Epub 2024 Feb 16. J Infect. 2024. PMID: 38367705 Free article. No abstract available.
Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia.
Terzić V, Levoyer L, Figarella M, Bigagli E, Mercier N, De Gastines L, Gibowski S, Trøseid M, Demotes J, Olsen IC, Hites M, Ader F, Lopez JRA, Mentré F, Espérou H, Costagliola D, Røttingen JA, Poissy J, Rozé JC, Warris A, O'Leary J, Fernandes RM, Assoumou L, Hankard R, Turner MA, Yazdanpanah Y, Diallo A; EU-Response safety group; c4c safety group. Terzić V, et al. Among authors: mercier n. Br J Clin Pharmacol. 2023 Apr;89(4):1318-1328. doi: 10.1111/bcp.15669. Epub 2023 Feb 8. Br J Clin Pharmacol. 2023. PMID: 36680782 Free article. Review.
Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial.
Italiano A, Dinart D, Soubeyran I, Bellera C, Espérou H, Delmas C, Mercier N, Albert S, Poignie L, Boland A, Bourdon A, Geneste D, Cavaille Q, Laizet Y, Khalifa E, Auzanneau C, Squiban B, Truffaux N, Olaso R, Gerber Z, Wallet C, Bénard A, Blay JY, Laurent-Puig P, Deleuze JF, Lucchesi C, Mathoulin-Pelissier S; MULTISARC study group. Italiano A, et al. Among authors: mercier n. BMC Cancer. 2021 Nov 5;21(1):1180. doi: 10.1186/s12885-021-08878-2. BMC Cancer. 2021. PMID: 34740331 Free PMC article.
Cardiac Adverse Events and Remdesivir in Hospitalized Patients with Coronavirus Disease 2019 (COVID-19): A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial.
Terzić V, Miantezila Basilua J, Billard N, de Gastines L, Belhadi D, Fougerou-Leurent C, Peiffer-Smadja N, Mercier N, Delmas C, Ferrane A, Dechanet A, Poissy J, Espérou H, Ader F, Hites M, Andrejak C, Greil R, Paiva JA, Staub T, Tacconelli E, Burdet C, Costagliola D, Mentré F, Yazdanpanah Y, Diallo A; DisCoVeRy study group. Terzić V, et al. Among authors: mercier n. Clin Infect Dis. 2024 Mar 29:ciae170. doi: 10.1093/cid/ciae170. Online ahead of print. Clin Infect Dis. 2024. PMID: 38552208
Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20-15 DisCoVeRy study.
Fougerou-Leurent C, Delmas C, Saillard J, Dumousseaux M, Ferrane A, Mercier N, Terzic V, Le Mestre S, Dechanet A, Belhadi D, Metois A, Burdet C, Mentré F, Noret M, Diallo A, Petrov-Sanchez V, Couffin-Cadiergues S, Hites M, Ader F, Esperou H. Fougerou-Leurent C, et al. Among authors: mercier n. Contemp Clin Trials. 2023 Aug;131:107267. doi: 10.1016/j.cct.2023.107267. Epub 2023 Jun 9. Contemp Clin Trials. 2023. PMID: 37302469 Free PMC article.
12 results