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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. Among authors: hites m. Pharmacol Res Perspect. 2023 Jun;11(3):e01072. doi: 10.1002/prp2.1072. Pharmacol Res Perspect. 2023. PMID: 37269068 Free PMC article. Review.
Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial.
Ader F, Bouscambert-Duchamp M, Hites M, Peiffer-Smadja N, Poissy J, Belhadi D, Diallo A, Lê MP, Peytavin G, Staub T, Greil R, Guedj J, Paiva JA, Costagliola D, Yazdanpanah Y, Burdet C, Mentré F; DisCoVeRy Study Group. Ader F, et al. Among authors: hites m. Lancet Infect Dis. 2022 Feb;22(2):209-221. doi: 10.1016/S1473-3099(21)00485-0. Epub 2021 Sep 14. Lancet Infect Dis. 2022. PMID: 34534511 Free PMC article. Clinical Trial.
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: hites m. 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.
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: hites m. 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.
Association between SARS-CoV-2 viral kinetics and clinical score evolution in hospitalized patients.
Néant N, Lingas G, Gaymard A, Belhadi D, Hites M, Staub T, Greil R, Paiva JA, Poissy J, Peiffer-Smadja N, Costagliola D, Yazdanpanah Y, Bouscambert-Duchamp M, Gagneux-Brunon A, Ader F, Mentré F, Wallet F, Burdet C, Guedj J; DisCoVeRy study group. Néant N, et al. Among authors: hites m. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2027-2037. doi: 10.1002/psp4.13051. Epub 2023 Oct 11. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 37728045 Free PMC article. Clinical Trial.
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: hites m. Clin Infect Dis. 2024 Mar 29:ciae170. doi: 10.1093/cid/ciae170. Online ahead of print. Clin Infect Dis. 2024. PMID: 38552208
Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial.
Thompson GR 3rd, Soriano A, Cornely OA, Kullberg BJ, Kollef M, Vazquez J, Honore PM, Bassetti M, Pullman J, Chayakulkeeree M, Poromanski I, Dignani C, Das AF, Sandison T, Pappas PG; ReSTORE trial investigators. Thompson GR 3rd, et al. Lancet. 2023 Jan 7;401(10370):49-59. doi: 10.1016/S0140-6736(22)02324-8. Epub 2022 Nov 25. Lancet. 2023. PMID: 36442484 Free article. Clinical Trial.
87 results