Title :

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

Author(s) :

Mercier, Noémie [Auteur]
Belhadi, Drifa [Auteur]
DeChanet, Aline [Auteur]
Delmas, Christelle [Auteur]
Saillard, Juliette [Auteur]
Dumousseaux, Marina [Auteur]
Le Mestre, Soizic [Auteur]
Fougerou‐Leurent, Claire [Auteur]
Ferrane, Assia [Auteur]
Burdet, Charles [Auteur]
Espérou, Hélène [Auteur]
Ader, Florence [Auteur]
Hites, Maya [Auteur]
Peiffer‐Smadja, Nathan [Auteur]
Poissy, Julien [Auteur]
Unité de Glycobiologie Structurale et Fonctionnelle (UGSF) - UMR 8576
Andrejak, Claire [Auteur]
Paiva, José Artur [Auteur]
Tacconelli, Evelina [Auteur]
Staub, Thérèse [Auteur]
Greil, Richard [Auteur]
Costagliola, Dominique [Auteur]
Mentre, France [Auteur]
Yazdanpanah, Yazdan [Auteur]
Diallo, Alpha [Auteur]

Journal title :

Pharmacology Research & Perspectives

Abbreviated title :

Pharmacology Res & Perspec

Volume number :

11

Pages :

e01072

Publisher :

Wiley

Publication date :

2023-06-02

ISSN :

2052-1707

English keyword(s) :

adverse event
COVID-19
EU-RESPONSE
pandemic crisis
pharmacovigilance

HAL domain(s) :

Sciences du Vivant [q-bio]
Chimie/Chimie théorique et/ou physique

English abstract : [en]

The current COVID‐19 pandemic was an exceptional health situation, including for drug use. As there was no known effective drug for COVID‐19 at the beginning of the pandemic, different drug candidates were proposed. In ...
Show more >The current COVID‐19 pandemic was an exceptional health situation, including for drug use. As there was no known effective drug for COVID‐19 at the beginning of the pandemic, different drug candidates were proposed. In this article, we present the challenges for an academic Safety Department to manage the global safety of a European trial during the pandemic. The National Institute for Health and Medical Research (Inserm) conducted a European multicenter, open‐label, randomized, controlled trial involving three repurposed and one‐in development drugs (lopinavir/ritonavir, IFN‐β1a, hydroxychloroquine, and remdesivir) in adults hospitalized with COVID‐19. From 25 March 2020 to 29 May 2020, the Inserm Safety Department had to manage 585 Serious Adverse Events (SAEs) initial notification and 396 follow‐up reports. The Inserm Safety Department's staff was mobilized to manage these SAEs and to report Expedited safety reports to the competent authorities within the legal timeframes. More than 500 queries were sent to the investigators due to a lack of or incoherent information on SAE forms. At the same time, the investigators were overwhelmed by the management of patients suffering from COVID‐19 infection. These particular conditions of missing data and lack of accurate description of adverse events made evaluation of the SAEs very difficult, particularly the assessment of the causal role of each investigational medicinal product. In parallel, working difficulties were accentuated by the national lockdown, frequent IT tool dysfunctions, delayed implementation of monitoring and the absence of automatic alerts for SAE form modification. Although COVID‐19 is a confounding factor per se, the delay in and quality of SAE form completion and the real‐time medical analysis by the Inserm Safety Department were major issues in the quick identification of potential safety signals. To conduct a high‐quality clinical trial and ensure patient safety, all stakeholders must take their roles and responsibilities.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Other project(s) or funding source(s) :

European Commission, Grant/Award Number: 101015736
Programme Hospitalier de Recherche Clinique, Grant/ Award Number: PHRC-20- 0351
DIM One Health Île-de-France, Grant/Award Number: R20117HD
REACTing

Administrative institution(s) :

Université de Lille
CNRS

Collections :

• Unité de Glycobiologie Structurale et Fonctionnelle (UGSF) - UMR 8576

Research team(s) :

Glycobiology in fungal Pathogenesis and Clinical Applications

Submission date :

2024-03-01T14:41:47Z
2024-03-01T15:32:46Z
2024-03-01T15:35:16Z