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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

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 mana...

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Autores principales: Mercier, Noémie, Belhadi, Drifa, DeChanet, Aline, Delmas, Christelle, Saillard, Juliette, Dumousseaux, Marina, Le Mestre, Soizic, Fougerou‐Leurent, Claire, Ferrane, Assia, Burdet, Charles, Espérou, Hélène, Ader, Florence, Hites, Maya, Peiffer‐Smadja, Nathan, Poissy, Julien, Andrejak, Claire, Paiva, José Artur, Tacconelli, Evelina, Staub, Thérèse, Greil, Richard, Costagliola, Dominique, Mentre, France, Yazdanpanah, Yazdan, Diallo, Alpha
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10238756/
https://www.ncbi.nlm.nih.gov/pubmed/37269068
http://dx.doi.org/10.1002/prp2.1072
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author Mercier, Noémie
Belhadi, Drifa
DeChanet, Aline
Delmas, Christelle
Saillard, Juliette
Dumousseaux, Marina
Le Mestre, Soizic
Fougerou‐Leurent, Claire
Ferrane, Assia
Burdet, Charles
Espérou, Hélène
Ader, Florence
Hites, Maya
Peiffer‐Smadja, Nathan
Poissy, Julien
Andrejak, Claire
Paiva, José Artur
Tacconelli, Evelina
Staub, Thérèse
Greil, Richard
Costagliola, Dominique
Mentre, France
Yazdanpanah, Yazdan
Diallo, Alpha
author_facet Mercier, Noémie
Belhadi, Drifa
DeChanet, Aline
Delmas, Christelle
Saillard, Juliette
Dumousseaux, Marina
Le Mestre, Soizic
Fougerou‐Leurent, Claire
Ferrane, Assia
Burdet, Charles
Espérou, Hélène
Ader, Florence
Hites, Maya
Peiffer‐Smadja, Nathan
Poissy, Julien
Andrejak, Claire
Paiva, José Artur
Tacconelli, Evelina
Staub, Thérèse
Greil, Richard
Costagliola, Dominique
Mentre, France
Yazdanpanah, Yazdan
Diallo, Alpha
author_sort Mercier, Noémie
collection PubMed
description 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.
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spelling pubmed-102387562023-06-04 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, Noémie Belhadi, Drifa DeChanet, Aline Delmas, Christelle Saillard, Juliette Dumousseaux, Marina Le Mestre, Soizic Fougerou‐Leurent, Claire Ferrane, Assia Burdet, Charles Espérou, Hélène Ader, Florence Hites, Maya Peiffer‐Smadja, Nathan Poissy, Julien Andrejak, Claire Paiva, José Artur Tacconelli, Evelina Staub, Thérèse Greil, Richard Costagliola, Dominique Mentre, France Yazdanpanah, Yazdan Diallo, Alpha Pharmacol Res Perspect Reviews 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. John Wiley and Sons Inc. 2023-06-02 /pmc/articles/PMC10238756/ /pubmed/37269068 http://dx.doi.org/10.1002/prp2.1072 Text en © 2023 The Authors. Pharmacology Research & Perspectives published by British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics and John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Reviews
Mercier, Noémie
Belhadi, Drifa
DeChanet, Aline
Delmas, Christelle
Saillard, Juliette
Dumousseaux, Marina
Le Mestre, Soizic
Fougerou‐Leurent, Claire
Ferrane, Assia
Burdet, Charles
Espérou, Hélène
Ader, Florence
Hites, Maya
Peiffer‐Smadja, Nathan
Poissy, Julien
Andrejak, Claire
Paiva, José Artur
Tacconelli, Evelina
Staub, Thérèse
Greil, Richard
Costagliola, Dominique
Mentre, France
Yazdanpanah, Yazdan
Diallo, Alpha
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10238756/
https://www.ncbi.nlm.nih.gov/pubmed/37269068
http://dx.doi.org/10.1002/prp2.1072
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