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Implementation of a Centralized Pharmacovigilance System in Multi-Country European Clinical Trials: Points to Consider for Academic Sponsors and Lessons Learnt from EU-Response and Connect4Children Consortia
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  • Vida Terzić,
  • Léa Levoyer,
  • Mélanie Figarella,
  • Elisabetta Bigagli,
  • Noémie Mercier,
  • Lucie de Gastines,
  • Severine Gibowski,
  • Marius Trøseid,
  • Jacques Demotes,
  • Inge Olsen,
  • Maya Hites,
  • Florence Ader,
  • José Arribas Lopez,
  • France Mentré,
  • Hélèhe Espérou,
  • Dominique Costagliola,
  • John-Arne Røttingen,
  • Julien Poissy,
  • Jean-Christophe Rozé,
  • Adilia Warris,
  • Jackie O'Leary,
  • Ricardo Fernandes,
  • Lambert Assoumou,
  • Régis Hankard,
  • Mark Turner,
  • Yazdan Yazdanpanah,
  • Alpha Diallo
Vida Terzić
ANRS

Corresponding Author:[email protected]

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Léa Levoyer
ANRS
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Mélanie Figarella
ANRS
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Elisabetta Bigagli
University of Florence
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Noémie Mercier
ANRS
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Lucie de Gastines
ANRS
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Severine Gibowski
ANRS
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Marius Trøseid
Oslo University Hospital
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Jacques Demotes
ECRIN
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Inge Olsen
Oslo University Hospital
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Maya Hites
Centre Universitair Bruxelles Hôpital Erasme
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Florence Ader
Hospices Civils de Lyon
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José Arribas Lopez
La Paz University Hospital
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France Mentré
INSERM
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Hélèhe Espérou
INSERM
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Dominique Costagliola
Institut Pierre Louis d'Epidémiologie et de Santé Publique
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John-Arne Røttingen
Norwegian Institute of Public Health
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Julien Poissy
Université de Lille
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Jean-Christophe Rozé
University Hospital Centre Nantes
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Adilia Warris
University of Exeter
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Jackie O'Leary
University College Cork
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Ricardo Fernandes
University of Lisbon Medical Faculty
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Lambert Assoumou
Institut Pierre Louis d'Epidémiologie et de Santé Publique
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Régis Hankard
Université de Tours
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Mark Turner
University of Liverpool
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Yazdan Yazdanpanah
ANRS
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Alpha Diallo
ANRS
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Abstract

Setting-up a high quality and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for industrials. Generating high-quality safety data, compliant with legal and regulatory standards such as European or World Health Organization (WHO), places special requirements on the PV system. The scenario becomes more complicated when dealing with multi-country European clinical trials where heterogeneity on safety process can be encountered. Some Sponsors face these challenges are even more difficult for pediatric trials. A possible solution to ensure that the safety of all participants is equally guaranteed and the PV system fulfills all regulations could be to set up a centralized PV system. This paper introduces the key points to consider when implementing and organizing such system in multi-national European clinical trials. It is based on the Inserm-ANRS MIE pharmacovigilance department’s experience and aims to harmonize and anticipate the needs, in particular by implementing safety procedures and a network of local safety officers. This system is very useful to respond to the challenges of a European clinical trial, notably when considering the complexity of local safety requirements of each country, signal management and the specificities of paediatric regulation.
14 Oct 2022Submitted to British Journal of Clinical Pharmacology
17 Oct 2022Submission Checks Completed
17 Oct 2022Assigned to Editor
17 Oct 2022Review(s) Completed, Editorial Evaluation Pending
21 Oct 2022Reviewer(s) Assigned
06 Nov 2022Editorial Decision: Revise Major
08 Dec 20221st Revision Received
06 Jan 2023Submission Checks Completed
06 Jan 2023Assigned to Editor
06 Jan 2023Review(s) Completed, Editorial Evaluation Pending
11 Jan 2023Reviewer(s) Assigned
13 Jan 2023Editorial Decision: Accept