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Authorization of COVID-19 clinical trials: lessons from 2 years of experience of a national competent authority

The COVID-19 pandemic was immediately marked by strong clinical research activity. The French national competent authority presents the data on request for authorization during the first 2 years of COVID-19 pandemic to inform discussions on future clinical research issues. Applications for authoriza...

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Autores principales: Vignot, Stéphane, Dhanani, Alban, Sainte-Marie, Isabelle, de Ligniville Lajavardi, Laure, Even, Gwennaelle, Echemann, Muriel, Hulin, Nina, Ménoret, Claire, Maison, Patrick, Ratignier-Carbonneil, Christelle
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9421368/
https://www.ncbi.nlm.nih.gov/pubmed/36046816
http://dx.doi.org/10.3389/fphar.2022.972660
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author Vignot, Stéphane
Dhanani, Alban
Sainte-Marie, Isabelle
de Ligniville Lajavardi, Laure
Even, Gwennaelle
Echemann, Muriel
Hulin, Nina
Ménoret, Claire
Maison, Patrick
Ratignier-Carbonneil, Christelle
author_facet Vignot, Stéphane
Dhanani, Alban
Sainte-Marie, Isabelle
de Ligniville Lajavardi, Laure
Even, Gwennaelle
Echemann, Muriel
Hulin, Nina
Ménoret, Claire
Maison, Patrick
Ratignier-Carbonneil, Christelle
author_sort Vignot, Stéphane
collection PubMed
description The COVID-19 pandemic was immediately marked by strong clinical research activity. The French national competent authority presents the data on request for authorization during the first 2 years of COVID-19 pandemic to inform discussions on future clinical research issues. Applications for authorization of interventional COVID-19 trials submitted between March 2020 and February 2022 were analysed. Trials on medicinal products were classified according to market authorization status, mechanism of action of the investigational product, target population and clinical context. In 2 years, 208 clinical trials were submitted. 75% were authorized, 3% refused, 22% withdrawn by the sponsor. Among medicinal products trials, 6% were adaptative, 28% included outpatients and 2% were focused on post COVID-19 symptoms. Vaccines were evaluated in 9% of trials, antivirals in 38% and immunomodulators in 35%; 63% of antiviral and 60% of immunomodulation trials included a drug with a marketing authorization in another indication. The dynamics of authorization prove the involvement of stakeholders but also illustrates the risk of dispersion of research efforts and the risk of decorrelation between trials and the epidemic evolution. The high rate of withdrawal of applications could be explained by changes in the sanitary context and by the dropping of some therapeutic approaches. Most of clinical trials evaluate drugs authorized in another indication and assessment procedures by authorities have to mitigate between the knowledge of safety profile of those drugs and the uncertainty in a new clinical context with rapidly evolving knowledge. COVID-19 experience should now support future evolution in clinical research practices.
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spelling pubmed-94213682022-08-30 Authorization of COVID-19 clinical trials: lessons from 2 years of experience of a national competent authority Vignot, Stéphane Dhanani, Alban Sainte-Marie, Isabelle de Ligniville Lajavardi, Laure Even, Gwennaelle Echemann, Muriel Hulin, Nina Ménoret, Claire Maison, Patrick Ratignier-Carbonneil, Christelle Front Pharmacol Pharmacology The COVID-19 pandemic was immediately marked by strong clinical research activity. The French national competent authority presents the data on request for authorization during the first 2 years of COVID-19 pandemic to inform discussions on future clinical research issues. Applications for authorization of interventional COVID-19 trials submitted between March 2020 and February 2022 were analysed. Trials on medicinal products were classified according to market authorization status, mechanism of action of the investigational product, target population and clinical context. In 2 years, 208 clinical trials were submitted. 75% were authorized, 3% refused, 22% withdrawn by the sponsor. Among medicinal products trials, 6% were adaptative, 28% included outpatients and 2% were focused on post COVID-19 symptoms. Vaccines were evaluated in 9% of trials, antivirals in 38% and immunomodulators in 35%; 63% of antiviral and 60% of immunomodulation trials included a drug with a marketing authorization in another indication. The dynamics of authorization prove the involvement of stakeholders but also illustrates the risk of dispersion of research efforts and the risk of decorrelation between trials and the epidemic evolution. The high rate of withdrawal of applications could be explained by changes in the sanitary context and by the dropping of some therapeutic approaches. Most of clinical trials evaluate drugs authorized in another indication and assessment procedures by authorities have to mitigate between the knowledge of safety profile of those drugs and the uncertainty in a new clinical context with rapidly evolving knowledge. COVID-19 experience should now support future evolution in clinical research practices. Frontiers Media S.A. 2022-08-15 /pmc/articles/PMC9421368/ /pubmed/36046816 http://dx.doi.org/10.3389/fphar.2022.972660 Text en Copyright © 2022 Vignot, Dhanani, Sainte-Marie, de Ligniville Lajavardi, Even, Echemann, Hulin, Ménoret, Maison and Ratignier-Carbonneil. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Vignot, Stéphane
Dhanani, Alban
Sainte-Marie, Isabelle
de Ligniville Lajavardi, Laure
Even, Gwennaelle
Echemann, Muriel
Hulin, Nina
Ménoret, Claire
Maison, Patrick
Ratignier-Carbonneil, Christelle
Authorization of COVID-19 clinical trials: lessons from 2 years of experience of a national competent authority
title Authorization of COVID-19 clinical trials: lessons from 2 years of experience of a national competent authority
title_full Authorization of COVID-19 clinical trials: lessons from 2 years of experience of a national competent authority
title_fullStr Authorization of COVID-19 clinical trials: lessons from 2 years of experience of a national competent authority
title_full_unstemmed Authorization of COVID-19 clinical trials: lessons from 2 years of experience of a national competent authority
title_short Authorization of COVID-19 clinical trials: lessons from 2 years of experience of a national competent authority
title_sort authorization of covid-19 clinical trials: lessons from 2 years of experience of a national competent authority
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9421368/
https://www.ncbi.nlm.nih.gov/pubmed/36046816
http://dx.doi.org/10.3389/fphar.2022.972660
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