Authorization of COVID-19 clinical trials: lessons from 2 years of experience of a national competent authority.
Fiche publication
Date publication
août 2022
Journal
Frontiers in pharmacology
Auteurs
Membres identifiés du Cancéropôle Est :
Dr VIGNOT Stéphane
Tous les auteurs :
Vignot S, Dhanani A, Sainte-Marie I, de Ligniville Lajavardi L, Even G, Echemann M, Hulin N, Ménoret C, Maison P, Ratignier-Carbonneil C
Lien Pubmed
Résumé
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 In 2 years, 208 clinical trials were submitted. 75% were authorized, 3% refused, 22% withdrawn by the sponsor.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.
Mots clés
COVID-19, clinical trials, national competent authorities, regulatory science, repurposing strategies
Référence
Front Pharmacol. 2022 08 15;13:972660