Authorization of COVID-19 clinical trials: lessons from 2 years of experience of a national competent authority.
COVID-19
clinical trials
national competent authorities
regulatory science
repurposing strategies
Journal
Frontiers in pharmacology
ISSN: 1663-9812
Titre abrégé: Front Pharmacol
Pays: Switzerland
ID NLM: 101548923
Informations de publication
Date de publication:
2022
2022
Historique:
received:
18
06
2022
accepted:
04
07
2022
entrez:
1
9
2022
pubmed:
2
9
2022
medline:
2
9
2022
Statut:
epublish
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 In 2 years, 208 clinical trials were submitted. 75% were authorized, 3% refused, 22% withdrawn by the sponsor.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.
Identifiants
pubmed: 36046816
doi: 10.3389/fphar.2022.972660
pii: 972660
pmc: PMC9421368
doi:
Types de publication
Journal Article
Langues
eng
Pagination
972660Informations de copyright
Copyright © 2022 Vignot, Dhanani, Sainte-Marie, de Ligniville Lajavardi, Even, Echemann, Hulin, Ménoret, Maison and Ratignier-Carbonneil.
Déclaration de conflit d'intérêts
Authors SV, AD, IS, LL, GE, ME, NH, CM, PM, and CR-C are employed by Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM).
Références
JAMA Netw Open. 2021 May 3;4(5):e218828
pubmed: 33938933
Thorax. 2021 Sep;76(9):907-919
pubmed: 33579777
Drug Discov Today. 2022 Jul;27(7):1874-1894
pubmed: 35427764
Br J Anaesth. 2022 Feb;128(2):352-362
pubmed: 34774295
N Engl J Med. 2020 Aug 6;383(6):517-525
pubmed: 32492293
Infect Dis Now. 2021 Nov;51(8):641-646
pubmed: 34464755
Lancet Oncol. 2019 Jun;20(6):e336-e342
pubmed: 31162107
Bull Cancer. 2020 Jun;107(6):617-619
pubmed: 32414537
Crit Care. 2021 Jul 30;25(1):268
pubmed: 34330320
Med Mal Infect. 2020 Jun;50(4):384
pubmed: 32240719
Cochrane Database Syst Rev. 2021 Aug 16;8:CD014963
pubmed: 34396514
Drug Discov Today. 2021 Feb;26(2):283-288
pubmed: 33127567
Molecules. 2022 Apr 23;27(9):
pubmed: 35566073
Lancet. 2020 Jun 27;395(10242):1970-1971
pubmed: 32559417
N Engl J Med. 2021 Feb 25;384(8):693-704
pubmed: 32678530
BMJ. 2020 May 14;369:m1849
pubmed: 32409561
JAMA. 2020 Jan 7;323(1):17
pubmed: 31910262
JAMA. 2020 Oct 6;324(13):1307-1316
pubmed: 32876695
Nat Commun. 2020 Aug 26;11(1):4253
pubmed: 32848158
JAMA. 2021 Aug 10;326(6):499-518
pubmed: 34228774