Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation.
Clinical trials
European regulation
access to innovation
authorisation
indicators
regulatory science
Journal
Reviews on recent clinical trials
ISSN: 1876-1038
Titre abrégé: Rev Recent Clin Trials
Pays: United Arab Emirates
ID NLM: 101270873
Informations de publication
Date de publication:
2023
2023
Historique:
received:
12
10
2022
revised:
18
01
2023
accepted:
26
01
2023
medline:
28
8
2023
pubmed:
25
3
2023
entrez:
24
3
2023
Statut:
ppublish
Résumé
The implementation of the new European Clinical Trial Regulation on 31 January 2022, is a major step to promote clinical research in Europe. The French National Agency for Medicines and Health Products Safety (ANSM) proposes to share some key aspects of the preparation for the application of the Regulation initiated in 2017 and to discuss shared indicators that should be considered to monitor clinical trials opportunities on a territory with regards to access to innovation for patients and attractiveness for sponsors. New criteria based on the time from the first request for authorisation to the first inclusion could be of particular interest to appraise the implementation of the European Clinical Trial Regulation.
Identifiants
pubmed: 36959158
pii: RRCT-EPUB-130250
doi: 10.2174/1574887118666230320124012
pmc: PMC10514496
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
167-171Informations de copyright
Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.
Références
Curr Rev Clin Exp Pharmacol. 2022;17(2):114-121
pubmed: 34455953
BMJ Open. 2017 Jul 10;7(7):e015579
pubmed: 28698332
Int J Breast Cancer. 2011;2011:831605
pubmed: 22295234
Sci Eng Ethics. 2016 Apr;22(2):451-66
pubmed: 26037896
Ann Oncol. 2019 Nov 1;30(11):1694-1696
pubmed: 31501860
Value Health. 2021 Dec;24(12):1773-1783
pubmed: 34838275
Health Econ Rev. 2022 Jan 3;12(1):1
pubmed: 34981266
Front Pharmacol. 2022 Aug 15;13:972660
pubmed: 36046816
Lancet. 2016 Jan 23;387(10016):326
pubmed: 26842439