Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation.
Fiche publication
Date publication
janvier 2023
Journal
Reviews on recent clinical trials
Auteurs
Membres identifiés du Cancéropôle Est :
Dr VIGNOT Stéphane
Tous les auteurs :
Vignot S, Guyader G, Salomon V, Vella P, Yoldjian I, Maison P, Ratignier-Carbonneil C
Lien Pubmed
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.
Mots clés
Clinical trials, European regulation, access to innovation, authorisation, indicators, regulatory science
Référence
Rev Recent Clin Trials. 2023 ;18(3):167-171