Clinical trial authorisation: a final look back to better appraise the new European Regulation Experience from ANSM (French National Competent Authority)

Autor: Stéphane Vignot, Gaelle Guyader, Valérie Salomon, Philippe Vella, Isabelle Yoldjian, Patrick Maison, Christelle Ratignier-Carbonneil
Rok vydání: 2023
Předmět:
Zdroj: Reviews on Recent Clinical Trials. 18
ISSN: 1574-8871
DOI: 10.2174/1574887118666230320124012
Popis: 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.
Databáze: OpenAIRE