Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation

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 Reg...

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Autores principales: Vignot, Stéphane, Guyader, Gaëlle, Salomon, Valérie, Vella, Philippe, Yoldjian, Isabelle, Maison, Patrick, Ratignier-Carbonneil, Christelle
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Bentham Science Publishers 2023
Materias:
Drug Design, Discovery and Therapy, Clinical Trials, Pharmacology, Clinical Trials, Research & Experimental Medicine
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10514496/
https://www.ncbi.nlm.nih.gov/pubmed/36959158
http://dx.doi.org/10.2174/1574887118666230320124012
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author Vignot, Stéphane
Guyader, Gaëlle
Salomon, Valérie
Vella, Philippe
Yoldjian, Isabelle
Maison, Patrick
Ratignier-Carbonneil, Christelle
author_facet Vignot, Stéphane
Guyader, Gaëlle
Salomon, Valérie
Vella, Philippe
Yoldjian, Isabelle
Maison, Patrick
Ratignier-Carbonneil, Christelle
author_sort Vignot, Stéphane
collection PubMed
description 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.
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spelling pubmed-105144962023-09-23 Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation Vignot, Stéphane Guyader, Gaëlle Salomon, Valérie Vella, Philippe Yoldjian, Isabelle Maison, Patrick Ratignier-Carbonneil, Christelle Rev Recent Clin Trials Drug Design, Discovery and Therapy, Clinical Trials, Pharmacology, Clinical Trials, Research & Experimental Medicine 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. Bentham Science Publishers 2023-08-15 2023-08-15 /pmc/articles/PMC10514496/ /pubmed/36959158 http://dx.doi.org/10.2174/1574887118666230320124012 Text en © 2023 Bentham Science Publishers https://creativecommons.org/licenses/by/4.0/© 2023 The Author(s). Published by Bentham Science Publisher. This is an open access article published under CC BY 4.0 https://creativecommons.org/licenses/by/4.0/legalcode)
spellingShingle Drug Design, Discovery and Therapy, Clinical Trials, Pharmacology, Clinical Trials, Research & Experimental Medicine
Vignot, Stéphane
Guyader, Gaëlle
Salomon, Valérie
Vella, Philippe
Yoldjian, Isabelle
Maison, Patrick
Ratignier-Carbonneil, Christelle
Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation
title Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation
title_full Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation
title_fullStr Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation
title_full_unstemmed Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation
title_short Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation
title_sort clinical trial authorisation: a final look back to better appraise the new european regulation
topic Drug Design, Discovery and Therapy, Clinical Trials, Pharmacology, Clinical Trials, Research & Experimental Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10514496/
https://www.ncbi.nlm.nih.gov/pubmed/36959158
http://dx.doi.org/10.2174/1574887118666230320124012
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