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Reviews on Recent Clinical Trials

Editor-in-Chief

ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

Perspective

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

Author(s): Stéphane Vignot*, Gaelle Guyader, Valérie Salomon, Philippe Vella, Isabelle Yoldjian, Patrick Maison and Christelle Ratignier-Carbonneil

Volume 18, Issue 3, 2023

Published on: 31 July, 2023

Page: [167 - 171] Pages: 5

DOI: 10.2174/1574887118666230320124012

open access plus

Abstract

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.

Keywords: Clinical trials, regulatory science, access to innovation, European regulation, authorisation, indicators.

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Graphical Abstract
[1]
Giannuzzi V, Altavilla A, Ruggieri L, Ceci A. Clinical trial application in Europe: What will change with the new regulation? Sci Eng Ethics 2016; 22(2): 451-66.
[http://dx.doi.org/10.1007/s11948-015-9662-0] [PMID: 26037896]
[2]
Dombernowsky T, Hædersdal M, Lassen U, Thomsen SF. Development in the number of clinical trial applications in Western Europe from 2007 to 2015: Retrospective study of data from national competent authorities. BMJ Open 2017; 7(7): e015579.
[http://dx.doi.org/10.1136/bmjopen-2016-015579] [PMID: 28698332]
[3]
Casassus B. France investigates drug trial disaster. Lancet 2016; 387(10016): 326.
[http://dx.doi.org/10.1016/S0140-6736(16)00154-9] [PMID: 26842439]
[4]
Vignot S, Martin M, Albin N, Schurtz C, Chapel E. Facilitating access to new therapeutic options through clinical trials: The vision of a regulator to reconcile innovation and safety. Ann Oncol 2019; 30(11): 1694-6.
[http://dx.doi.org/10.1093/annonc/mdz389] [PMID: 31501860]
[5]
ICH S9 Non-clinical evaluation for anticancer pharmaceuticals. Available from: https://www.ema.europa.eu/en/ich-s9-non-clinical-evaluation-anticancer-pharmaceuticals (Accessed on: 10 OCT 2022).
[6]
Patkar V, Acosta D, Davidson T, Jones A, Fox J, Keshtgar M. Cancer multidisciplinary team meetings: Evidence, challenges, and the role of clinical decision support technology. Int J Breast Cancer 2011; 2011: 1-7.
[http://dx.doi.org/10.4061/2011/831605] [PMID: 22295234]
[7]
Clinical trials on medicinal products submitted to the ANSM as part of the Fast-Track procedure. Available from: https://ansm.sante.fr/uploads/2021/02/17/aec-doc020a-v02-practical-guide-fast-track-18022019-en-1.pdf (Accessed on: 10 OCT 2022).
[8]
Vignot S, Dhanani A, Sainte-Marie I, et al. Authorization of COVID-19 clinical trials: Lessons from 2 years of experience of a national competent authority. Front Pharmacol 2022; 13: 972660.
[http://dx.doi.org/10.3389/fphar.2022.972660] [PMID: 36046816]
[9]
Ravi R, Kesari HV. Novel study designs in precision medicine-basket, umbrella and platform trials. Curr Rev Clin Exp Pharmacol 2022; 17(2): 114-21.
[10]
Hofmann S, Branner J, Misra A, Lintener H. A review of current approaches to defining and valuing innovation in health technology assessment. Value Health 2021; 24(12): 1773-83.
[http://dx.doi.org/10.1016/j.jval.2021.06.006] [PMID: 34838275]
[11]
Rejon-Parrilla JC, Espin J, Epstein D. How innovation can be defined, evaluated and rewarded in health technology assessment. Health Econ Rev 2022; 12(1): 1.
[http://dx.doi.org/10.1186/s13561-021-00342-y] [PMID: 34981266]
[12]
HMA, European Commission, EMA. Recommendation paper on decentralised elements in clinical trials. 2022. Available from: https://health.ec.europa.eu/system/files/2022-12/mp_decentralised-elements_clinical-trials_rec_en.pdf (Accessed on: 18 JAN 2023).

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