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Health crisis: What opportunities for clinical drug research?

Authors :
Dominique Deplanque
Stanislas Cviklinski
Marc Bardou
Florence Ader
Hervé Blanchard
Philippe Barthélémy
Isabelle David
Eric D’Ortenzio
Hélène Espérou
Odile Launay
Milan Lazarevic
Philippe Lechat
Françoise Lethiec
Yves Levy
David Pérol
Virginie Rage
Matthieu Roustit
Gabriel Thabut
Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 (CIC Lille)
Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)
CHU Lille
Laboratoire Roche SAS [Boulogne Billancourt]
Ministère des Solidarités et de la Santé [Paris, France]
Hôpital de la Croix-Rousse [CHU - HCL]
Hospices Civils de Lyon (HCL)
Pfizer France
Pfizer
AstraZeneca [Courbevoie]
Sanofi Aventis R&D [Chilly-Mazarin]
ANRS - Maladies infectieuses émergentes (ANRS - MIE)
Institut National de la Santé et de la Recherche Médicale (INSERM)
Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137))
Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
Pôle de Recherche Clinique [Paris] (PRC)
CIC Cochin Pasteur (CIC 1417)
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Groupe hospitalier Broca-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)
Hôpital Cochin [AP-HP]
Direction de la Recherche Clinique et de l'Innovation [AP-HP] (DRCI)
Agence Générale des Equipements et Produits de Santé [Paris] (AGEPS)
Janssen-Cilag [Issy-les-Moulineaux]
Institut Mondor de Recherche Biomédicale (IMRB)
Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)
Vaccine Research Institute [Créteil, France] (VRI)
Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)
Centre Léon Bérard [Lyon]
Université de Montpellier (UM)
Centre d'Investigation Clinique [Grenoble] (CIC Grenoble)
CHU Grenoble-Hôpital Michallon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA)
CHU Grenoble
Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble
Source :
Therapie, Therapies, Therapies, 2022, 77 (1), pp.59-67. ⟨10.1016/j.therap.2021.12.008⟩
Publication Year :
2021

Abstract

International audience; The COVID-19 pandemic led to the deployment of an unprecedented academic and industrial research effort, the sometimes redundant nature of which is regrettable, as is the lack of both national and international management. However, it must be noted that during this crisis, regulatory procedures were adapted and certain obstacles in the organisation of clinical research were partly removed to contribute to the deployment of trials as close as possible to patients and to facilitate monitoring and control procedures. The digitisation of certain processes and the decentralisation of certain activities were implemented under the cover of a mobilisation of the authorities and all institutional, academic and industrial players. While in the UK, the optimisation of resources through a single platform trial has made it possible to demonstrate or invalidate the efficacy of many treatments, in France the health crisis has highlighted the fragility of the organisation of clinical research, in particular a lack of coordination and funding, difficulties in implementing studies and a certain reluctance to share data. However, the crisis has also revealed the adaptability of the various stakeholders and has led to the improvement of several processes useful for the deployment of therapeutic innovation. Let us hope that the lessons learned during this crisis will allow for greater efficiency in the event of a new pandemic and, above all, that the progress made will continue to apply to all future clinical research activities.

Details

ISSN :
19585578 and 00405957
Volume :
77
Issue :
1
Database :
OpenAIRE
Journal :
Therapie
Accession number :
edsair.doi.dedup.....23c903350ebfe347c1910e2f1f964d2b
Full Text :
https://doi.org/10.1016/j.therap.2021.12.008⟩