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Health crisis: What opportunities for clinical drug research?
Deplanque, Dominique; Cviklinski, Stanislas; Bardou, Marc; Ader, Florence; Blanchard, Hervé; Barthélémy, Philippe; David, Isabelle; D'Ortenzio, Eric; Espérou, Hélène; Launay, Odile; Lazarevic, Milan; Lechat, Philippe; Lethiec, Françoise; Levy, Yves; Pérol, David; Rage, Virginie; Roustit, Matthieu; Thabut, Gabriel.
  • Deplanque D; Inserm, CIC 1403 - centre d'investigation clinique, University Lille, CHU de Lille, 59000 Lille, France. Electronic address: dominique.deplanque@univ-lille.fr.
  • Cviklinski S; Roche SAS - Direction des opérations cliniques, 92100 Boulogne-Billancourt, France.
  • Bardou M; Cellule interministérielle recherche, direction générale de la santé, ministère des Solidarités et de la Santé, 75350 Paris 07 SP, France.
  • Ader F; Département des maladies infectieuses et tropicales, hôpital de la Croix-Rousse, hospices civils de Lyon, 69004 Lyon, France.
  • Blanchard H; Pfizer France, 75014 Paris, France.
  • Barthélémy P; AstraZeneca R&D France, 92400 Courbevoie, France.
  • David I; Sanofi Clinical Study Unit, 91385 Chilly-Mazarin, France.
  • D'Ortenzio E; Inserm ANRS - Maladies infectieuses émergentes, université de Paris - Inserm Infection, Antimicrobien, Modélisation, Evolution (IAME), AP-HP Hôpital Bichat, service de maladies infectieuses et tropicales, Paris, France.
  • Espérou H; Inserm, pôle de recherche clinique, institut de santé publique, 75013 Paris, France.
  • Launay O; Inserm CIC 1417, F-CRIN, COVIREIVAC, AP-HP, hôpital Cochin, 75014 Paris, France.
  • Lazarevic M; DRCI, AP-HP, 75010 Paris, France.
  • Lechat P; AGEPS, Université de Paris, AP-HP, 75005 Paris, France.
  • Lethiec F; Janssen France, 92130 Issy-les-Moulineaux, France.
  • Levy Y; Inserm U955, Team 16, faculté de médecine, Vaccine Research Institute, université Paris-Est Créteil, 94000 Créteil, France.
  • Pérol D; Direction de la recherche clinique et de l'innovation, centre Léon-Bérard, 69008 Lyon, France.
  • Rage V; Laboratoire de droit et économie de la santé, faculté de pharmacie, 34093 Montpellier, France.
  • Roustit M; Inserm CIC1406, University Grenoble Alpes, CHU de Grenoble, 38000 Grenoble, France.
  • Thabut G; AstraZeneca France, 92400 Courbevoie, France.
Therapie ; 77(1): 59-67, 2022.
Article in English | MEDLINE | ID: covidwho-1569090
ABSTRACT
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pandemics / COVID-19 / COVID-19 Drug Treatment Type of study: Observational study / Prognostic study / Randomized controlled trials Limits: Humans Country/Region as subject: Europa Language: English Journal: Therapie Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pandemics / COVID-19 / COVID-19 Drug Treatment Type of study: Observational study / Prognostic study / Randomized controlled trials Limits: Humans Country/Region as subject: Europa Language: English Journal: Therapie Year: 2022 Document Type: Article