학술논문
Controlled human infection trials: Legitimacy and conditions of implementation in France.
Document Type
Academic Journal
Author
Morin AL; Institut Pasteur, 75015 Paris, France. Electronic address: anne-laure.morin@pasteur.fr.; Blanc E; Pfizer, 75014 Paris, France.; Phalipon A; Institut Pasteur, 75015 Paris, France.; Bertoye PH; CNRIPH, ministère de la Santé, 75007 Paris, France.; Amiel P; Inserm, 75654 Paris, France.; Artaud C; AstraZeneca France, 92400 Courbevoie, France.; Barthélemy P; AP-HP, hôpital Antoine-Béclère, 92140 Clamart, France.; Botelho-Nevers E; Hôpital Nord, CHU St-Étienne, 42270 St Priest en Jarez, France.; Courcier S; SC Conseil, 92400 Courbevoie, France.; Cracowski JL; Hôpital Michallon, CHU Grenoble-Alpes, 38700 La Tronche, France.; Eisinger F; Institut Paoli-Calmettes, 13009 Marseille, France.; Forrat R; Sanofi R&D, 69360 Serezin du Rhône, France.; Gruber A; GSK France, 92500 Rueil-Malmaison, France.; Jamrozik E; University of Oxford, United Kingdom; Monash University, University of Melbourne, Melbourne, Australia.; Launay O; Université Paris Cité, AP-HP, CIC vaccinologie Cochin Pasteur, hôpital Cochin, Inserm, FCRIN, I REIVAC, 75014 Paris, France.; Le Jeunne C; Université Paris Cité, AP-HP, Ateliers de Giens, hôpital Cochin, 75014 Paris, France.; Simhon D; Galien Affaires, 75014 Paris, France.
Source
Publisher: Elsevier Masson Country of Publication: France NLM ID: 0420544 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1958-5578 (Electronic) Linking ISSN: 00405957 NLM ISO Abbreviation: Therapie Subsets: MEDLINE
Subject
Language
English
Abstract
This round table is the result of an observation. The observation being that controlled human infection clinical trials (also called "infectious challenge" trials or "Controlled Human Infection Models", "CHIM") recommended or even encouraged in the context of vaccine developments in particular, are not carried out in France. However, there are no formal prohibitions within regulations or ethical principles, which point to the prior assessment of risks and benefits for individuals and for society. The participants in this Round Table thus wished to examine, through the prism of their respective disciplines, the scientific and medical relevance of conducting such trials in France and, if possible, to imagine the conditions under which they would be carried out, thus resulting in recommendations on (1) the advisability of their conduct in France (2), the conditions under which they would be implemented in terms of logistics and regulations, and (3) their social acceptability. The recommendations on which the participants of the Round Table came to an agreement are presented as the analysis progresses.
(Copyright © 2023. Published by Elsevier Masson SAS.)
(Copyright © 2023. Published by Elsevier Masson SAS.)