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Un exemple de réorganisation dans le fonctionnement d’un Centre d’investigations cliniques en période de confinement national suite à la pandémie COVID-19

BACKGROUND: The Clinical Investigations Center of Saint-Louis Hospital (CIC-1427) is a structure dedicated to clinical trials and mainly early phase trials (first-in-man administration, phase 1 and 2). These trials are conducted in a French Regional Health Agency (ARS) authorized structure. In March...

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Autores principales: Ghrieb, Zineb, Allaoua, Souhil, Huang, Jin, Langner, Nathalie, François, Florène, Maréchal, Corinne, Jebali, Majdi, Lebbé, Céleste, Chellah, Abdennour, Bergeron, Anne, Kiladjian, Jean-Jacques, Daltro De Oliveira, Rafael, Soret-Dulphy, Juliette, Benajiba, Lina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Authors. Published by Elsevier Masson SAS on behalf of Société française de pharmacologie et de thérapeutique. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7882219/
https://www.ncbi.nlm.nih.gov/pubmed/33640116
http://dx.doi.org/10.1016/j.therap.2021.02.003
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author Ghrieb, Zineb
Allaoua, Souhil
Huang, Jin
Langner, Nathalie
François, Florène
Maréchal, Corinne
Jebali, Majdi
Lebbé, Céleste
Chellah, Abdennour
Bergeron, Anne
Kiladjian, Jean-Jacques
Daltro De Oliveira, Rafael
Soret-Dulphy, Juliette
Benajiba, Lina
author_facet Ghrieb, Zineb
Allaoua, Souhil
Huang, Jin
Langner, Nathalie
François, Florène
Maréchal, Corinne
Jebali, Majdi
Lebbé, Céleste
Chellah, Abdennour
Bergeron, Anne
Kiladjian, Jean-Jacques
Daltro De Oliveira, Rafael
Soret-Dulphy, Juliette
Benajiba, Lina
author_sort Ghrieb, Zineb
collection PubMed
description BACKGROUND: The Clinical Investigations Center of Saint-Louis Hospital (CIC-1427) is a structure dedicated to clinical trials and mainly early phase trials (first-in-man administration, phase 1 and 2). These trials are conducted in a French Regional Health Agency (ARS) authorized structure. In March 2020, faced to the global COVID-19 pandemic and the French national lockdown measures, the CIC-1427 had to rapidly adapt its operating procedures to ensure the safety of both patients and staff. STUDY OBJECTIVE: Ensuring optimal management of patients included in early phase clinical trials, while respecting the good clinical and professional practices (GCP/GPP) of the CICs protocol sponsors’ requirements, patients’ safety and clinical research multidisciplinary staff safety (nurses, caregivers’ assistants (AS), clinical research assistants (CRA), clinical trial coordinators (CTC), project leaders, health executive and investigating physicians), in the context of the health crisis related to COVID-19. METHODS AND RESULTS: Due to their activity, requiring on-site presence, each staff member of the CIC-1427 clinical research team had to adapt their daily activity to the constraints of the health crisis. New specific procedures were quickly developed to deal with the pandemic. Most of the on-site medical visits were replaced by virtual consults with biological assessments in the local laboratories. “Remote monitoring” replaced on-site monitoring visits. Treatments were sent to each patient's home via couriers after agreement of the CPPs of each protocol (Committee for the Protection of Persons). The essential visits were maintained on site thanks to the unfailing involvement of our clinical care team, with implementation of a specific sanitary protocol. CONCLUSION: The involvement of our entire multidisciplinary research team ensured that each patient was able to benefit from a personalized follow-up and to continue the treatment on-trial. The newly introduced procedures also allowed collection of a maximum of safety and efficacy data for clinical trial sponsors while complying with good regulatory practices. This set of procedures developed during the first epidemic wave, fundamentally helped setting the frame for a better coping during the subsequent pandemic waves.
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spelling pubmed-78822192021-02-16 Un exemple de réorganisation dans le fonctionnement d’un Centre d’investigations cliniques en période de confinement national suite à la pandémie COVID-19 Ghrieb, Zineb Allaoua, Souhil Huang, Jin Langner, Nathalie François, Florène Maréchal, Corinne Jebali, Majdi Lebbé, Céleste Chellah, Abdennour Bergeron, Anne Kiladjian, Jean-Jacques Daltro De Oliveira, Rafael Soret-Dulphy, Juliette Benajiba, Lina Therapie Recherche Clinique BACKGROUND: The Clinical Investigations Center of Saint-Louis Hospital (CIC-1427) is a structure dedicated to clinical trials and mainly early phase trials (first-in-man administration, phase 1 and 2). These trials are conducted in a French Regional Health Agency (ARS) authorized structure. In March 2020, faced to the global COVID-19 pandemic and the French national lockdown measures, the CIC-1427 had to rapidly adapt its operating procedures to ensure the safety of both patients and staff. STUDY OBJECTIVE: Ensuring optimal management of patients included in early phase clinical trials, while respecting the good clinical and professional practices (GCP/GPP) of the CICs protocol sponsors’ requirements, patients’ safety and clinical research multidisciplinary staff safety (nurses, caregivers’ assistants (AS), clinical research assistants (CRA), clinical trial coordinators (CTC), project leaders, health executive and investigating physicians), in the context of the health crisis related to COVID-19. METHODS AND RESULTS: Due to their activity, requiring on-site presence, each staff member of the CIC-1427 clinical research team had to adapt their daily activity to the constraints of the health crisis. New specific procedures were quickly developed to deal with the pandemic. Most of the on-site medical visits were replaced by virtual consults with biological assessments in the local laboratories. “Remote monitoring” replaced on-site monitoring visits. Treatments were sent to each patient's home via couriers after agreement of the CPPs of each protocol (Committee for the Protection of Persons). The essential visits were maintained on site thanks to the unfailing involvement of our clinical care team, with implementation of a specific sanitary protocol. CONCLUSION: The involvement of our entire multidisciplinary research team ensured that each patient was able to benefit from a personalized follow-up and to continue the treatment on-trial. The newly introduced procedures also allowed collection of a maximum of safety and efficacy data for clinical trial sponsors while complying with good regulatory practices. This set of procedures developed during the first epidemic wave, fundamentally helped setting the frame for a better coping during the subsequent pandemic waves. The Authors. Published by Elsevier Masson SAS on behalf of Société française de pharmacologie et de thérapeutique. 2021 2021-02-14 /pmc/articles/PMC7882219/ /pubmed/33640116 http://dx.doi.org/10.1016/j.therap.2021.02.003 Text en © 2021 The Authors Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Recherche Clinique
Ghrieb, Zineb
Allaoua, Souhil
Huang, Jin
Langner, Nathalie
François, Florène
Maréchal, Corinne
Jebali, Majdi
Lebbé, Céleste
Chellah, Abdennour
Bergeron, Anne
Kiladjian, Jean-Jacques
Daltro De Oliveira, Rafael
Soret-Dulphy, Juliette
Benajiba, Lina
Un exemple de réorganisation dans le fonctionnement d’un Centre d’investigations cliniques en période de confinement national suite à la pandémie COVID-19
title Un exemple de réorganisation dans le fonctionnement d’un Centre d’investigations cliniques en période de confinement national suite à la pandémie COVID-19
title_full Un exemple de réorganisation dans le fonctionnement d’un Centre d’investigations cliniques en période de confinement national suite à la pandémie COVID-19
title_fullStr Un exemple de réorganisation dans le fonctionnement d’un Centre d’investigations cliniques en période de confinement national suite à la pandémie COVID-19
title_full_unstemmed Un exemple de réorganisation dans le fonctionnement d’un Centre d’investigations cliniques en période de confinement national suite à la pandémie COVID-19
title_short Un exemple de réorganisation dans le fonctionnement d’un Centre d’investigations cliniques en période de confinement national suite à la pandémie COVID-19
title_sort un exemple de réorganisation dans le fonctionnement d’un centre d’investigations cliniques en période de confinement national suite à la pandémie covid-19
topic Recherche Clinique
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7882219/
https://www.ncbi.nlm.nih.gov/pubmed/33640116
http://dx.doi.org/10.1016/j.therap.2021.02.003
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