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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...
Autores principales: | , , , , , , , , , , , , , |
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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
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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. |
format | Online Article Text |
id | pubmed-7882219 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | The Authors. Published by Elsevier Masson SAS on behalf of Société française de pharmacologie et de thérapeutique. |
record_format | MEDLINE/PubMed |
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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