학술논문
[An example of Clinical Investigations Center reorganization during the COVID-19 pandemic French national lockdown].
Document Type
Academic Journal
Author
Ghrieb Z; Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France. Electronic address: zineb.ghrieb@aphp.fr.; Allaoua S; Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.; Huang J; Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.; Langner N; Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.; François F; Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.; Maréchal C; Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.; Jebali M; Service d'oncodermatologie, Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.; Lebbé C; Service d'oncodermatologie, Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.; Chellah A; Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.; Bergeron A; Service de pneumologie, Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.; Kiladjian JJ; Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.; Daltro De Oliveira R; Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.; Soret-Dulphy J; Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.; Benajiba L; Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 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
French
Abstract
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.
(Copyright © 2021 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)
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.
(Copyright © 2021 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)