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
Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.
Centre d'investigations cliniques (INSERM CIC 1427), Université de Paris, Hôpital Saint-Louis, AP-HP, 75010 Paris, France.
Therapie. 2021 Jul-Aug;76(4):347-358. doi: 10.1016/j.therap.2021.02.003. Epub 2021 Feb 14.
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.
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.
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.
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.
圣路易医院临床研究中心（CIC - 1427）是一个致力于临床试验，主要是早期试验（首次人体给药、1期和2期）的机构。这些试验在法国地区卫生机构（ARS）授权的机构中进行。2020年3月，面对全球新冠疫情和法国全国封锁措施，CIC - 1427不得不迅速调整其操作程序，以确保患者和工作人员的安全。
在与新冠疫情相关的健康危机背景下，确保对早期临床试验中纳入的患者进行最佳管理，同时遵守CICs方案申办者要求的良好临床和专业规范（GCP/GPP）、患者安全以及临床研究多学科工作人员安全（护士、护理助理（AS）、临床研究助理（CRA）、临床试验协调员（CTC）、项目负责人、卫生行政人员和研究医师）。
由于其工作需要现场出勤，CIC - 1427临床研究团队的每位工作人员都必须使其日常活动适应健康危机的限制。迅速制定了新的具体程序来应对疫情。大多数现场医疗问诊被当地实验室进行生物评估的虚拟会诊所取代。“远程监测”取代了现场监测访问。在每个方案的保护人员委员会（CPP）同意后，治疗药物通过快递送到每位患者家中。由于我们临床护理团队的不懈努力，并实施了特定的卫生规程，必要的问诊得以在现场进行。
我们整个多学科研究团队的参与确保了每位患者都能受益于个性化随访并继续试验性治疗。新引入的程序还允许在遵守良好监管规范的同时，为临床试验申办者收集最大量的安全性和有效性数据。在第一波疫情期间制定的这套程序，从根本上为后续疫情波次中更好地应对奠定了框架。
