Abstract：
BACKGROUND: The study reported the time (from the initial submission to the final decision) to evaluate a clinical research project by one of the 39 French national ethics committees. The times from this final decision to the first participant inclusion and study achievement (first patient inclusion to the end of the last patient\'s follow-up) were also reported.
METHODS: Clinical research projects submitted between January 1st 2019 and June 30th 2023 were analyzed according to their type (research on drugs, clinical investigations, performance studies, research implying human person), and the promotor (industry, university hospital, general hospital, private medical institution, others). The times of assessment of the project by the ethic committee (from the initial submission to the final decision), of the first participant inclusion (from the approval of the project) and of study achievement (first patient inclusion to the end of the last patient\'s follow-up) were calculated.
RESULTS: Among 467 submitted clinical research projects, 424 were approved (90.8 %). The median time [Q1-Q3] to evaluate a project was 73 days [51-98] whatever the types of projects and promotors. In 307 accepted projects, the first patient inclusion occurred after 134 days [61-237] and was being waited for 347 days [306-510] in 39 other ones. In 122 projects, the time for study achievement was 446 days [230-731]. In 185 other projects, the inclusions were still in progress for 699 days [397-1098].
CONCLUSIONS: In this concerned ethic committee, a final decision was edited after a median assessment time of 73 days (with >90 % approvals), shorter than the times to include the first patient and for achieving the study.
METHODS: Clinical research projects submitted between January 1st 2019 and June 30th 2023 were analyzed according to their type (research on drugs, clinical investigations, performance studies, research implying human person), and the promotor (industry, university hospital, general hospital, private medical institution, others). The times of assessment of the project by the ethic committee (from the initial submission to the final decision), of the first participant inclusion (from the approval of the project) and of study achievement (first patient inclusion to the end of the last patient\'s follow-up) were calculated.
RESULTS: Among 467 submitted clinical research projects, 424 were approved (90.8 %). The median time [Q1-Q3] to evaluate a project was 73 days [51-98] whatever the types of projects and promotors. In 307 accepted projects, the first patient inclusion occurred after 134 days [61-237] and was being waited for 347 days [306-510] in 39 other ones. In 122 projects, the time for study achievement was 446 days [230-731]. In 185 other projects, the inclusions were still in progress for 699 days [397-1098].
CONCLUSIONS: In this concerned ethic committee, a final decision was edited after a median assessment time of 73 days (with >90 % approvals), shorter than the times to include the first patient and for achieving the study.
摘要：
背景：该研究报告了法国39个国家伦理委员会之一评估一项临床研究项目的时间（从最初提交到最终决定）。还报告了从最终决定到第一个参与者入选和研究成就（第一个患者入选到最后一个患者随访结束）的时间。
方法：在2019年1月1日至2023年6月30日之间提交的临床研究项目根据其类型进行分析（药物研究，临床调查，绩效研究，暗示人类的研究)，和发起人(工业，大学医院,综合医院,私人医疗机构,其他人)。伦理委员会对项目的评估时间（从最初提交到最终决定），计算第一个参与者纳入(来自项目批准)和研究成果(第一个患者纳入至最后一个患者随访结束).
结果：在467个提交的临床研究项目中，424人获得批准（90.8%）。无论项目和发起人的类型如何，评估项目的中位时间[Q1-Q3]为73天[51-98]。在307个接受的项目中，首例纳入患者发生在134天后[61-237],在其他39例纳入患者中等待了347天[306-510].在122个项目中，完成研究的时间为446天[230-731]。在其他185个项目中，夹杂物仍在进行699天[397-1098]。
结论：在这个有关的伦理委员会中，在中位评估时间为73天(批准>90%)后编辑最终决定，比包括第一位患者和实现研究的时间短。
方法：在2019年1月1日至2023年6月30日之间提交的临床研究项目根据其类型进行分析（药物研究，临床调查，绩效研究，暗示人类的研究)，和发起人(工业，大学医院,综合医院,私人医疗机构,其他人)。伦理委员会对项目的评估时间（从最初提交到最终决定），计算第一个参与者纳入(来自项目批准)和研究成果(第一个患者纳入至最后一个患者随访结束).
结果：在467个提交的临床研究项目中，424人获得批准（90.8%）。无论项目和发起人的类型如何，评估项目的中位时间[Q1-Q3]为73天[51-98]。在307个接受的项目中，首例纳入患者发生在134天后[61-237],在其他39例纳入患者中等待了347天[306-510].在122个项目中，完成研究的时间为446天[230-731]。在其他185个项目中，夹杂物仍在进行699天[397-1098]。
结论：在这个有关的伦理委员会中，在中位评估时间为73天(批准>90%)后编辑最终决定，比包括第一位患者和实现研究的时间短。
