Délai d’obtention d’une première décision finale par un Comité de Protection des Personnes pour débuter une étude de recherche clinique en France : Etude rétrospective entre 2019 et 2023

Abstract

IntroductionThe 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. MethodsClinical 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. ResultsAmong 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]. ConclusionIn 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.