1. Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20–15 DisCoVeRy study
- Author
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Fougerou-Leurent, Claire, Delmas, Christelle, Saillard, Juliette, Dumousseaux, Marina, Ferrane, Assia, Mercier, Noémie, Terzic, Vida, Le Mestre, Soizic, Dechanet, Aline, Belhadi, Drifa, Metois, Annabelle, Burdet, Charles, Mentré, France, Noret, Marion, Diallo, Alpha, Petrov‐sanchez, Ventzislava, Couffin-Cadiergues, Sandrine, Hites, Maya, Ader, Florence, Espérou, Hélène, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Institut de Santé Publique, Université de Médecine Carol Davila, Agence Nationale de Recherches sur le Sida et les Hépatites Virales (ANRS), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Réseau national de recherche clinique en infectiologie (RENARCI), Université libre de Bruxelles (ULB), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), The DisCoVeRy study received funding from European Union Commission (EU-Response, Grant 101015736), French Ministry of Health (PHRC-20-0351), DIM One Health Île-de-France (R20117HD), REACTing, Fonds Erasme-COVID-ULB, and Belgian Health Care Knowledge Centre (KCE), AGMT GmbH, FEDER 'European Regional Development Fund', Portugal Ministry of Health, Portugal Agency for Clinical Research and Biomedical Innovation. Remdesivir was provided free of charge by Gilead.
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Pandemic crisis ,Clinical trials ,Monitoring ,[SDV]Life Sciences [q-bio] ,Quality control ,Sponsoring - Abstract
International audience; Setting: Health measures taken during the pandemic deeply modified the clinical research practices. At the same time, the demand for the results of the COVID-19 trials was urgent. Thus, the objective of this article is to share Inserm's experience in ensuring quality control in clinical trials in this challenging context. Objectives: DisCoVeRy is a phase III randomized study that aimed at evaluating the safety and efficacy of 4 therapeutic strategies in hospitalized COVID-19 adult patients. Between March, 22nd 2020 and January, 20th 2021, 1309 patients were included. In order to guarantee the best quality of data, the Sponsor had to adapt to the current sanitary measures and to their impact on clinical research activity, notably by adapting Monitoring Plan objectives, involving the research departments of the participating hospitals and a network of clinical research assistants (CRAs). Results: Overall, 97 CRAs were involved and performed 909 monitoring visits. The monitoring of 100% of critical data for all patients included in the analysis was achieved, and despite of the pandemic context, a conform consent was recovered for more than 99% of patients. Results of the study were published in May and September 2021. Discussion/conclusion: The main monitoring objective was met thanks to the mobilization of considerable personnel resources, within a very tight time frame and external hurdles. There is a need for further reflection to adapt the lessons learned from this experience to the context of routine practice and to improve the response of French academic research during a future epidemic.
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- 2023