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Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20–15 DisCoVeRy study
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10250249/ https://www.ncbi.nlm.nih.gov/pubmed/37302469 http://dx.doi.org/10.1016/j.cct.2023.107267 |
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author | 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 Esperou, Hélène |
author_facet | 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 Esperou, Hélène |
author_sort | Fougerou-Leurent, Claire |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10250249 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-102502492023-06-09 Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20–15 DisCoVeRy study 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 Esperou, Hélène Contemp Clin Trials Article 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. Elsevier Inc. 2023-08 2023-06-09 /pmc/articles/PMC10250249/ /pubmed/37302469 http://dx.doi.org/10.1016/j.cct.2023.107267 Text en © 2023 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Article 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 Esperou, Hélène Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20–15 DisCoVeRy study |
title | Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20–15 DisCoVeRy study |
title_full | Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20–15 DisCoVeRy study |
title_fullStr | Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20–15 DisCoVeRy study |
title_full_unstemmed | Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20–15 DisCoVeRy study |
title_short | Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20–15 DisCoVeRy study |
title_sort | ensuring quality control in a covid-19 clinical trial during the pandemic: the experience of the inserm c20–15 discovery study |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10250249/ https://www.ncbi.nlm.nih.gov/pubmed/37302469 http://dx.doi.org/10.1016/j.cct.2023.107267 |
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