Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20-15 DisCoVeRy study

Abstract

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.

Keywords: Clinical trials; Monitoring; Pandemic crisis; Quality control; Sponsoring.

Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: CFL, VT, ADI, VPS, NM, ADE, AM, FM, DB and FA have nothing to disclose. CB has received consulting fees from MYLAN and Da Volterra and participated on a DSMB for 4Living Biotech. MH has received funding from The Belgian Centre for Knowledge (KCE), the Fonds-Erasme-COVID-19-Université Libre de Bruxelles and an EU-Horizon 2020 grant, payement or honoraria for lectures from Pfizer, Gilead and INSM, support for attending meetings and/or travel from Pfizer and Gilead, participated on a DSMB for Gilead and is President of the Belgian Society of Infectious Diseases and Clinical Microbiology and expert for Belgian Taskforce on COVID therapeutics. The institution employing AF, CD, HE, JS, SCC, MD and SLM received support from the French government, the European Commission, the Region Ile de France, Gilead Sciences, Inc., Sanofi, Merck group and AbbVie for the DisCoVeRy study.

Copyright © 2023. Published by Elsevier Inc.

Figures

Fig. 1

Site initiation visit, green light, and active site in France, within the first 5 weeks of the study. (For interpretation of the references to colour in this figure legend, the reader is referred to the web version of this article.)

Fig. 2

Timeline of site activation and inclusions.

Fig. 3

Monitoring delegation in France, in percentage of recruiting sites.

Fig. 4

Number of monthly inclusions and monitoring visits.