{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T12:05:53Z","timestamp":1784808353496,"version":"3.55.0"},"reference-count":10,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,6,2]],"date-time":"2023-06-02T00:00:00Z","timestamp":1685664000000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2023,6,1]],"date-time":"2023-06-01T00:00:00Z","timestamp":1685577600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100000780","name":"European Commission","doi-asserted-by":"publisher","award":["101015736"],"award-info":[{"award-number":["101015736"]}],"id":[{"id":"10.13039\/501100000780","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacology Res & Perspec"],"published-print":{"date-parts":[[2023,6]]},"abstract":"Abstract<\/jats:title>\n \n The current COVID\u201019 pandemic was an exceptional health situation, including for drug use. As there was no known effective drug for COVID\u201019 at the beginning of the pandemic, different drug candidates were proposed. In this article, we present the challenges for an academic Safety Department to manage the global safety of a European trial during the pandemic. The National Institute for Health and Medical Research (Inserm) conducted a European multicenter, open\u2010label, randomized, controlled trial involving three repurposed and one\u2010in development drugs (\n lopinavir<\/jats:ext-link>\n \/\n ritonavir<\/jats:ext-link>\n ,\n IFN\u2010\u03b21a<\/jats:ext-link>\n ,\n hydroxychloroquine<\/jats:ext-link>\n , and\n remdesivir<\/jats:ext-link>\n ) in adults hospitalized with COVID\u201019. From 25 March 2020 to 29 May 2020, the Inserm Safety Department had to manage 585 Serious Adverse Events (SAEs) initial notification and 396 follow\u2010up reports. The Inserm Safety Department's staff was mobilized to manage these SAEs and to report Expedited safety reports to the competent authorities within the legal timeframes. More than 500 queries were sent to the investigators due to a lack of or incoherent information on SAE forms. At the same time, the investigators were overwhelmed by the management of patients suffering from COVID\u201019 infection. These particular conditions of missing data and lack of accurate description of adverse events made evaluation of the SAEs very difficult, particularly the assessment of the causal role of each investigational medicinal product. In parallel, working difficulties were accentuated by the national lockdown, frequent IT tool dysfunctions, delayed implementation of monitoring and the absence of automatic alerts for SAE form modification. Although COVID\u201019 is a confounding factor per se, the delay in and quality of SAE form completion and the real\u2010time medical analysis by the Inserm Safety Department were major issues in the quick identification of potential safety signals. To conduct a high\u2010quality clinical trial and ensure patient safety, all stakeholders must take their roles and responsibilities.\n <\/jats:p>","DOI":"10.1002\/prp2.1072","type":"journal-article","created":{"date-parts":[[2023,6,3]],"date-time":"2023-06-03T00:51:05Z","timestamp":1685753465000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Management of pharmacovigilance during the\n COVID<\/scp>\n \u201019 pandemic crisis by the safety department of an academic sponsor: Lessons learnt and challenges from the\n EU DisCoVeRy<\/scp>\n clinical trial"],"prefix":"10.1002","volume":"11","author":[{"given":"No\u00e9mie","family":"Mercier","sequence":"first","affiliation":[{"name":"ANRS, Maladies Infectieuses Emergentes Paris France"},{"name":"Institut National de la Sant\u00e9 et de la Recherche M\u00e9dicale, INSERM Paris 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