SARS-CoV-2 disrupts clinical research: the role of a rare disease-specific trial network
- PMID: 32764115
- PMCID: PMC7411273
- DOI: 10.1183/13993003.02114-2020
SARS-CoV-2 disrupts clinical research: the role of a rare disease-specific trial network
Abstract
Rare disease patients may suffer delayed access to new drugs as SARS-CoV-2 is disrupting clinical trials. This survey demonstrates that the European Cystic Fibrosis Clinical Trials Network is ideally placed to track and address such disruption.
Conflict of interest statement
Conflict of interest: S. van Koningsbruggen-Rietschel reports grants from Algipharma (HORIZON2020), personal fees from Deutsches Zentrum für Infektionsforschung, Antabio, Proteostasis Therapeutics, Roche and Vertex Pharmaceuticals, outside the submitted work. Conflict of interest: F. Dunlevy has nothing to disclose. Conflict of interest: V. Bulteel has nothing to disclose. Conflict of interest: D.G. Downey reports grants and personal fees from Vertex, Proteostasis and Chiesi, outside the submitted work. Conflict of interest: L. Dupont has nothing to disclose.
Comment on
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Preserving Clinical Trial Integrity During the Coronavirus Pandemic.JAMA. 2020 Jun 2;323(21):2135-2136. doi: 10.1001/jama.2020.4689. JAMA. 2020. PMID: 32211830 No abstract available.
References
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- McDermott MM, Newman AB. Preserving clinical trial integrity during the coronavirus pandemic. JAMA 2020; 323: 2135–2136. - PubMed
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- Food and Drug Administration . FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. www.fda.gov/media/136238/downloadDate last updated: 14 May 2020. Date last accessed: 15 May 2020.
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- European Medicines Agency . Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic. www.ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanc...Date last updated: 28 April 2020. Date last accessed: 15 May 2020.
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