The COVID-19 pandemic: a catalyst to improve clinical trials
- PMID: 32873977
- PMCID: PMC7461742
- DOI: 10.1038/s41569-020-00439-7
The COVID-19 pandemic: a catalyst to improve clinical trials
Abstract
The COVID-19 pandemic has provided the vital stepping stones to improve how clinical trials are conducted. We provide an overview of the major changes to the clinical trial process instigated by the pandemic and suggest ways to make these changes sustainable.
Conflict of interest statement
D.L.B. discloses the following relationships. Advisory Board: Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Level Ex, Medscape Cardiology, PhaseBio, PLx Pharma, Regado Biosciences. Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft. Chair: AHA Quality Oversight Committee. Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute. Honoraria: ACC (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief,
References
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- FDA. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency https://www.fda.gov/media/136238/download (2020).
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