Immediate and long-term impact of the COVID-19 pandemic on cardiovascular clinical trials: considerations for study conduct and endpoint determination

EuroIntervention 2020;16:787-793. DOI: 10.4244/EIJV16I10A147

Alexandra  J. Lansky
Alexandra Lansky1,2, MD; Tayyab Shah1, MD; William Wijns3, MD; Giulio G. Stefanini4, MD, PhD; Andrew Farb5, MD; Aaron Kaplan6, MD; Bo Xu7, MD; Cody Pietras1, BS; Eric Velazquez1, MD; Patrick W. Serruys3, MD; Felix Mahfoud8,9, MD; Andreas Baumbach1,2, MD
1. Yale University School of Medicine, New Haven, CT, USA; 2. Barts Heart Centre, London and Queen Mary University of London, London, United Kingdom; 3. The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, and Saolta University Healthcare Group, University College Hospital Galway, Galway, Ireland; 4. Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy; 5. Center for Devices and Radiological Health, Food and Drug Administration, Gaithersburg, MD, USA; 6. Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA; 7. Fu Wai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences, National Clinical Research Centre for Cardiovascular Diseases, Beijing, China; 8. Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Homburg (Saar), Germany; 9. Institute for Medical Engineering and Science, MIT, Cambridge, MA, USA


The current COVID-19 pandemic caused by SARS-CoV-2 began in November 2019 in Wuhan, China1, and has caused a global healthcare crisis with more than twenty million confirmed cases and almost 800,000 deaths as of 16 August 2020. The resulting burden on medical systems and the imposed social distancing measures in countries around the world have disrupted economies, healthcare systems, and ongoing clinical trials. Challenges have arisen due to quarantines and SARS-CoV-2 infections of hospital personnel and subjects, in-person follow-up appointment cancellations with a rapid shift to telemedicine, travel restrictions, supply chain disruptions of investigational products, cancellation of non-urgent procedures, and prioritisation ...

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