Join us Tuesday, June 16th at 2:00 pm ET for a webinar focused on the implications of the COVID pandemic on cardiovascular issues in clinical trials. The webinar will provide rigorous, transparent discussion of current best practices for conducting clinical trials in the COVID era. Attendees will have a unique opportunity to hear from a multi-stakeholder panel of FDA representatives and researchers on the implications of the pandemic on cardiovascular issues in clinical trials with a focus on biomarkers.
In this webinar, our experts will discuss:
- FDA guidance on COVID clinical trials and the implications of cardiovascular issues.
- The strengths and weakness of recently reviewed COVID protocols and decipher what the FDA might expect regarding COVID status in study subjects, potential cardiac involvement as well as data analysis plan modifications.
- Cardiovascular biomarkers required for collection in the evaluation of cardiovascular adverse events.
- Cardiovascular biomarker profiles which should be collected upon entry in clinical trials for the evaluation of cardiovascular risk.
Join a conversation with renowned experts to discuss leading-edge perspectives:
- Dr. Preston M. Dunnmon, MBA, FACP, FACC, Acting Medical Team Leader, Division of Cardiology and Nephrology, Center for Drug Evaluation and Research
- Dr. Andrew Farb, Chief Medical Officer, Office of Cardiovascular Devices (OHT-2), Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration
- Dr. Kristin Newby, Professor of Medicine, Co-Director of the Cardiac Care Unit, Duke University Medical Center.
- Dr. James L. Januzzi, Jr., Hutter Family Professor of Medicine, Harvard Medical School; Cardiology Division, Massachusetts General Hospital; Clinical Trial Design, Baim Institute for Clinical Research
- Dr. Jonathan Seltzer, MBA, FACC, Chief Scientific Officer, WCG; President and Founder, WCG ACI Clinical; Director, Cardiac Safety Research Consortium