No webinars are scheduled at this time.
October 16, 2020
Webinar: Implications of the COVID-19 Pandemic on Cardiovascular Issues in Clinical Trials. Remote Monitoring of Cardiac Safety: Practical and Regulatory Issues
Moderated by Jonathan Selzer, CSRC executive director, co-sponsored by BioTel Research
Featuring experts from the FDA and industry:
- Stephen Browning, USPHS, Assistant Director, Blood Pressure and Flow Devices, CDRH, FDA
- Kenneth G. Faulkner, PhD, Vice President, eCOA Scientific Services, eRT
- Elektra Papadopoulos, MD, MPH, Acting Director Division of Clinical Outcome Assessment, Office of New Drugs, CDER, FDA
- Fred Senatore, MD, PhD, FACC, Medical Officer/Clinical Team Leader, Division of Cardiology & Nephrology, CDER, FDA
- Kenneth Stein, MD, FACC, FHRS, Senior Vice President & Chief Medical Officer Cardiac Rhythm Management and Global Health Policy, Boston Scientific
- Polina Voloshko, MD, Chief Medical Officer, BioTel Research
In this hour-long CSRC webinar, FDA representatives from CDER and CDRH joined industry experts in research and cardiac safety to discuss current guidance for cardiac safety monitoring in clinical trials, as well as strategies to maintain the integrity of clinical trial research during the COVID-19 pandemic.
This webinar was held on October 16. The full recording is available here.
June 16, 2020
Implications of the COVID Pandemic on Cardiovascular Issues in Clinical Trials: Focus on Biomarkers
Preston M. Dunnmon, MD, MBA, FACP, FACC Acting Medical Team Leader, Division of Cardiology and Nephrology, Center for Drug Evaluation and Research
Andrew Farb, MD
Chief Medical Officer, Office of Cardiovascular Devices (OHT-2), Center for Devices and Radiological Health,
US Food and Drug Administration
|Kristin Newby, MD Professor of Medicine, Co-Director of the Cardiac Care Unit, Duke University Medical Center||James L. Januzzi Jr, MD Hutter Family Professor of Medicine, Harvard Medical School, Cardiology Division, Massachusetts General Hospital, Clinical Trial Design, Baim Institute for Clinical Research|
Moderator: Jonathan Seltzer, MD, MBA, FACC, Chief Scientific Officer, WCG Clinical, President, WCG-ACI Clinical, Director, Cardiac Safety Research Consortium
- 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.
Watch Webinar: Technical Specifications for Submitting Data for QT Studies
- Assessment of the drug effect in QT interval (and other ECG intervals) in dedicated thorough QT and early phase clinical studies and challenges with how data are currently submitted
- Overview of the QT Studies Technical Specifications Document
- Formatting study data for crossover, parallel and other study designs common in QT assessment using the QT Studies Technical Specifications Document
- Standardized analysis using datasets formatted following the QT Studies Technical Specifications Document
- Distinguish the main components of the QT Studies Technical Specifications Document (TSD) for datasets from QT/ECG studies and their relationship with how data are currently submitted
- Create QT Studies TSD compliant datasets from the study raw data sources (e.g., from SDTM to ADSL, ADPC, and ADEG)
- Demonstrate how to use datasets following the QT Studies TSD to perform by-time, concentration-QT and categorical outlier analyses in accordance with the ICH E14 guideline