Best Practices For Remote Cardiac Safety Monitoring: Reviewing The Regulatory Landscape And Data Compliance

The past years have seen advancements in remote monitoring and telemedicine.  The COVID-19 pandemic has accelerated the movement of healthcare from the hospital and outpatient facilities to the home. This decentralization has also affected the conduct of clinical trials; in July of 2020 FDA issued a final FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. This Guidance suggests that, “Sponsors should determine if in-person visits are necessary to fully assure the safety of trial participants,” and, “in making the decision to continue use or administration of the investigational product, the sponsor should consider whether the safety of trial participants can be assured with the implementation of the altered monitoring approach.”

It is likely that the movement toward remote cardiac monitoring and remote clinical trial visits will continue well past the current public health emergency. As such, it’s essential that clinical trial investigators can confidently monitor patient safety and sponsors have confidence that regulators will accept data that is gathered in a remote format. Therefore, the Cardiovascular Safety Research Consortium (CSRC) has brought together industry experts along with representatives from FDA — from both Centers of Drug and Device Evaluation —  in order to explore some best practices for remote cardiac monitoring.

This Cardiac Safety Research Consortium webinar will be moderated by CSRC Executive Director, Jonathan Seltzer, MD, FACC and is sponsored by BioTel Research. The agenda features regulatory and industry experts:

• Use of Remote Captured Data to Assess Cardiac Safety – Fred Senatore, MD, PhD, FACC, Medical Officer/Clinical Team Leader, Division of Cardiology & Nephrology, CDER, FDA
• Cardiac Monitoring Medical Device Landscape— LT Stephen Browning, BS, Assistant Division Director – Blood Pressure and Flow Devices, Division of Cardiac Electrophysiology, Diagnostics and Monitoring, CDRH, FDA
• Practical Aspects of Remote Cardiac Safety Monitoring—Polina Voloshko, MD Chief Medical Officer, BioTel Research
• Case Study:  Remote Physiologic Parameters during the COVID-19 Pandemic—Ken Stein, MD, Senior Vice President, Chief Medical Officer for Rhythm Management and Global Health Policy, Boston Scientific
• Regulatory Landscape for Clinical Outcome Assessment— Elektra Papadopoulos, MD, MPH, Acting Director, Division of Clinical Outcome Assessment, Office of New Drugs, CDER, FDA
• Considerations for Remote Capture of Clinical Outcome Assessments – Ken Faulkner, PhD, Vice President, eCOA Scientific Services, ERT