Cardiovascular Sciences Research Consortium Think Tank: Remote Monitoring for Cardiac Safety in Clinical Trials

Area of Science:

• Cardiovascular sciences
• Digital health technologies
• Clinical trial methodology

Background:

• Remote monitoring technologies enable high-accuracy, granular physiologic parameter tracking.
• Variations in device hardware, data processing, and feedback streams pose challenges for digital health technology integration in studies.
• Ensuring safety and evaluating adverse events requires careful consideration of these technological differences.

Purpose of the Study:

• To discuss regulatory considerations for remote monitoring via digital health technologies.
• To provide a framework for using these technologies in evaluating study safety and adverse events.
• To offer practical recommendations and best practices for implementing digital health technologies in clinical trials.

Main Methods:

• Expert panel think tank collaboration between Cardiovascular Sciences Research Consortium and U.S. Food and Drug Administration.
• White paper development synthesizing scientific, technical, and operational perspectives.
• Review of regulatory considerations and implementation strategies for remote monitoring technologies.

Main Results:

• A framework for the regulatory considerations of remote monitoring technologies in clinical trials.
• Practical recommendations and best practices for scientific, technical, and operational implementation.
• Identification of challenges related to device variability in hardware, data processing, and feedback.

Conclusions:

• Digital health technologies offer significant potential for remote physiologic monitoring in clinical research.
• Standardized frameworks and best practices are crucial for the safe and effective use of these technologies.
• This work provides guidance but does not constitute regulatory guidance.