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

TL;DR

This paper discusses how remote monitoring technologies can improve cardiac safety in clinical trials through better data tracking and regulatory frameworks.

Contribution

The paper provides a framework and best practices for using remote monitoring in clinical trials through a public-private partnership.

Findings

Remote monitoring can reduce study overhead and improve access to care.

Digital health technologies should be anchored to known endpoints and usability principles.

Private-public partnerships may uncover early safety signals and improve patient outcomes.

Abstract

Recent advances in remote monitoring technologies have empowered continuous tracking of physiologic parameters with high accuracy and granularity. However, there are important differences in the hardware, data processing, and feedback streams of individual devices which can impact the use of digital health technologies when evaluating safety in studies. This expert panel is the result of a think tank through a public–private partnership of the Cardiovascular Sciences Research Consortium and the U.S. Food and Drug Administration. The white paper discusses regulatory considerations for remote monitoring through digital health technologies to provide a framework for their use when evaluating safety or adverse events. It also provides practical recommendations and best practices on the implementation of these technologies into clinical trials through a scientific, technical, and operational lens. This manuscript does not constitute regulatory guidance.

•Remote monitoring is becoming key to clinical trial design with the potential to reduce study overhead, improve access to care, and uncover novel data signals.•Individual digital health technologies can vary, and are most effectively employed by anchoring to known endpoints, defining usability principles, and setting clinical guardrails.•Large-scale private-public partnerships to redefine a “remote” physiologic baseline and cardiac events may uncover early safety signals and improve patient outcomes.

Remote monitoring is becoming key to clinical trial design with the potential to reduce study overhead, improve access to care, and uncover novel data signals.

Individual digital health technologies can vary, and are most effectively employed by anchoring to known endpoints, defining usability principles, and setting clinical guardrails.

Large-scale private-public partnerships to redefine a “remote” physiologic baseline and cardiac events may uncover early safety signals and improve patient outcomes.

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