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