Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials
In this thought leadership piece for CenterWatch Weekly, Jonathan Seltzer, executive director of the Cardiac Safety Research Consortium (CSRC), a partnership of industry, government and academic leaders, discusses the use of remote patient monitoring in cardiac clinical trials.
During the time when COVID-19 safety protocols were widely enforced, the use of remote patient monitoring in clinical trials exploded. Suddenly, thousands of trials began using remote monitoring, especially in decentralized clinical trials. From wearable devices that track heart rate and rhythm to smartphone apps capable of transmitting real-time data to researchers, the potential benefits of their use in cardiac clinical trials are vast. These devices offer advantages including increased patient participation and retention, reduced travel burdens and enhanced data accuracy and quality.
That said, our collective knowledge and understanding of disease has historically been recorded in still moments, such as test results and patient check-ins. Remote monitoring provides us instead with a 3-D movie reel of information, representing a paradigm shift in the way we interpret data and manage its volume. In fact, many experts are seeking ways to explore this transition. Among them is Rosalyn Adigun, clinical reviewer for the FDA Office of New Drugs’ Division of Cardiology and Nephrology, who has great experience with on-site monitoring on the clinical side and is joining others to better explore the promise and limitations of remote monitoring for cardiac safety in clinical trials as part of an upcoming 2024 think tank meeting forum organized by the CSRC.
This transition may also cause a shift in the understanding of disease and disease progression, and, as such, could facilitate the development of new therapies to transform patient care. Further, many experts have pointed to the promise of remote monitoring for making trials more effective and accessible to patients.
But we are still in the infancy of remote device use and regulation. It was only as recently as 2019 when Euan Ashley, associate dean of the Stanford University School of Medicine, who will join Adigun as a presenter at the CSRC think tank, led the first-ever fully digital randomized trial.
To maintain the integrity of trials, ensure patient safety and support the veracity of the data outputs, it’s critical to have proper regulatory guidance and standards, of which there are currently few. Manufacturers running trials will need to understand the regulatory pathways for devices to ensure their use during trials is acceptable and safe. Further, challenges such as data privacy, technology accessibility and data integrity must be overcome. Striking a balance between benefits and challenges is key to the successful implementation of remote patient monitoring strategies.
As a start, regulatory bodies, including the FDA and the European Medicines Agency, have issued guidelines outlining the principles of remote data capture, data integrity and patient safety.
However, more still needs to be addressed and understood as we embrace digital health solutions in trials. It is through continued dialogue and regulatory collaboration, such as the upcoming think tank and others like it, that we will be able to reshape cardiac trials to further improve efficiency, patient-centricity and data-driven excellence. The think tank meeting will result in a manuscript that offers current best thinking on remote monitoring of cardiac safety in clinical trials based on trial, patient and device characteristics.
With the recent possibility of a government shutdown, the CSRC meeting is now expected to be held in February 2024, a spokesperson told CenterWatch Weekly. For more information, click here.
The opinions expressed here are the author’s and do not necessarily represent those of CenterWatch Weekly.