Moving from Onsite Monitoring to Virtual and At-Home Cardiac Monitoring
Over the past several years, the advent of digital technologies has made possible new clinical trials models known as virtual, remote, or decentralized clinical trials. This trend now seems to be accelerating with the pandemic, and the FDA (with their COVID-19 Guidance) does encourage remote monitoring when onsite monitoring is not possible. Many industry leaders find it likely that the movement toward remote cardiac monitoring and remote clinical trial visits will continue well past the current public health emergency.
In this new paradigm, 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. In our recent Webinar: “Remote Cardiac Safety Monitoring for Clinical Trials – Pandemic and Beyond” regulatory and industry leaders share their views on best practices for meeting these challenges.
- Remote Physiologic Parameters during the COVID-19 Pandemic – Ken Stein, MD
Dr. Ken Stein shared some preliminary examples of what has been gleaned from remote physiologic monitoring early on in the pandemic. In the most recent generation of implantable cardiac defibrillators and cardiac resynchronization therapy devices, there is a suite of physiologic parameters that get telemetered to the cloud on a daily basis. These physiologic parameters include: respiratory rate, rapid shallow breathing index, night heart rate, temperature, thoracic impedance, S1 heart sound, S3 heart sound, and activity. Combining this data with predictive analytics may someday help identify COVID-19 in patients before symptom onset.
- Remote Monitoring of Cardiac Safety: Practical and Regulatory Issues – Fred Senatore, MD, PhD
Dr. Fred Senatore addressed the question of what type of data would be accepted by the FDA for regulatory approval. Elements of remote data that facilitate meeting the evidentiary standard for a substantive review include: a well-defined variability of the acquired data with the selected home monitoring equipment, and measurement strategies capable of distinguishing a clinically meaningful treatment effect.
Remote data capture has proven a viable strategy for pivotal trials with endpoints emanating from non-office visits such as exercise capacity, PRO, hemodynamics. That said, challenges impacting quality of evidence may include undefined variability, protocol amendments resulting in measurement of different efficacy variables, and operational threats to assessment of trial adequacy.
- Cardiac Monitoring Medical Device Landscape – LT Stephen Browning, BS
Lieutenant Stephen Browning presented the four types of cardiac monitoring technologies. First there are devices that capture standard physiologic parameters such as: blood pressure, heart rate, and pulse oximetry. Second there are devices that try to reproduce or mimic common clinical trial end points like the 6 minute hall walk. Third there are clinical decision support tools, often worked into the electronic health record, that make recommendations on things such as medication changes. The fourth are novel clinical diagnostic indices/measurements derived through predictive analytics.
Equally as important is the FDA regulatory status of the device you wish to use. Does your device have independent FDA approval or clearance? Are you using it in a way that it’s labeled? Are there any additional validations or considerations that are necessary?
- Remote Cardiac Monitoring in Clinical Trials: Practical Considerations — Polina Voloshko, MD
Dr. Polina Voloshko presented the topic of practical considerations of cardiac monitoring in clinical trials. Digital technologies are transforming the practice of medicine, especially in the field of electrophysiology. The current pandemic has increased the demand for remote trials, leaving many to search for solutions for preserving trial integrity. There are challenges to confront but there are also great opportunities. Devices have evolved capabilities to: record ECGs at a patient’s home, help establish a diagnosis of random palpitation episodes, and provide tools for long term monitoring for arrhythmias. Finally, large trials involving wearable devices are moving from observational studies to looking into outcomes that are highly desired for clinical research.
With continuous ECG monitoring expanding throughout all phases of clinical drug/device development, and interest in ‘high throughput,’ rich data becoming the norm, continuous remote ECG monitoring is becoming a cardiovascular safety imperative.
- Regulatory Landscape for Clinical Outcome Assessment – Elektra Papadopoulos, MD, MPH
Dr. Electra Papadopoulos outlined how the FDA is addressing the impact of digital technologies on clinical outcome assessments and why it’s important. Clinical outcome assessments (COAs) are critically important when assessing clinical benefit and risk evaluation for trials, and in regulatory decision making. Digital health technologies are central to the larger effort to modernize clinical trials, and their use can enable greater patient centricity.
As the pandemic generates greater interest in remote assessment, the FDA has published a guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” where it offers advice to sponsors on what to consider when changing clinical trial protocols to include remote assessments. There are also two additional sets of FDA guidance that will be forthcoming shortly pertaining to: decentralized clinical trials, and use of digital health technologies for remote date acquisition in clinical investigations.
- Considerations for Virtual and Remote Clinical Outcome Assessments – Ken Faulkner, PhD
Dr. Ken Faulkner shared his considerations for virtual and remote clinical outcome assessments. When going virtual, training is critically important, as people are now being asked to conduct clinical trials in a different way. Specifically, appropriate training and tools should focus on: patient reported outcomes, clinician reported outcomes, laboratory procedures and tests, communication procedures, protocol updates, and e-consent tools.
The need to make changes mid-study, as during the pandemic, can jeopardize study power and future statistical analysis. It’s important to be prepared upfront, before database lock, to adequately account for anticipated study variations and adjust for them.
To listen to the full webinar click here.