Monitoring heart health is a core requirement in many clinical trials. The FDA requires ECG monitoring, especially in early-phase and pivotal studies where cardiac risks are more likely to emerge.
Traditionally, patients had to make frequent clinic visits or wear bulky Holter monitors to support cardiac safety monitoring. Today, wearable ECGs allow patients to go about their daily lives while their heart activity is monitored. As decentralized and hybrid trials become more common, the ability to remotely monitor heart activity helps detect issues earlier while reducing the burden on patients.
The FDA and other agencies require that any device used in research produce accurate and secure data that aligns with traditional ECG tools. Wearable ECGs can help researchers meet those expectations more efficiently, as long as the devices are validated, secure, and aligned with regulatory standards.
When evaluating a new drug, especially one that may affect heart function, either directly or as a side effect, the FDA requires sponsors to monitor cardiac activity using ECGs. A key concern is whether the drug prolongs the QT interval, the time it takes the heart’s ventricles to reset between beats. If this interval is too long, it can raise the risk of serious heart rhythm problems.
The FDA aligns with two key ICH guidelines for evaluating cardiac safety:
In 2022, the FDA and ICH issued Q&A guidance encouraging a more integrated approach to assessing QT risk, combining insights from nonclinical (S7B) and clinical (E14) studies.
More broadly, the FDA has supported a shift toward risk-based monitoring strategies that allow sponsors to tailor their monitoring plans based on the drug’s characteristics and supporting data. This flexibility may open the door for newer tools, like wearable ECG patches, but these devices must still meet the same data quality and validation standards as traditional ECG systems.
Sponsors must ensure that cardiac monitoring tools produce accurate and high-quality data, are validated for their intended use, and support regulatory compliance throughout the trial.
While the FDA does not mandate that all ECG devices be 510(k) cleared, sponsors must ensure the technology is validated and described clearly in the trial protocol, including how data will be collected, reviewed, and secured. Systems must also comply with 21 CFR Part 11 to maintain traceability and integrity if the data is managed electronically.
When sponsors choose devices, such as validated wearable ECGs, that already meet these expectations, they reduce the risk of regulatory delays and improve trial execution.
Wearables enable continuous, real-time monitoring, which allows research teams to capture patterns outside the clinic, like QT changes during sleep or physical activity, and spot potential safety concerns earlier. Patients can stay engaged in the study without frequent site visits or invasive monitoring equipment.
Wearables are a natural fit for DCTs and hybrid trials. When participants live far from a study site, wearables allow them to stay connected without extra travel. Sponsors can track heart data remotely, respond quickly to safety signals, and improve overall trial efficiency.
Cardiac safety will always be a critical part of clinical trials. As clinical trials continue to evolve, wearables offer a way to meet rigorous regulatory requirements while improving the participant experience. Learn more about how Vivalink supports cardiac safety monitoring in modern clinical trials.