Royal Philips has announced the introduction of a full-service, at-home, 12-lead electrocardiogram (ECG) solution for use in decentralised clinical trials. The clinical-grade solution is the most advanced patient-centric ECG offering within the company’s cardiac monitoring portfolio, pairing data readings comparable to clinical, site-based ECGs with Philips’ cloud-based data collection and analysis services.
This latest addition to Philips’ digitally enabled suite of monitoring solutions helps to drive innovation across the care continuum and support the decentralised clinical trial space.
Patient attrition is one of the biggest issues faced by clinical trial sponsors seeking regulatory approval for new therapies, Philips said in a press release. Attrition over the course of a study can reduce the quality of its findings and can lead to longer, more expensive trials that require higher than optimal recruiting rates to compensate. Voluntary patient withdrawal is often tied to disease progression or the prolonged inconvenience of adhering to protocol regimens and repetitive site visits. By offering the consistent and reliable standards of a 12-lead ECG in the comfort and convenience of a patient’s home, Philips at-home ECG solution aims to improve trial recruitment, compliance and patient retention by reducing the need for and burden of site visits, the company said.
“Our customers are seeking solutions that will help them to address key challenges that can stand in the way of extracting meaningful insights from their clinical trials,” said Andy Broadway, general manager of Ambulatory Monitoring and Diagnostics at Philips. “Our growing portfolio of remote monitoring solutions help to curb patient attrition by reducing the amount of site visits required during the trial period, helping to improve both the quality of the outcome and the patient experience overall.”
Leveraging PCA 500 ECG patch data recording technology, the at-home solution allows clinical trial participants to record data with quality comparable to site-based ECGs at home. The solution’s innovative body-worn patch ensures compliant 12-lead ECG placement and near real-time, highly secure data transmission without the need for recurring site visits, onsite technician, or home nurses.
Philips offers a complete range of clinically validated ambulatory cardiac diagnostics and monitoring services and associated expertise to its cardiac care portfolio, including its BioTel Research capabilities that have already supported more than 2,000 clinical trials in 72 countries.