Royal Philips has unveiled a full-service, at-home, 12-lead electrocardiogram (ECG) solution for use in decentralized clinical trials. The patient-centric ECG offering pairs data readings comparable to clinical, site-based ECGs with Philips’ cloud-based data collection and analysis services.
Patient attrition is one of the biggest issues faced by clinical trial sponsors seeking regulatory approval for new therapies. 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. With that, Philips at-home, 12-lead ECG solution aims to improve trial recruitment, compliance, and patient retention by reducing the need for and burden of site visits.
“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,” says 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.
The at-home, 12-lead ECG solution is now available in select markets across North America, Europe and Asia.
 Hui D, Glitza I, Chisholm G, Yennu S, Bruera E. Attrition rates, reasons, and predictive factors in supportive care and palliative oncology clinical trials. Cancer. 2013;119(5):1098-1105. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3568443/
Featured image: Philips introduces first at-home, 12 lead ECG integrated solution for decentralized clinical trials. (Royal Philips)