Signant Health, formerly CRF Health and Bracket, has announced an integrated of its eCOA platform TrialMax, with ActiGraph’s CentrePoint system. The integration, which includes ActiGraph’s FDA 510(k) cleared sensors, helps simplify the process of collecting and monitoring real-world activity, mobility, and sleep outcomes data for patients and researchers.
The TrialMax and CentrePoint system integration is yet another step pointing towards the growing importance of measuring real-world patient function in clinical trials. Home-based activity and sleep monitoring, measured using ActiGraph’s research-grade wearable devices, provides important insights into real-world functioning that are applicable to drug development in a broad range of disease indications. Many diseases adversely affect activity and sleep, which ultimately impacts quality of life. Measuring treatment-related improvements in free-living activity and sleep provides valuable and objective insight into the aspect of treatment, and is essential in the study of sleep disorders, and also a critical component used to assess patient quality of life in many other conditions including pain, asthma, COPD, overactive bladder, cancer, and others.
The integration provides important efficiencies and simplifies workflow for study sites. Patients are enrolled using Signant Health’s TrialMax eCOA platform, and real-time integration with ActiGraph’s CentrePoint platform means that all enrolment activities are accomplished through the single TrialMax interface. Sites and Sponsors can also view activity and sleep parameters alongside patient-reported outcomes data collected via TrialMax through Signant Health’s online reporting solution. In addition, data-driven notifications and alerts can be triggered based on both the activity/sleep and eCOA data collected using TrialMax – for example, providing reminders to patients to encourage compliance if they have worn the ActiGraph device for less than the requested number of hours per day.
Bill Byrom, Signant Health’s VP Product Strategy & Innovation, said “It’s important that patients continue to experience trials that benefit them without burdening them. Using ActiGraph’s devices not only provides a simple and efficient experience for patients, it also simplifies and streamlines trials for sites and sponsors while offering better data and insights.”
Byrom added “It’s also beneficial for compliance. The combination of ActiGraph’s activity and sleep monitoring with TrialMax eCOA enables proactive data-driven alerts and notifications to sites and patients. We believe this has the potential to reduce unusable data and improve data quality when measuring real-world activity and sleep alongside patient-reported outcomes in clinical trials”.