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mHealth is making a strong case for its ability to optimize clinical trials and improve engagement with participants and patients.
The use of mobile and wearable health (mHealth) technologies has garnered significant attention recently. From the launch of Apple’s ResearchKit in March to Medtronic’s recent approval for the first remote monitoring app for implantable pacemakers, mHealth is making a strong case for its ability to optimize clinical trials and improve engagement with participants and patients.
Last week, digital health technologies took center stage at the 2016 International Consumer Electronics Show, which took place in Las Vegas, January 6-9. While the majority of the products unveiled during the Digital Health Summit supported more consumer-centric applications, privacy, data and analytics and how new digital technologies offer new insight into health patterns and future outcomes were also featured. The role of data and privacy will play an important role in determining how to best integrate the digital health revolution into actionable clinical use.
According to the Mobile Health in Clinical Trials Survey Report from SCORR Marketing and Applied Clinical Trials, while 80 percent of respondents believe the industry’s use of mHealth technology is still in its infancy, 60 percent consider it to be very or extremely important.
A few other key takeaways from the Mobile Health in Clinical Trials survey include:
mHealth and Cardiovascular Studies
The assumption that cardiovascular studies would be best served by mHealth technologies holds merit given the majority of the technologies currently in use are devices that support the assessment of cardiovascular health. These include everything from blood pressure and glucose monitors, to mini EKG devices, defibrillators and pedometers. Medtronic’s new MyCareLink Smart Monitor even connects implantable pacemakers with a patient’s own smartphone or tablet, which, according to the company, “provides patients with a more intuitive platform to communicate with their caregivers, improve their standard of care, and reduce healthcare costs.”
Appropriate Clinical Trial Settings
Consensus shows mHealth can be most useful when it comes to improving data quality and patient trial adherence. How does a sponsor go about implementing possible mHealth technologies in their trial? Examples include:
While mHealth holds promise in changing the way clinical trials are performed, developers and regulators must address several challenges before this technology can be fully adopted. Such challenges include security, technology and patient compliance/data integrity. For example, if an app is poorly designed or hard to use, it may generate misleading data.
Benefits for Short-Term Studies
Given the number of challenges that still remain, mHealth in its present state works better for short-term studies where the patient only needs the device for a brief, defined period of time. For larger, longer-term cardiovascular studies, such as those studying vascular stents, mHealth technologies may not prove to be as beneficial because the patient only requires check-ups at six months post-surgery and then once/year for the next five years.
mHealth holds a lot of promise when it comes to optimizing clinical trials. Once developers can overcome some of the challenges preventing wide-scale adoption, it won’t be long before it plays an integral role in clinical trial management.
Jeff Daurity is Associate Director, Medical Device & Diagnostics, Cardiovascular Therapies at Novella Clinical.
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