Jeff Daurity

	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.

Mobile Health in Clinical Trials Survey Report

, 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:

		35 percent of respondents believe improved data quality to be the biggest benefit of mHealth, followed by improved patient engagement.

		84.3 percent of respondents found that mHealth would be most useful in cardiovascular or cardiac safety studies.

		79 percent of respondents said that of the available mHealth technologies, disease-specific wireless health monitoring would be the most effective use of mHealth technology in a clinical trial.

		Of the major challenges mHealth poses, security, cost and data validation ranked the highest.

		Interestingly, respondents were split between who should be responsible for regulating the use of mHealth technologies, with 42 percent saying it should fall to the U.S. Food & Drug Administration (FDA) while 39 percent agreed that industry should be responsible.

	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.”

	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:

		Equipping patients with tablets and iPads in an effort to capture patient health data at home.

		Using mobile technology for post-surgery monitoring and quality-of-life surveys that could now take place at home versus onsite.

		Implementing the use of continuous remote monitoring apps to track patient data in real-time and limiting the reliance on patients to collect data points. A great example of this is the use of continuous glucose monitoring.

	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. 

	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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mHealth is making a strong case for its ability to optimize clinical trials and improve engagement with participants and patients.

Jeff Daurity

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