How Will mHealth Transform Clinical Trials?

The introduction of easily worn biosensors, such as FitBit, Garmin’s Vivofit, and Apple’s iWatch, have created a large influx of interest in the area of mobile health (mHealth).   While these technologies are quite premature, the concept of interventional health regulation through biosensors and mobile applications is breakthrough, consumers grasping on very rapidly, and the market is exploding with new products.  Soon enough, these technologies will be applied in clinical trials.

mHealth: Generating Massive Interest in the Way Patients Manage Health

Research conducted by The Economist Intelligence Unit found that 48% of patients felt that mHealth will significantly change the way they manage chronic conditions, 47% felt that mHealth will change the way they measure and share vitals, and 59% felt that mHealth will change the way they seek information on health issues ^[1].  Moreover, the opportunity for global mHealth adaptability is widespread and accessible; for example, in 2010, nearly 88% of the US population and roughly 61% of the Chinese population subscribes to a mobile phone service ^{[1, 2]}.

New Generation Activity Trackers are Penetrating the Market

mHealth products, such as Spire and Lumo Lift incorporate easily worn biosensors with mobile app and gamification elements to coach and intervene with peoples’ health behaviors.

Spire, for example, is capable of tracking respiration, activity, and stress levels, and coaches people to become active, in order to reduce their stress levels through respiration control and physical exercise.  Lumo Lift is more limited than Spire, but, tracks posture, and activity; the device coaches people to improve their posture through vibrations and app notifications.  Naturally, these applications track and quantify performance over time.

FDA Regulated Mobile Medical Applications: Beyond Arm’s Reach

In February 2015, the FDA updated its guidance for mobile medical applications ^[3].  In its guidance, the FDA does not classify mobile apps as medical devices, and chooses to exercise its discretion on whichever device they choose in order to maintain appropriate patient safety. 

Rather than focusing on the device and software itself, the FDA is pursuing enterprises that make unapproved medical claims in their marketing and advertising materials.  Though there aren’t notable incidences of FDA warning letters in mHealth, in 2013, the FDA issued a warning letter to Google-backed 23andMe, a consumer-based DNA sampling and analysis service.  In this letter, the FDA expressed concerns regarding 23andMe’s advertising claims surrounding health reporting, drug response, and mitigating serious diseases ^[4].  While both Spire and Lumo Lift are considering obtaining 510 (k) approval ^{[5, 6]}, the pace of the technology industry will continue to influence and push the FDA to efficiently oversee and regulate mHealth.

mHealth for Interventional Use in Clinical Trials: Still Premature

The biopharmaceutical industry has taken some risks in experimenting with biosensors in clinical trials, however, the industry has some ways to go before mHealth becomes mainstream in clinical trials. At the 2014 DIA annual conference, Genentech and Quintiles presented results from an observational study comparing patient reported outcomes (eDiaries) with biosensors ^[7], and results suggested an improvement in the frequency and quality of clinical trial data with potential for many clinical trial opportunities.

More recently, Medidata completed the MOVE-2014 study, which evaluated lifestyle modifications on 23 Type II diabetes patients ^[8], in order to demonstrate that mHealth can be used in clinical trial settings to generate a holistic view of disease progression data collection and outcomes ^[9].

What are the benefits of mHealth in Clinical Trials?

mHealth offers numerous benefits in clinical trials including collecting higher frequency data, enhanced data quality, behavioral modification, enrollment, and patient adherence to name a few.  The biggest benefit that mHealth offers includes convenience and compatibility in patients’ lifestyles during clinical trials.

What Advances Will we see in mHealth for Clinical Trial Usage?

Once we start seeing several FDA approved and validated mHealth technologies in the healthcare space, and the mHealth market saturates, we will likely observe mHealth penetration in the clinical trials industry.  Albeit mHealth technologies are readily available to be used in clinical research, the need for behavioral change in clinical operations personnel and the lack of mHealth technology validation are creating barriers to entry.

Nonetheless, the potential for mHealth use in clinical trials is tremendous. For example, Apple’s iWatch and Research Kit is opening avenues for efficient and highly optimized subject enrollment (in one study, enrolling more than 10,000 qualified subjects overnight ^[10]), and with Apple’s iOS developer platform, we’re going to see many different mHealth applications that can be used on one device.  Moreover, advances in measurement technologies, such as silicon based microneedles, may be incorporated in mHealth devices to obtain interstitial fluid readings ^[11], which will expand access to collecting data on a broader spectrum of vitals.  These mHealth devices mark the start of a big era that will transform clinical trials.

References:

[1] https://www.pwc.com/gx/en/healthcare/mhealth/assets/pwc-emerging-mhealth-full.pdf

[2] https://www.google.com/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=china+population+2010

[3] http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf

[4] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm

[5] http://techcrunch.com/2014/06/17/spire-breath-taker/

[6] http://mobihealthnews.com/28419/lumo-to-crowdfund-lift-a-smaller-more-wearable-posture-tracker/

[7] http://www.appliedclinicaltrialsonline.com/highlights-2014-dia-annual-meeting-san-diego

[8] https://clinicaltrials.gov/ct2/show/NCT02227303?term=medidata&rank=1

[9] https://www.mdsol.com/en/newsroom/press-release/medidata-completes-study-exploring-potential-instrumenting-patients-mobile

[10] http://appleinsider.com/articles/15/03/11/over-10k-participants-sign-up-for-stanford-medical-trial-after-researchkit-debut

[11] https://www.tyndall.ie/content/microneedle-technology