Clinical trials and today's technology: Wearables

The challenges of clinical trials start with their recruitment difficulties, proceed through their regulatory restrictions and end with their high rate of drop-outs, even after all else seems to be falling into place.

Fortunately, improvements in mobile health (mHealth) technology such as mobile phones, patient monitoring devices, tablets, smart phone apps and other wireless devices are making inroads into all those issues.  

One category slated to help trial participants better stay on track with their health metrics is that of wearable HealthTech gadgetry such as FitBits and smartwatches. That segment as a whole is slated to be worth $25 billion by 2019, and major technology companies are hard at work on medical-grade wearables geared toward trialists and similarly targeted patients. Still, actual usage is still in the infancy stage; a Gartner study last year predicts fewer than 10 percent of clinical trials next year will take advantage.

Product examples cited this year by Niklas Morton on Appliedclinicaltrialsonline.com include recently released or in-development products like Apple’s biometric headphone system that allows the wearer to listen to music; A Google wristband that measures pulse, heart rhythm, skin temperature, light exposure and noise levels; and the Apple ResearchKit software platform that enables created apps for the measurement of wearable-harvested trial data. The ResearchKit essentially turns smartphones into research tools, allowing medical researchers worldwide to contribute new research modules to its open source framework. It’s also proven extremely helpful for recruitment, and was recently optimized to find and sign up 11,000 participants for a Stanford University heart disease study — in an unprecedented 24 hours.

Analysts expect top outcomes of such innovations to include easier recruitment; more accurate health profiles encompassing a larger multitude of real-time measurements; easier comparison of time-marked data; better retention of subjects via reminders, info sharing and positive messaging; and reduced costs as in-person monitoring becomes less necessary. But certain barriers exist as well, including data security and privacy; data qualification and validation; regulatory acceptance; adoption costs; proof of ROI and global adoption. Data qualification and validation are another issue, cautions Thad Wolfam on MDsol.com.

“With (wearables) comes non-controlled research environments and the need to address patient devices use and adherence variability,” he writes.

Other specific ways wearable devices are advancing clinical trials include:

  • They can monitor respiration, oxygen saturation, ECG, blood pressure, skin and core temperature and galvanic skin response, then transmit results directly to researchers, supporting patient care in most therapeutic areas including gerontology and chronic disease.
  • Ingestible monitors can collect data on medication ingestion, dose timing and physiologic responses, and then transmit measurements via smartphone, according to Morton.
  • Electronic patient-reported outcome (ePRO) companies are adding multi-device capacities, such that one offers ePRO software for mobile devices with apps on Android, Windows 8 and iOS and another enables a bring-your-own-device program for trialists.

Overall, such remote patient-monitoring technologies are expected save the U.S. healthcare system $200 billion by 2040, analysts predict.  

“During the next five years, mHealth technologies will mature to enable advanced research models, including cloud-based health databases of continuously uploaded patient data and internet-based trials conducted remotely,” Morton predicts. “The immediate challenge is to integrate mHealth technologies into global research processes, and to learn how best to apply and interpret the data tsunami they are about to deliver.”