It is nearly impossible today to avoid the growing number of commercially available wearable devices capable of gathering health information. These devices—typically placed on a wrist, arm or chest—hold promise for col­lecting, transmitting and integrating objective experiential data in real time and in aiding the analysis of a much higher volume of data from a significantly larger number of patients. But based on interviews with industry profession­als, the conceptual promise of wearable devices in clinical trials remains largely that. Adoption is in its very earliest stages.

The rate of adoption also will proceed slowly. Wearable devices in clinical trials face signifi­cant hurdles and challenges that must be over­come. Data-rich wearable devices have raised concerns about battery life, data accuracy, data interpretation and patient privacy. Wearable device manufacturers also face FDA approval, HIPAA compliance requirements, the need to standardize data and measurement approach­es, and the requirement to establish compat­ibility and interoperability with existing data management systems.

Wearable device types, for example, have varying levels of accuracy depending on what is measured. “Wrist-based devices are not as accurate in measuring ECG and heart outputs, because the wrist is too noisy with the moving and twisting, which makes it hard to pull in and distinguish wave forms. Chest-based de­vices have a clearer signal and the data is more accurately captured,” said Eric Selvik, vice pres­ident of strategic marketing at Vital Connect.

No matter which type of device is used, transforming activity-based data into mean­ingful medical outcomes for patients will re­quire collaboration between regulators and industry. Activity monitors also stream data without structured procedures compared to that of traditional medical devices such as spirometers and heart assessment monitors. And interpreting wearable device data raises concerns over how to evaluate and identify pa­tient-reported outcome data that is pertinent to include with clinical outcomes data. Wearable devices also provide new sources of data re­quiring the industry to address interoperability and data interchange issues.

“Understanding the correlations between traditional endpoints and how data from wearables correlate to those endpoints has yet to be defined,” said Nicholas Richards, Par­exel’s vice president, product management. “There is also a lot of noise in the data and I don’t think there is a solid agreement in the industry over how to filter it out. There are processes and recommendations beginning to provide some direction, but we are still at the earliest stages before we see these devices used in clinical trials.”

But solutions proliferate

The emerging healthcare market for wear­able devices has attracted a growing mix of established firms and entrepreneurs. In 2015, nearly 35 million wearable devices units for healthcare purposes were sold, nearly triple the volume sold in 2013. The prospect of a potential­ly large market for new devices that can poten­tially shorten clinical trial cycle times and en­gage larger numbers of patients is compelling.

To name but a couple of notable devices:

• Garmin’s vivofit is a water-resistant device designed to be worn on the wrist around the clock. It measures distance, calories burned, hours slept and time of day, and comes with a yearlong battery life.
• HealthPatch MD is a disposable stick-on chest device from Vital Connect used to monitor both acute and chronic diseases. Biometric data and changes in vital signs are wirelessly sent to and monitored by doctors and patients via Bluetooth. The sensor collects continuous clinic-grade data that can be used on a range of health parameters providing heart rate variability, skin temperature, body posture and steps, and has ECG electrodes to detect heart rate. Battery life for the HealthPatch is just two to four days.

“With vivofit, we have a tracker that pro­vides data quality, patient engagement and tri­al operational efficiencies” said Kara Dennis, managing director of mHealth at Medidata. “It also has ease of use and better potential for compliance because it has an excellent battery life. Sponsors are concerned about devices with short battery life where patients have to put it on, take it off, [which] raises questions about why they are wearing it,” she said.

“There’s a lot of support required. We need to make sure that the data is physio­logically appropriate. We also need to make sure that strong processes, algorithms and detection methods are in place, and that the right subject is wearing the device and has not given it to someone else,” added Dennis.

Several major players have entered the market for wearable devices in clinical re­search. The most notable entrant has been Apple’s Research Kit—a smartphone app supporting patient recruitment. For a recent heart disease study, Stanford University was able to recruit 11,000 participants in just 24 hours using Apple’s Research Kit—an ac­complishment that would usually take 50 medical centers an entire year to accomplish by using traditional recruitment approaches. Apple has essentially turned every iPhone into a clinical research technology solution. To date, Apple has developed five Research Kit apps and enrolled more than 60,000 iPhone users in various studies.

Google recently announced that it is de­veloping a new health-tracking wristband that can monitor pulse, heart rhythm, skin temperature, light exposure and noise level. The prescription-only wristband is designed for use in clinical trials and to provide phy­sicians with real-time data about a patient’s activity and vital signs between checkups.

Pilot Projects

“Many major biopharmaceutical companies are taking steps to understand the landscape of available wearable devices and to deter­mine which devices best meet their particular needs within the context of a study,” said Matt Winslow, vice president of innovation at Con­versant Health. “Additionally, companies are reviewing data-privacy implications and devel­oping best practices for working with IRBs on studies using wearable devices.”

In 2014, GlaxoSmithKline and Medidata partnered on a pilot project to evaluate wheth­er mHealth technologies can deliver reliable FDA-compliant data using the HealthPatch MD, a chest-worn device and a wrist monitor device from ActiGraph.

The HealthPatch gathered continuous data—18 million data points per participant per day—on vital signs, activity levels and heart rhythms that were fed into their smartphones. The company’s Clinical Cloud system then col­lated the data and mapped it to the clinical re­cord of the participants.

The disposable HealthPatch, however, had a significant drawback: Its battery life lasted for just two to four days. In a clinical trial setting, the device required changing batter­ies and re-adhering it like a Band Aid on the chest.

“We dealt with that issue as part of our FDA filing,” said Vital Connect’s Selvik. “We conducted a 50-day test on taking the patch off, inserting a new battery and sticking it back on every three days with a group of peo­ple ages 59 to 86, and got 94% compliance. We showed that it was easy and foolproof.” Selvik also acknowledged that the next ver­sion of its disposable chest patch will have a longer battery life.

Earlier this year Novartis announced an alliance with Qualcomm Life, a subsidiary of Qualcomm Inc., to use its cloud-based 2net Platform to collect and aggregate medical-device data during in-home remote monitor­ing of clinical trial participants. Last year, No­vartis launched an observational trial collect­ing biometric data from chronic-lung-disease patients in their homes using smartphones connected to the platform.

In entering this alliance, Novartis noted the promise of automated wearable-device data collection to augment a comprehensive data­base that can then be monitored and analyzed for response and side-effect patterns.

Medidata recently released the results of a pilot using a wearable device in a weight-loss behavioral study involving 20 diabetic and overweight patients to explore the challenges and opportunities associated with the adop­tion of mobile sensors, wearables and mobile apps in clinical trials. Conducted with Miami Research Associates and with local IRB approval, the study captured movement levels and sleep patterns from FitBit activity track­ers and subjective patient-reported diary data collected via smartphones that was securely pulled into the company’s Clinical Cloud platform and integrated with other clinical trial information. Study participants received text-message notifications on nutrition and exercise that were designed to keep patients engaged along with relevant updates from doctors.

Analysis of the data showed that while more than 50% of the participants lost weight, 90% of the participants were compliant in wear­ing their activity trackers. Medidata also was able to identify a number of correlations in the data that could be tested in larger clinical tri­als, such as the relationship between activity and pain, and a connection between vigorous activity and weight loss. The company said it is now using the technology infrastructure for other phase I-IV mHealth clinical trials.

Moving forward

“The important next steps are packaging wearable devices into easy-to-use kits for in­vestigative sites and developing a process for making sure that patients in trials understand what is involved,” said Parexel’s Richards. “That includes making sure patients routinely wear the devices, routinely link to the Internet and, most importantly, really understand ex­pectations and what the clinical trial is trying to achieve.”

“The real test of this new generation of wearables is whether they are reliable, accu­rate enough and easy enough for subjects to use that will reduce the number of concerns and problems that are just starting to get ad­dressed—but this will take time,” added Abraham Gutman, CEO of AG Mednet. “Right now, we are in the first minute of the first inning of advanced wearables.”

Selvik is more optimistic: “The time frame could be accelerated by some very forward-thinking pharmaceutical companies and CROs who see a competitive advantage in quickly implementing wearable devices.”

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 22, Issue 08, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>