According to a report by Rock Health, 80% of consumers adopted at least one digital technology in 2015, after $4.3bn was invested in digital health funding – and although many of the consumer-grade wearables, such as the Fitbit, have limitations in clinical research programs, they can provide a wealth of exploratory endpoint data.
“Everyone is releasing a wearable … even companies you wouldn’t think of,” John Reites, Quintiles head of digital health acceleration, told us while attending CES earlier this year, and many of these companies are looking to get FDA approval.
Additionally, already established Class II wearable and devices are continuing to improve and become more user friendly, with better interoperability, so they can be intergraded in clinical research programs.
“Digital health isn’t a new conversation,” he adds. “I think the perception is starting to shift and people are starting to ask more complex and detailed questions.”
The moving train
As part of his job, Reites helps people understand how digital health technologies could augment a study; however, he also spends a lot of time with customers explaining what they can’t do.
For the CRO looking to invest in digital health technology, the magic word is integration.
“We have to remember in clinical trial – phase 1 to phase IV – a wearable or an app is just a piece of the story … it’s just a component of how you collect data,” he explains.
And there are several options for collecting data, all of which must be put into the overall framework of a clinical research study, and in a way “so [the technology] doesn’t get in the way of what the investigators or patients are trying to do,” says Reites.
Part of this means working closely with privacy experts, “It’s a wealth of regulation,” explains Reites.
“Each time you introduce any new thing … we have to vet it through a process. It’s a moving train that you have to keep up with.” He adds. “It’s not as easy as ‘grab a device and put it on people.’”
In addition to improved data collection, digital health technologies have proven to increase patient engagement. This is a benefit that Reites thinks his customers are going to get more intrigued about as they try to be more patient centric. However, there are still a lot of questions to be answered.
“If you choose to use a wearable, how will it work and how will it be operationalized?” asks Reites. “We’ve made a lot of successful mistakes along the way.”
Progression and practicality
The healthcare market continually balances moving quickly and allowing the market time to embrace change. “Digital health is moving so fast,” says Reites, “so, you have to be fast like a tech company.”
For Quintiles, this means using an internal accelerator programs to test new technologies.
Ultimately, “We have to balance really cool, progressive ideas, with practicality,” says Reites. “There are still a lot of barriers. [The technology] has to be practical and fit for a purpose … The last thing we want to do is use wearables because they’re cool; we want to use them because they affect the study the right way and provide outcomes.”