Quintiles uses Solution Design Studio in journey to integrate digital tech with clinical trials

Smart phones aren’t just for playing hours-long games of Pokemon Go. Along with fitness trackers, smart watches, and virtual reality headsets, the newest digital tools are the latest pieces of health tech the pharmaceutical industry is looking to as a way to lower costs during clinical trials. Now Quintiles, the largest contract research organization in the world, is racing headlong into this new world with the opening of its Solution Design Studio.

As CEO Thomas Pike explained during the company’s second quarter earnings call, the Solution Design Studio is “where expert teams will collaborate to create technology solutions to tackle some of healthcare’s biggest challenges.” That might mean vetting and simulating the potential uses of new technologies, like the Samsung Gear virtual reality headset, in a clinical testing environment, or designing and programming early versions of mobile apps. The crux of it all is to explore how digital health tools can be used in real clinical trials, not just simulations or pilot studies. According to Quintiles, a world where remote monitoring technology used in tandem with other digital health tools in real clinical trials is right around the corner.

“I probably can’t go into details for specific customers, but we’re really close,” said Shelby Burdick, global head of the Solution Design Studio, in a phone interview.

The Solution Design Studio opened May 17 at the company’s campus in Research Triangle Park in North Carolina, although Quintiles has had an internal team of developers and health IT experts working on digital health questions for almost six years. So far in 2016, the team’s been involved in more than 60 health tech projects, with more on the way and several pilots already in motion at the new studio.

“Among the projects under consideration are pilot projects using an eDiary mobile solution for patients, which may include native reminder functionality, user interfaces with simple one-touch responses to diary questions, and integrations with different wearable devices that capture patient data,” Burdick said.

Part experimental lab, part technology accelerator, the studio is kitted out with the usual stuff one might find at an early stage tech startup: enough computers for the developers to code away on apps, ample workspace, new gadgets such as the Google Glass and several pairs of Gear VR headsets.

Using digital health technology in clinical trials is of huge interest to the pharmaceutical industry. Many of these trials take place outside of the U.S. at various sites, which means the principal investigator has to travel to multiple locations, and recruiting patients for trials can be a long process. Both are factors that drive up cost. But if remote monitoring tools like wearable health trackers, smart watches, video conferencing, and smart phone apps could be used, the cost of clinical trials might be significantly reduced.

For instance, suppose patients were equipped with a mobile app to enter diary-type responses about how a clinical trial is going instead of relying on logging information by hand on pieces of paper. If a wearable device were also integrated, information on patients’ health could be transmitted in real-time, augmenting the written responses from patients or even replacing them entirely.

“That’s a real project the Solution Design Studio is doing right now,” Burdick said, although she’s unable to name for which customer.

Virtual reality is perhaps the technology with the most potential for changing the paradigm of how clinical trials are conducted as well as how patients learn what to expect during the course of a clinical trial. Think about a member of a team running a clinical study for multiple sclerosis patients learning what it feels like to have MS before the study starts.

Another area Quintiles is exploring is educating patients on informed consent as it pertains to participation in a clinical trial. Giving a patient the experience of what that looks like — prior to the patient actually experiencing it — is a way to bridge any sort of miscommunication between a patient and their primary care physician or specialist, and streamline the recruitment process.

Difficulties remain when it comes to pulling these sorts of digital health tools from studies into the realm of real clinical trials. For one, the devices used have to be validated by the U.S. Food and Drug Administration, and then investigators and clinicians will rely on devices like wearable monitors and VR headsets to perform accurately on a consistent basis.

“We’re doing some work in helping some of the device companies … try to figure out how to make sure those devices are validated and really can be used in trials,” Pike said during Quintiles’s latest earnings call.

Then there’s the problem of standardization. Wearable devices manufactured by different companies, for example, might record and catalog data in differing ways. Short of using the same wearable device for every clinical trial out there, Quintiles is doing some interesting work with Validic. The Durham, North Carolina-based company has developed a mobile API connection that allows data from a variety of wearable devices to be accessed.

Quintiles has hit some milestones. It has contributed open-source code to Apple’s ResearchKit to simplify how researchers gather more frequent and accurate data from research participants via iPhone. In June, Quintiles launched a continuous glucose monitoring service, combining consumer wearable devices and medical device CGM to record glucose readings throughout the day. In clinical trials, CGM readings can “improve patient safety, accelerate clinical development, and provide a basis for differentiated claims,” according to Quintiles.

Exactly how many months or years away Quintiles is from using some of the technologies under consideration at the studio in a fully fledged clinical trial is uncertain. But the prognosis, at least from Burdick’s point of view, is looking good. Digital health and remote monitoring will play an increasingly greater role in future clinical trials, helping to reduce the overall costs of those trials.

“Are there challenges? Sure,” Burdick said. “But it’s coming quick.”