PARADE Met Its Goals. What's Next?

Now that GlaxoSmithKline knows that an app-based, off-site health study can yield valuable findings, the pharma company hopes to further tweak and adopt the medium.

Michelle Crouthamel, GSK’s platform development leader in clinical innovation and digital platforms, pointed to the success of a proof-of-concept study called PARADE, which used Apple’s ResearchKit to mine pain and quality-of-life data from rheumatoid arthritis patients over the course of 3 months. The test, she said at Digital Pharma East in Philadelphia, proved that mobile studies can succeed in 3 critical areas: recruitment, esource data collection, and data quality. Plus, she said, the cost of the experiment ran about $500,000, as opposed to the usual $10 million.

“One thing that we found interesting, and why I think it enabled the study to be successful, is that we didn’t know patients are so ready for mobile,” she said of pharma’s first research effort of its kind.

So what’s next? Where GSK intends to go from here can serve as a guidepost for other tech-forward healthcare companies as they expand their research into the mobile realm.

Wider Adoption

After PARADE’s completion last November, team members began to share their results throughout the company. Since then, Crouthamel said, confidence in mobile health research has blossomed at GSK. Employees hope to use the model in Phase 4 work, when the FDA has already approved a drug and the “safety risk is discharged,” she said. But app-based research could occur as early as Phase 2.

Crouthamel saw PARADE’s findings as a chance to introduce a hybrid data collection system. Under that plan, researchers could gather information on site, face to face, as per tradition. Then, she said, patients could use the app to send additional details as the device’s sensors record more objective data. “You can use this platform to get a lot of data from the patient that you wouldn’t normally get,” she said.

Fixes

Despite the positive results, PARADE and similar studies have highlighted areas in need of improvement.

One, for example, deals with recruitment. Although Crouthamel exceeded her goal of 300 participants, she acknowledged that bots and malicious actors could game the system and wrongly enroll in a virtual trial. How can GSK and other healthcare companies avoid that? The solution could include a site-based feature in which patients receive an activation code from a physician to verify their identity, Crouthamel noted.

The quality of the data depends on better instruction, she said. Participants of an Apple pilot were instructed to walk 10 steps, but they often left their phone on the table, rendering the data undocumented, Crouthamel said. Similarly, as the phone spouted directions from other users’ pockets, they removed the device to listen, which ruined the exercises

Nurses and doctors aren’t available to give clear instructions to participants, so the app itself will need to take on that role. In the future, Crouthamel added, the program must be able to tell patients whether they’re performing a task correctly or should restart the process.

Patient Experience

GSK also learned what PARADE’s participants wanted from the exchange: data. One cohort could access real-time data on their wrists’ range of motion and pain mapping, while the other could not. Yet each group regularly checked the data section of the app, eager for numbers, Crouthamel said. And 83% said they hoped to share this information with their healthcare providers. So the data itself can be of great value to patients, a lesson for other organizations that hope to enter this space.

To that end, GSK is shooting to enable participants to use this sort of app to monitor and manage their own conditions. That, in turn, can help boost drug adherence and ultimately bring each patient as a “partner along for the journey,” Crouthamel said.

Regulations

The PARADE team is slated to soon discuss sensor data with FDA regulators, she said. The agency has focused more resources on digital in recent years, but how clinical research through mobile apps will be controlled remains to be seen.