The results pleased not only the study’s creators, but also some of its skeptics. When GlaxoSmithKline undertook PARADE in July 2016, the pharma giant intended to gauge the effectiveness of a clinical trial conducted entirely off-site, in the virtual realm, through Apple ResearchKit. By last November, the researchers had hit their 3 objectives and then some.
“So overall, that was a successful small pilot with a very small cost,” Michelle Crouthamel, the company’s platform development leader in clinical innovation and digital platforms, said at Digital Pharma East in Philadelphia.
Over 3 months, PARADE collected pain and quality-of-life data from rheumatoid arthritis patients through a mobile app, according to GSK. Yet in that short window, Crouthamel said, the trial showed how a digital study can draw participant interest, streaming esource data collection, and get quality data—at a cost of $500,000, far below the typical $10 million price tag. For healthcare and research companies, the implication was clear: Take the medium seriously.
GSK hoped to enroll 300 people from across the country over 1 month. With $40,000, it placed ads on Facebook, targeting 5 states with high concentrations of RA patients, Crouthamel told the crowd. More than 1,100 people downloaded the app, and 35% went on to provide consent and enroll in the trial, she said.
What’s more, 73% later told GSK that they preferred to participate in a mobile study to a traditional clinic or hybrid design. Crouthamel acknowledged that the figure could be biased, since that sentiment came from people who had already signed up for a digital study, but she argued that the number would remain significant even if it shrunk.
“Pharma can choose to listen to the voice or not,” she added. “I think it would be a missed opportunity if they chose to ignore this.”
Electronic Data Collection
For a few months, participants used an app on their phone to self-report information on pain and their body. But the tech also used sensors to record objective data, Crouthamel noted.
Although the trial compiled a trove of material, it was manageable and did not overburden the system, she said. In total, after working with the data, the company got its size down to less than that of Crouthamel’s PowerPoint presentation, she said.
The digital trial cast a wider net, soliciting a diverse base. Crouthamel said 20% of enrollees were not white, an important leap from 4% in the RA patient registry. The disorder also mostly affects women, which was reflected in this examination. But PARADE consisted of people who were younger and more educated than is typical, she said.
Using several tools, GSK measured participants’ pain and other health information. The app made sure their medications matched those of the usual joint pain sufferer. The company also developed a tool to more accurately inspect the wrist’s range of motion. Crouthamel warned that organizations will need to develop their own algorithms to perform such tasks, as the inner workings of wearables have sparked intense competition.
And there is room for things to go wrong. For instance, Crouthamel said, people in an Apple pilot who were instructed to walk 10 steps would often leave their phone on the table, rendering the data unable to record.
GSK’s efforts, however, paid off. Researchers found a correlation between joint pain severity and the wrist’s range of motion, she said. “We learned a lot of incredible RA insights,” she added. “We also developed a potential novel endpoint that we can further validate in the interventional study.”
As for mobile clinical trials in general? They’re just getting started at GSK, Crouthamel said, and others would be smart to follow.