By Benjamin Ross

March 22, 2019 | SAN FRANCISCO—In 2015, Apple announced the launch of ResearchKit, a software framework to help researchers gather data from study participants using mobile devices. At the time, five medical facilities, including Mount Sinai in New York, were selected to conduct clinical trials using ResearchKit. The trial conducted by Mount Sinai’s Icahn School of Medicine, used the hospital’s Asthma Mobile Health study app to recruit and track a large number of asthma patients in their day-to-day lives.

Yvonne Chan, director of the Center for Digital Health at Mount Sinai, spoke at the Molecular Medicine Tri-Conference in San Francisco earlier this month about the results of that trial and the overall impact wearables can have in clinical trails and diagnostics moving forward.

“The most important goal for us was to show we could conduct a clinical observational study in its entirety using a smartphone,” Chan said. “We’re poised to do some pretty amazing work and transform the way clinical research is done, which essentially hasn’t changed in centuries.”

The use of the mobile app expanded the scope of the trial, said Chan. Essentially anyone could download the ResearchKit app and enroll in the trial, eliminating one of the key issues clinical research sites face when conducting a trial: recruitment.

Apple’s marketing presence certainly had an impact, Chan said. Thousands of patients enrolled in the trial in three days. “It was astounding to us to reach such a wide geographical range in a short amount of time,” said Chan. “Assuming there’s a way to get the message out there, then a typical barrier to clinical research could be removed.”

Another concern for clinical researchers is the data, said Chan. Will the data collected in trials such as this be useful, and will patients be willing to share their data in the first place? Because the trial was conducted with mobile devices, the majority of the data was collected passively.

“A new tool isn’t always useful or meaningful,” Chan said. “So what kind of data we gather is important. Are people randomly putting in garbage, or are we getting valuable, useful data?”

The answer was an overwhelming yes, Chan said. “To a pulmonologist, if their patient’s peak air flow dips below 40% of their personal best, their patient’s in trouble and [the physician] wants to be notified. They want this data because it’s important and it’s actionable.”

“Not only do we find patients are willing to participate in clinical research, they want to share their data,” Chan said. “I believe it should be common practice to ask the patient point blank, will you share your data? The vast majority of the time the patient will share their data.”

10,000 patients participated in the initial study, tracking their asthma symptoms, completing surveys, and participating in active tasks prompted by the app. The app in turn would give feedback on the patients’ progress, provide education on asthma, and offer personalized reminders for medication.

“When we set out to do this study, we were designing a research app to enable good asthma research, not so much a clinical tool for clinical care and management,” said Chan. “But despite all of that, we found our patients gained more insight into their disease. We received so many comments saying, ‘I’ve had asthma for decades and I didn’t put two and two together that when I go to this place at this time of the year I get symptoms until this app.’”

Though the study yielded promising results, Chan is the first one to offer areas of improvement moving forward, one example being the selection bias of the technology used in the study. Because this study was conducted using Apple’s ResearchKit, it was inherently limited to patients using Apple products. Chan said there are plans in the works to incorporate an Android mobile app.