File – Dr. Michael V. McConnell, a cardiologist who uses an app to study heart disease, poses with his smartphone outside the Stanford Medical School in Stanford, California, July 7, 2015. Scientists like McConnell who are overseeing studies that use specialized iPhone apps say they have the potential to transform medical research by collecting data routinely from more people than usually participate in clinical studies. (AP)

Mobile technology is giving experts the tools they need to expand clinical studies and collect a wealth of data for medical research. But this approach faces challenges and is unlikely to supplant traditional clinical research.

“Consumer technologies, apps, wearables – all of those things basically are entering into and [are] being accepted into the biomedical research enterprise,” said Brad Smith, Director of Policy at FasterCures, a non-profit action tank focused on accelerating medical research.

Using wearable devices, health platforms such as Apple’s mobile ResearchKit, clinical researchers can create specialized apps to collect real-time data for longitudinal studies to better understand disease progression, or even how the normal brain works.

“You can actually collect data every day, maybe every hour, for example using the smartphone or other device,” said Smith. “And that data can be uploaded into the clinical trial data system and it essentially allows you to collect potentially much richer, much more high frequency data at a much lower cost.”

In some cases, traditional clinical studies can be prohibitively expensive. “Imagine a study where you enroll thousands of people and collect data on them for 50 or 60 years … It’s very, very expensive,” said Paul Tarini, Senior Program Officer with the Robert Wood Johnson Foundation, which funds health research.

Rather than mailing out thousands of paper applications, researchers can register volunteers and obtain their informed consent for healthcare intervention on mobile devices. And instead of driving long distances in some cases to reach a research facility, volunteers can now use their smartphones to participate.

During a recent asthma study, Dr. Eric Schadt, Founding Director of the Icahn Institute at Mount Sinai in New York, put the feasibility of mobile clinical research to the test.

A screenshot shows various features of the health app used in Mount Sinai’s Asthma Mobile Health study in New York. (Icahn Institute at Mount Sinai)

“One of the primary goals of our Asthma Mobile Health study,” he said in an email, “was to determine if it is feasible to conduct clinical research using a smartphone, specifically, electronic recruitment, electronic consent, remote enrollment of subjects into a study, and collection of study data, without any direct contact with study investigators.”

The mobile study enrolled up to 10,000 participants without direct, in-person contact. Thousands more downloaded the research app and met the rigorous eligibility criteria. The research also broke the geographic barrier that typically limits traditional studies to a local area of a university or medical center. So while volunteers living far from a research site might be reluctant to make the trip, those participating in the mobile asthma study represented all 50 U.S. states.

Schadt said the “ubiquity of the iPhone” enabled researchers to “recruit ‘wide and deep’ in a way that would match a far more expensive, national clinical study done in the traditional manner– enrolling people [in a direct way, with research personnel] in every state.”

In another case funded by the Robert Wood Johnson Foundation, non-profit Sage Bionetworks reached more than 9,000 volunteers for a Parkinson’s study using Apple’s ResearchKit. Sage has been studying fluctuations associated with Parkinson’s, a disease that causes tremors and impacts mobility and memory, on an ongoing basis.

A screenshot from Sage Bionetworks’ Parkinson’s mobile app shows some of the agility tests that Parkinson’s patients can do to measure their dexterity over time. (Sage Bionetworks)

Parkinson’s patients can experience dexterity fluctuations that vary greatly over time. An occasional visit to the doctor might not be enough to gauge the extent of the fluctuations, whereas daily tracking of walking, for example, will show them more clearly.

But mobile clinical research is still in its early stages, and there are challenges that have to be met before it goes mainstream.

While Sage, Mount Sinai and other researchers have already published their findings, research using mobile platforms is still not published in large quantities in peer-reviewed scientific journals.

Researchers also lack the ability to deploy their apps across all mobile platforms and must ensure that all participants have access to smartphones. They need new skill sets to analyze the vast wealth of information coming in from both active questionnaires and passive data collection such as GPS location information and other indicators.

Until those issues are addressed, it is unlikely that clinical research on mobile devices will replace traditional methods, said Smith. There will be situations where participants still have to go to a medical facility for tests.

Researchers are trying to determine the best cases where mobile studies can be done with maximum value, and how the data can be analyzed, interpreted and shared to benefit both researchers and participants – and more importantly, protected.

With all of this massive sharing going on, Schadt said securing the collected data is a priority that cannot be taken for granted and “will require ongoing scrutiny and vigilance from scientific research teams.”

While it is impossible to guarantee 100 percent security, particularly with data gathered over years and decades, Smith said researchers are focused on finding ways to secure the information and respond quickly if the need arises. He said building this kind of trust between researchers and participants is crucial if mobile technology is going to be the future of clinical research, as he believes it will be.

“It is really going to change the way that biomedical research is done,” he said.

More than that, added Tarini, is that the “ability to conduct research where the smartphone is the data collection device, really starts to democratize research. It opens it up … It just makes it able for many more people to participate. And that’s a tremendous benefit.”