Is Apple already changing health care? Thousands sign up for trials through ResearchKit

But experts have reservations about the new research platform

Apple's ResearchKit, an open-source software framework that allows medical researchers to collect medical data through consenting iPhone users, has seen strong demand since it was unveiled on Monday, but some experts are advising researchers proceed with caution, Sabriya Rice reports for Modern Healthcare.

A surge in demand

By Tuesday morning, researchers at Stanford University reported that 11,000 people had signed up for a cardiovascular study powered by the software. "To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country," says Alan Yeung, the medical director of Stanford Cardiovascular Health.

Also see: What Apple's surprise announcement means for hospitals

Meanwhile, researchers at several other institutions—including the University of Rochester Medical Center and the Icahn School of Medicine at Mount Sinai—also are taking advantage of the new platform. "This is definitely a new era," says Yvonne Chan, Icahn's director of personalized medicine and digital health.

Ethical questions

However, Art Caplan, renowned bioethicist and founding director of NYU Langone Medical Center's population health department, says app developers should proceed with caution. "They're not dealing with just consumers anymore… they are now dealing with human subjects," he told Modern Healthcare.

Caplan says he is also concerned that iPhone-based studies will disproportionately focus on the affluent. Such studies are "not necessarily representative of the problems of the poor, or the health habits of the uninsured or underemployed," he says.

Dirty data

More broadly, some worry the convenience of ResearchKit will create problems of its own. "Just collecting lots of information about people—who may or may not have a particular disease, and may or may not represent the typical patient—could just add noise and distraction," says Lisa Schwartz, professor at the Dartmouth Institute for Health Policy and Clinical Practice.

Chan acknowledges getting iPhone-based research right can be "tricky." Icahn has assembled an unusually large institutional review board to oversee a ResearchKit study on asthma and ensure the project had proper oversight.

The New Yorker: The challenges for personalized medicine

Responding to concerns about data quality through ResearchKit, Chan points out that traditional research has its own limitations. Specifically, she says that samples are often skewed toward men, enroll more affluent test subjects, and are geographically constrained. "The benefits and access to the broader population outweighs whatever limitation posed by the inability to afford an iPhone," she argues.

And while the early trials have attracted thousands of sign-ups—and Apple has touted its 700 million iPhone users as a potential pool of trial participants—there's no guarantee that level of demand will consistently continue. 

"I like the direction it is going," the Advisory Board Company's Kenneth Kleinberg told the Daily Briefing. "But patients are still rightfully skeptical of the pharma industry, and I don’t see hundreds of millions of Apple users standing in line to do clinical research for them just yet."

More broadly, Todd Sherer—CEO of the Michael J. Fox Foundation for Parkinson's Research, which has developed a ResearchKit-enabled app—says he does not think Apple's software will replace traditional research. "But I do think this provides a complementary type of research in a different way," he says, adding, "Any kind of tool that will make it easier to engage more people in research is really important" (Rice, Modern Healthcare, 3/11 [subscription required]; Cortez/Chen, BloombergBusiness, 3/11).

The takeaway: Apple's ResearchKit software promises to make conducting large clinical trials easier, but experts caution the approach will leave some test subjects out and present quality problems.

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