When manufacturers “make this jump, they are now dealing with human subjects,” not just consumers, said Art Caplan, a bioethicist.
Several medical schools already are taking advantage of the new Apple technology. Using it, they say, will lead to greater understanding of the impact of diseases on patients' lives. “This is definitely a new era,” said Dr. Yvonne Chan, director of personalized medicine and digital health at Mount Sinai Hospital in New York City.
Mount Sinai uses an app called Asthma Health that it developed with San Jose, Calif.-based LifeMap Solutions using Apple's ResearchKit. It's intended to encourage patient education, self-monitoring and behavioral changes, ultimately leading to better asthma symptom control, improved quality of life and less need for healthcare services.
The asthma study is overseen by a multidisciplinary institutional review board led by Dr. Jeffrey Silverstein, senior associate dean for research at Mount Sinai. The researchers assembled a team of experts for the review board who could assess the application from a variety of perspectives, including statistics and ethics.
The University of Rochester also built its mPower Parkinson's app on Apple's ResearchKit. The app allows patients with Parkinson's disease to track real-time changes in balance, gait, vocal tremors and other symptoms. “There is unmet demand for tools by which individuals can measure the course of their disease and receive feedback on how they're doing,” Dorsey said.
Dr. Hardeep Singh, a quality and safety researcher at the Michael E. DeBakey VA Medical Center in Houston, said he worries about the quality of the health information obtained. The apps are available for download from Apple's app store to anyone interested in using them. And use of mobile technology does not happen in a controlled environment. “You can lose control in this virtual environment of big data,” he said.
Caplan cautioned that the results of app-based research might skew toward the population of people who can afford iPhones. “It's not necessarily representative of the problems of the poor, or the health habits of the uninsured or underemployed,” he said.
Mount Sinai is aware of those “potentially tricky” limitations, Chan said. But she noted that traditional medical research conducted in supervised settings is often skewed toward men of higher socio-economic classes, tends to be limited in geography and scope, and is generally more costly and time-consuming.
The larger sample size available through mobile devices can help expand the diversity of people participating in trials, Chan said. “The benefits and access to the broader population outweighs whatever limitation is posed by the inability to afford an iPhone,” Chan said.
In traditional clinical trials, informed consent often includes detailed explanations of the potential consequences, anticipated outcomes and patients' rights. Generally, it's obtained through face-to-face interactions.
But Evans said he found the consent information on the app was like an end-user license agreement, which most consumers can't decipher. “It starts with, 'Do you agree to?'—and 40 pages of legalese later, everyone has gotten bored and just clicks 'yes.' ”
The new Apple ResearchKit software allows patients to manually enter personal health data, but focuses on disease-specific medications and symptoms relevant to the particular study. Some of the apps are linked to GPS location services, which allow activity levels or environmental changes to be tracked, enabling researchers to corroborate what research subjects tell them.
For example, Parkinson's patients can record themselves saying “aaaah” for 20 seconds each day; the app can detect increases in vocal tremors, an indicator of disease severity. Asthma patients can key in how often they use rescue inhalers, as well as use the GPS feature to alert them when they are in geographic areas with high air-particle counts.
The goal is to eventually use the information to track the effectiveness of clinical interventions, guide clinical practice and provide medical feedback to individual patients in a timely fashion.
Apple aims to increase the value and experience of using its iPhones and boost sales. Apple says it does not hold the data, but simply acts as a pass-through between the patient and the researchers.
Within 72 hours of the release of the Apple ResearchKit tools, the Parkinson mPower app saw more than 7,000 downloads, while more than 4,000 individuals had enrolled in the asthma app study.
Singh and others say there are many questions that need to be asked as the technology rolls out such as: Who are the collaborative partners with whom the data will ultimately be shared? What are the chances that information that is supposed to be anonymous will eventually be tracked back to an individual patient?
“The more individual data points you have on a person, the closer you can come to using the rest of the Internet to figure out who that person is,” Evans cautioned.
Dr. Monique Anderson, a Duke University professor who studies the transparency of clinical trial data, said it remains to be seen whether these types of real-time observations through apps can be trusted and used to clinical benefit. If they do pan out, she said, they could bring revolutionary changes in research methods.
“This is an exciting time,” she said. “The more participants who can contribute to minimal-risk, big-data research that contributes to the public good, the better.”
—Darius Tahir contributed to this article