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It looks like the NIH may be the next big stakeholder to look to mobile tools for data collection in clinical research, joining the likes of Apple and Google. As part of the White House's Precision Medicine Initiative (PMI), announced in January during the State of the Union address, the NIH is considering using smartphones and wearables for data collection, according to a new post on the PMI blog. They are seeking public comments on how best to incorporate this technology.
In his State of the Union, President Barack Obama described the PMI as "a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes — and to give all of us access to the personalized information we need to keep ourselves and our families healthier." A more complete description came in a follow-up article penned by NIH director Dr. Francis Collins and NCI Director Dr. Harold Varmu, which stated that the initiative would include a longitudinal study of more than 1 million Americans. Last month, they solicited comments about what specifically to research. This month, the topic is how to use mobile health tools.
"Large studies on health and disease typically collect health and lifestyle data on participant volunteers from medical records and extensive phone or paper surveys," the NIH wrote in a blog post. "The Precision Medicine Initiative is considering using smart phone and wireless technologies to collect some of this information. These devices could provide the ability to track health behaviors and environmental exposures much more frequently with minimal burden on participants."
Research of this kind, using smartphones to collect information, is just beginning to see widespread adoption with initiatives like Apple ResearchKit and the Google Baseline Study. Through ResearchKit, Apple provides a set of tools anyone can use to conduct a study with Apple devices. Some concerns have been raised about the rigor and safety of this methodology, but it is being embraced by a number of well-respected hospitals.
In the blog post, the NIH lays out some further ways the devices could be used in the upcoming government-sponsored study. The description is similar to how smartphones are used in ResearchKit studies.
"For example, participant volunteers could respond to a few questions multiple times per day via their smartphones about their health status, activities, emotional states, etc," they write. "Location information from their smartphone or wearable device could be used to assess daily activity and also detect exposure to air pollution, etc. Wearable devices can assess heart rate and other physiological states as well as physical activity levels. Smartphones also could keep participants connected to the study, providing feedback on the data they provide as well as the aggregate data and findings of the study."
The NIH is accepting public comments through July 24th. They're particularly interested in feedback on how willing participants would be to carry smartphones and/or wear wireless devices; how willing participants without smartphones would be to upgrade (with the NIH funding the upgrade); and how often people would be willing to have researchers collect data. They're also looking to know what kind of data participants would be interested in getting back from researchers and what other ways exist to collect data remotely beyond smartphones and connected wearables.
