The National Institutes of Health’s (NIH) program, part of the Precision Medicine Initiative (PMI) which launched in 2016, aims to enroll more than one million US participants by 2020.
The study is not focusing on a specific disease. Instead, researchers hope to create a platform to enable trials of targeted therapies and to gain a better understanding of the use of mobile health (mHealth), among other goals.
In line with this, the All of Us research program this week launched the Fitbit bring-your-own-device (BYOD) project – a “key step” in the program’s goal to integrate digital technology.
Participants now will be able to share data from their Fitbit accounts, in addition to providing information through surveys, electronic health records (EHRs), and biosamples.
NIH is planning to further incorporate digital health technologies in the program with a second Fitbit project slated to launch later this year. This will include providing devices to a select number of All of Us participants who will be randomly invited to participate.
According to the NIH, the program will add connections to additional devices and applications in the future.
Continuing BYOD momentum
John Reites, chief product officer and partner at Thread, said the announcement is yet another example of the continued momentum toward standard use of BYOD mobile and wearables for research.
“We are not only seeing this approach used in post-approval research and registries but also Phase II/III studies,” he told us, noting the several advantages to a BYOD approach, including increased insights with built-in patient engagement at lower costs.
“The challenges our industry is still working through for broader adoption of a BYOD wearable approach is that not everyone owns a wearable device, not everyone will opt-in/consent to donate their data and the outcomes gathered will likely support exploratory endpoints at first,” Reites explained.
However, today’s studies using this approach will help address these challenges, defining additional use cases for the future, he said.
“It’s great to see the All of Us Research Program and Fitbit team moving this innovative approach forward,” Reites added. “Examples like this study are enabling life science organizations to strongly consider BYOD wearable approaches for their studies.”