Participant Center taking shape for PMI cohort
The Scripps Research Institute in La Jolla, Calif., is playing a pivotal role in enrolling participants in the National Institutes of Health’s Precision Medicine Initiative, a national cohort of 1 million Americans who will contribute their physical, genomic and electronic health record data to the landmark study.
Under a five-year, $207 million NIH award announced last October, TSRI is overseeing the direct enrollment of 350,000 volunteers for the PMI All of Us medical research program, or more than a third of the targeted participants in the longitudinal study.
In addition, TSRI is charged with establishing a Participant Center to develop, test, maintain and upgrade the mobile apps and web-based platform that will be used to enroll, communicate with, and collect data from and share data with all 1 million U.S. volunteers.
“We’re responsible for everything that the participants see, including the website, the app, the data flow from the participants and data sharing back to the participants, as well as data security and privacy,” says Eric Topol, MD, professor of genomics and the Gary and Mary West Endowed Chair of Innovative Medicine at TSRI.
Topol, who is also director of the Scripps Translational Science Institute and chief academic officer at Scripps Health, is principal investigator for the NIH grant.
He notes that volunteers will enroll, consent and donate their data through vendor Vibrent Health’s technology platform using mobile apps, web interfaces, interactive voice response, feature phones and wearable sensors. At the same time, TSRI’S Participant Center will need to develop parallel platforms to deliver these same functions to those who don’t have smartphones.
As part of its grant for the Participant Center, Topol says that TSRI is also responsible for coming up with an engagement strategy to retain the participation of the 1 million All of Us volunteers and have them “stay with us for decades ahead.” NIH has set a goal of reaching 1 million volunteers within four to five years and hopes to continue to enroll participants well beyond that level.
“The data will be markedly diverse and not the usual,” observes Topol. “It will be highly diverse in every aspect—ancestry, age, gender, urban versus rural, you name it.”
In the past, leading genomic databases have lacked racial diversity and individuals of African ancestry have historically been underrepresented. However, the All of Us national cohort is designed to create one of the world’s largest and most diverse datasets for precision medicine research and to improve the ability to prevent and treat disease based on individual differences in lifestyle, environment and genetics. Participants will share a range of health data, including biospecimens, EHRs, mobile technology and surveys.
“We’re trying to find a million citizen-scientists who are going to be sharing their data and getting their data back, which has never been done before,” adds Topol. “In all medical research in the past, people didn’t get their data. They’ll be getting data back, which is very exciting.”
TSRI is on the hook to sign up a total of 350,000 volunteers for NIH’s All of Us cohort, while the job of enrolling 650,000 participants falls to healthcare provider organizations, including regional medical centers, federally qualified health centers and Department of Veterans Affairs’ medical centers.
For its part, TSRI is partnering with national drugstore chain Walgreens—among other partners—to help enroll the 350,000 direct volunteers for the study, according to Topol. “Walgreens is one of our partners,” he concludes. “They are part of the Participant Center.”