CHICAGO (GenomeWeb) – With the public launch of the All of Us cohort program for the Precision Medicine Initiative this month, the National Institutes of Health is directing potential participants to a web and mobile platform to enroll, share their health information, and register for program updates.
That portal, plus all the other consumer-facing technology that supports All of Us, was built by a relatively young vendor named Vibrent Health on its Learning Health System technology platform. Fairfax, Virginia-based Vibrent is the sole partner of NIH for the All of Us Participant Technology Systems Center, which provides a web portal, mobile apps, and other digital tools to support and enhance the experience of the 1 million or more expected participants.
"Everything about that launch was centered around what we delivered to the program," said Vibrent Founder and CEO Praduman "PJ" Jain.
"It's a huge deal," Jain added. "All of these participants [who] are interacting with the program are all coming through Vibrent's platform."
It is so significant, according to Jain, because All of Us is more than just a biobank. "This is the largest digital health research program in the making in the history of mankind," Jain said. He was not exaggerating.
"This is not a biobank only. This is not about collecting blood or genomics data," Jain explained. "It's really about understanding underlying factors that determine health of an individual and finding new scientific discoveries and cures. It's about understanding complex relationships [between] genomics, environmental exposures, lifestyles, [and] biological systems, then combining that with behaviors and lifestyles, and really looking at how an individual on a daily basis can live a better life and how populations can live better lives."
Vibrent Health got its start eight years ago as a data aggregator. For its first five years, the company worked with the National Cancer Institute, thanks to a series of small business innovation research grants, according to Jain said.
"Through those, we developed a really good understanding of what it means to be a system and a platform for either clinical research, digital health research, as well as in the area of digital health therapeutics," Jain said. That experience led to the Learning Health System aggregation and analytics technology, which Jain said has been piloted at institutions including Johns Hopkins, Stanford, George Washington University, and Northwestern.
"We were addressing a need for a bioinformatics platform that can bring in broad sources of data about a consumer," Jain said. He broadly defined "consumer" in this context as a participant in a clinical trial, a patient at any healthcare organization, or even someone with personal health improvement goals."All three of those use cases are covered by [our] bioinformatics platform," he said.
Jain said Vibrent has been in hiring mode for months, and now has close to 170 people working on the platform. He expects that number to continue to grow as All of Us recruitment accelerates.
He said that other consumer-facing bioinformatics companies have developed one-off digital applications for specific clinical trials or specific therapeutic uses.
"We are quite different in that we have a platform that goes across any of the conditions, whether it's cardiovascular, diabetes, whether it is condition-based or it is just population health-based. The platform bridges the translational gap between digital health and digital clinical research and digital therapeutics implementation," Jain said.
This, he explained, bridges the gap between clinical research, digital biomedical research, and digital therapeutics. "The idea is to create a pipeline-based, sustainable model where new scientific research in the area of digital health can be trialed, piloted on small to large populations," Jain said.
The Vibrent platform culls data from multiple sources, including electronic health records, genome analyses, laboratory results, wearable devices, behavioral reports, and environmental factors. "Omics is certainly a prime data source," Jain noted. It then applies analytics and machine-learning algorithms to produce recommendations that either clinicians or patients can act on.
Ahead of the national launch, NIH tested out protocols for patients to consent to the research, authorize sharing of electronic health records, and donating biological samples in a beta phase involving 129 clinic locations around the country. During the beta phase that ended with the public launch, 44,000 early participants signed up, and 26,000 people have completed the enrollment process, NIH reported.
For All of Us, the Mayo Clinic's biorepository has stored 800,000 tubes of samples donated by early participants. The program will collect 35 aliquots per participant, which means that for 1 million study volunteers, Mayo's biorepository will store 35 million samples. Vibrent is working with data generated from these samples, plus many other sources.
"We are able to deliver to each individual a personalized therapy, personalized prevention, [and] personalized intervention, on a daily basis," Jain said.
Vibrent sees enrollment in All of Us via the Participant Technology Systems Center as a mere starting point for longitudinal research, precision medicine, and patient engagement. "It's just a trigger," Jain said.
"The goal of this program is [for] citizens [to] become empowered to be able to help themselves," Jain explained. "That's the ultimate goal of this program, for what we call a citizen-scientist to look at their own data and start to derive some patterns. The system will help them with machine learning."
To get there, patients need to interact with the app on close to a daily basis. "As we all know, that's a really hard thing to," Jain explained.
Digital health companies have struggled for years to create "stickiness" so people have a reason to keep coming back, rather than following the common path of signing up for a health-related program or platform, then losing interest within weeks, days, or even hours.
"We clearly see drop-off. That's a given," said Jain. "It's about minimizing the drop-off. The good news is, there is going to be a lot of data about that individual in the app, so at least they can have a repository of their own health data that they haven't had in one place anywhere else."
Even the repository strategy is fraught with difficulty; no consumer-managed personal health records product has ever been successful in holding the interest of large groups of users for an extended period of time, in part because it has been difficult for such systems to import data from disparate locations.
Jain acknowledged that the Vibrent Learning Health System platform must offer both value and something consumers need to rely on in addition to data aggregation and useful analytics. He believes that the All of Us framework and the NIH brand will create value and reliance as a trusted source of information.
"People will get comfortable and they will recognize how valuable this is because now their health information is in one place, and they are able to do discovery by themselves," Jain said.
He added that this might be able to help consumers pick up trends from their own data, like seeing whether weather conditions combined with food or environmental factors are triggering migraines. "That person doesn't [currently] have the tools that can look at objective and subjective data," he said.
But the success of the participant center and of All of Us in general is about far more than the Vibrent Health technology.
"It's not just the application that will do it. Researchers will start to look at the data and ... come up with new pieces, new discoveries, new communications about what they found and how the program is helping people, so it's going to be a variety of factors that bring people back to the application, not just the app itself," Jain said.
"There's a movement beginning, where NIH will be messaging about what they found, how new discoveries are being enabled as there are new findings that may help people," he continued. "NIH will have a significant role in this from a messaging and communications standpoint."