A little more than a year since the National Institutes of Health embarked on the All of Us Research Program journey, it is on track to become one of the most influential research programs undertaken in the realm of precision medicine.
The 10-year-long program is impressive in size—a planned 1 million participants—and in scope, too, as it’s designed to reflect the country’s rich diversity.
By analyzing data on health, lifestyle, medical history and genomics from a diverse pool—all races, ages, socioeconomics, geographies—researchers aim to improve their understanding of human health and disease.
The findings are expected to help doctors and researchers arrive at medical treatments best suited to individual needs, a hallmark of precision medicine.
Researchers recently published a scientific paper on the program in the New England Journal of Medicine, highlighting in part some of the characteristics of those who have enrolled thus far.
The 1 million-person enrollment goal should be reached sometime in the next five years, said Dave Chesla, PA, director of research operations at the Spectrum Health Universal Biorepository.
National Institutes of Health director Francis Collins has described the All of Us program as unprecedented in its aims.
“This is going to be written about, I think, decades from now, as one of those signal moments where we went from a general sort of one-size-fits-all approach to medicine to understanding things about the individual that gave more and more people a chance to live healthy lives,” Collins has said. “Or, if they happen to fall ill, to get the kind of intervention that’s right for them, instead of something that might have been OK for the average person.”
The spotlight on precision medicine is what prompted Paula Schuiteman-Bishop to enroll in All of Us this spring.
Schuiteman-Bishop, Spectrum Health vice president of medical education and research operations, became Spectrum Health’s 3,000th All of Us participant.
“This shows that we already have 3,000 incredible personal commitments from around our greater community who want to better understand disease and create a healthier population in years to come,” Schuiteman-Bishop said shortly after her enrollment. “Precision medicine is the future.”
Spectrum Health is creating its own precision medicine strategy that will impact patients moving forward, she said.
“The All of Us study represents an incredible opportunity for us to learn about how our individual differences can help improve health and treat disease,” Schuiteman-Bishop said. “I personally wanted to help drive the change that is needed in health care for the future.
“Through important and innovative research studies, such as the All of Us study, clinicians will be able to tailor specific medical treatments to the individual characteristics of each patient,” she said. “How powerful is it that I will be part of the 1 million research participants who will change the future of medicine?”
Dozens of health care provider organizations throughout the U.S. are partnering with the program in their respective communities. Spectrum Health is part of the Trans-American Consortium of All of Us, along with Henry Ford Health System in Detroit and Baylor Scott and White Health in Dallas.
The notion of contributing to a medical study that could change the trajectory of health care for future generations is an enticement for enrollees, Chesla said.
“It’s about the we,” Chesla said. “Not the me.”
All of Us participants undergo a series of health questions on enrollment, providing researchers a glimpse at their health history, family history, lifestyle, home and work environment and the like. They’ll submit urine and blood samples, too, the latter undergoing genetics analysis.
As scientists study all this genetics material with existing technology—or, one day, with technology yet to be developed—they could make new discoveries, Chesla said. The gaps in genomics knowledge continue to drive modern research.
“BRCA seems to be the one that everyone understands for breast and colon cancer,” Chesla said. “It’s got a lot of visibility because Angelina Jolie, the actress, had a bilateral mastectomy because she tested positive for it.”
An All of Us participant whose biosample shows a BRCA gene mutation would be notified of a finding, with a genetics counseling center notifying participants of any important findings.
Statistically, about 400 out of 25,000 people will have some type of genomic finding.
Collins, the NIH director, has indicated the All of Us genomics data may be more robust than what participants find in a commercial genetics service.
“As part of this study, people will be having a very detailed analysis of the DNA derived from the blood sample,” Collins said. “We have brought on three of the most advanced genomic centers in the country—actually, in the world. They’re our partners in doing this.”
Data in, data out
In the coming years, the program’s success will likely be measured by the answer to a single question.
“Is it changing health outcomes?” Collins said. “Are we, as a result of this, helping more people have healthy lives, untroubled by medical illnesses?”
Participants are asked to not lose sight of the need to engage in the program long-term, which will contribute to their own health knowledge and to the larger body of research.
“This a phenomenal value right upfront because you’re actually going to learn something about yourself,” Chesla said. “The fact of the matter is, the longer you stay engaged, the more information you’re going to get back.”
Participants can access their health data in an online patient portal. It gives them the ability to compare their own results to others in the study.
“The more information you put into the program, the more you’re going to get back,” Chesla said.
And as scientists study each sample, they’ll extract greater knowledge from the data.
Of the tens of thousands nationwide who have started the enrollment process, many have yet to complete it. In the West Michigan area, for example, 9,500 people have begun enrollment but only about 4,000 have fully enrolled, Chesla said.
The program’s outreach efforts are now aimed at tightening these sign-ups.
“We’re doing a fair bit of outreach … to increase awareness—a close-the-gap campaign,” Chesla said.
This involves explaining what’s required of participants, what they’re contributing and what they can expect to get back, along with details on the extensive security measures in place.
Schuiteman-Bishop said she’s eager to see the program evolve in the coming years.
“I have not yet had any surprises of my own health history, so it will be interesting to follow as it develops,” she said.