How a program with a goal of 1 million participants could help promote research into precision medicine.
The National Institutes of Health’s All of Us Research Program launched across the United States in May 2018, and it seeks to enroll 1 million or more individuals living in the U.S.
The All of Us Research Program is being conducted in an effort to accelerate precision medicine, which has the potential to fundamentally shift this paradigm. Precision medicine is a revolutionary approach for disease prevention and treatment that takes into account individual differences in lifestyle, environment, biology, and more.
“With a plan to follow the health and outcomes of participants over decades, the All of Us Research Program should enable research that provides an improved understanding of health and disease, which in turn would support accurate diagnoses, rational disease-prevention strategies, treatment selection, and the development of targeted therapies,” says Dara Richardson-Heron, MD, chief engagement officer for the All of Us Research Program. “Since its nation-wide launch, the program has met more than one fifth of its recruitment goal.”
While public information about the program is at this point limited, there is some initial data that Richardson-Heron can share about All of Us participants:
The public can begin looking into some of the initial findings and get a high-level, aggregate overview of the program’s current data through the recently-launched Data Browser.
“For far too long, the U.S. healthcare system has employed a “one-size-fits-all” approach. This means the treatments patients are receiving don’t vary based on their own backgrounds and unique health indicators,” she says. “These treatments are often based on research from participant pools that do not reflect the true diversity in the U.S. In order to ensure medical advances coming from All of Us research benefit us all, it’s crucial to involve people that have historically been left out.”
After participants complete the consent process, they will be invited to give access to their electronic health records and be asked to complete surveys. Participants may also be asked to visit a local partner site to have their physical measurements (blood pressure, height and weight, etc.) taken and to donate blood and urine samples. As the program progresses, participants will be invited to share additional data through such means as new health surveys and health trackers.
The All of Us Research Program anonymizes participant data to protect individuals’ identity, and then adds it to our database, which researchers will then be able to access and use in their development of new treatment and prevention methods.
“Healthcare executives are intricately involved with our care system and are aware of the health discrepancies that many underrepresented communities face,” Richardson-Heron says. “The All of Us Research Program is partnering with healthcare providers across the country to advance precision medicine. In the near future, researchers will have access to data that can help them better understand health and disease. In turn, this program could help better match people with the right clinical studies, determine which treatments work for different types of people, and explore how technology can encourage people to take better care of their health. All of these advancements can help drive efficiency and better outcomes for the U.S. healthcare system.”
“There are many other large cohort programs doing important work and, from our perspective, the more research the better,” Richardson-Heron says.
However, there are a few factors that set All of Us apart:
In addition, the program announced its partnership with Color, a health technology company in Burlingame, California, to establish the nationwide All of Us genetic counseling resource. All of Us plans to sequence the genomes of its 1 million participants and Color’s network of genetic counselors will help them understand what the testing results mean for their health and their families.
“Over time, the program anticipates providing several kinds of information to participants, including information on ancestry and traits, drug-gene interactions (pharmacogenomics) and genetic findings connected with high risk of certain diseases,” Richardson-Heron says.
Genomic results from All of Us, although produced at a high quality in specially certified labs, should be confirmed by a healthcare provider before a participant makes any changes to their care.