New Research Program Looks to Accelerate Precision Medicine

Age Distribution

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: 

• As of August 2019, All of Us has more than 245,000 enrolled participants, with more than 187,000 having completed all initial steps. 

• More than 80% of current participants come from communities that have been historically underrepresented in biomedical research, with more than 50% of them being from racial and ethnic minority backgrounds. 

• More than 80,000 participants have shared their electronic health records with All of Us.

• More than 190,000 biosamples have been collected.

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.”

To join, people must be at least 18 years old and live in the U.S. and can do so directly at www.JoinAllofUs.org/together, through the mobile app, or at a participating healthcare provider. 

Related: NIH to collect Fitbit data for research project

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.”

More research

“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:

• Scale-The program’s goal to enroll at least 1 million participants makes it one of the largest.

• Diversity-The program employs a “quadruple diversity” framework, which takes into consideration the diversity of people, diversity of health status, diversity of data, and geographic diversity. In particular, the program has a goal of at least 50% of participants coming from different racial and ethnic minorities and 75% from historically underrepresented populations in biomedical research.

• Depth-The program is collecting a wide range of data types, including surveys, electronic health records, physical measurements, biosamples, and data from wearable technologies. In the future, other data sources could be linked to the program.  

• Accessibility-The program will democratize research, making the data available to a wide range of researchers, including citizen scientists.

• Engagement-One of the program’s core values is engagement. Community organizations and participants are our partners and are involved in all levels of governance.

• Transparency-The program is committed to transparency and will give participants access to their information and return results to them responsibly.

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.