Launching All of Us, a Historic Precision Medicine Initiative

"One size fits all" doesn’t work well when it comes to healthcare.

Yet, historically, that’s been the reality behind most medical treatments, which are based on a largely homogeneous group of research participants. There's often little diversity in race, socioeconomic status, gender, or age. However, a treatment that works well for a 30-year-old white male may have a very different result for a 60-year-old black female. What’s more, there's ample evidence that those historically underrepresented in clinical trials and research programs—including minorities and the socioeconomically disadvantaged—have a greater incidence of disease and poor health.

Many scientists and healthcare providers believe precision medicine is the correction to the one-size fits-all paradigm. In 2015, the National Institutes of Health (NIH) enlisted the MITRE-operated Health FFRDC to help pilot the All of Us Research Program with six federally qualified health centers (FQHCs)—and then to support the 2018 national launch.

According to Erin Williams, who leads biomedical innovation programs at MITRE, "Precision medicine is aimed at getting the right medicine to the right person, at the right time and at the right dose. By trailblazing together with government agencies to make All of Us a reality, we’re reaching people who may not otherwise have been included in cutting-edge medical research and helped by its advances."

To explain the benefits of precision medicine, Eric Dishman, director of the All of Us Research Program, has created a number of videos. He speaks from personal experience with cancer. "I'm alive today because of precision medicine, and I think everyone deserves that same opportunity, no matter the color of your skin, your economic status, your age, or your sex."   

The Treatments of the Future Need More Data

Achieving precision medicine takes participation from a diverse population of individuals to generate a rich research data resource. That's what researchers need to develop the treatments of the future: data from as many people as possible, from all walks of life.

In the All of Us Research Program, participants are asked to share different types of health and lifestyle information through online surveys. After that, if participants enrolled at a health center where they receive care, the health center will continue to collect data from patients’ electronic health records over the course of the program. The NIH is piloting methods that will allow participants who enroll outside a health center (direct volunteers) to also share their medical records. Some participants will also be asked to provide blood and urine samples and basic physical measurements, such as height and weight. Participants may be able to learn about their own health as research yields results, and they will contribute to an effort that may advance the health of generations to come.

NIH believes that by enrolling one million or more volunteers, the All of Us Research Program will have the scale and scope to enable research for a wide range of diseases, both common and rare, as well as to improve researchers' understanding of what is means to be healthy. As the volume of data grows, patterns will emerge that wouldn’t be visible at a smaller scale.

In future phases of the program, children will be able to enroll, and the program will collect more data types, such as genetic data. In addition, data from the program will be broadly accessible for research purposes. Ultimately, the All of Us Research Program will be a rich and open data resource for traditional academic researchers as well as citizen scientists—and everyone in between.

According to Health and Human Services Secretary Alex Azar, "All of Us is an ambitious project that has the potential to revolutionize how we study disease and medicine."

Piloting All of Us with Six "Safety Net" Federally Qualified Health Centers

In 2016, MITRE created the framework for involving FQHCs in the All of Us Research Program. Our team and NIH collaborated with six centers in California, Connecticut, Mississippi, New York, Tennessee, and South Carolina.

"These centers are truly the safety nets for their communities," says Joan Grand, principal health quality technologist, who led the pilot for MITRE. "These are clinics within neighborhoods that people depend upon for primary, dental, and psychiatric care. We were asking these clinics to leverage their relationships with their communities for a program that was, in fact, a ground-up effort."

As thought leaders who specialize in collaboration and bringing innovative ideas to fruition, we helped each center participate actively in the startup. "For instance, we worked with NIH to ensure that teams from even the smallest centers were given the same opportunity to contribute as the experts from large academic medical centers," Grand says.

Grand's team worked with the FQHCs and NIH to implement the national protocol in the FQHC setting, including developing and testing processes, systems, and approaches. The team helped determine how the FQHCs will enroll, engage, and retain program participants; facilitate and beta-test materials and technical interfaces; share structured electronic health record data; collect physical measurements; and collect, process, store, and ship biospecimens. Throughout, MITRE helped ensure the centers could both meet their patients' needs and follow the meticulous national protocols of the All of Us Research Program.

"We performed data collection, evaluation, and forecasting to help NIH better understand the long-term costs," Grand says. "At least initially, center employees will engage potential participants while they enroll and enter data one on one in the FQHC. We're helping NIH determine whether that 'high-touch' approach will lead to better retention and be a good return on investment."

Launching All of Us to Begin Enrolling One Million Participants

In the fall of 2017, MITRE’s role expanded to include work with the All of Us senior team to ensure a successful national launch on May 6, 2018, to open the program to everyone in the nation.

"Our team was brought on to provide strategic and associated management support for a strong start to the national launch of the program," says MITRE's Grace Moon, a principal scientist for population health and innovation. Joining the project six months before the planned launch, Moon explains, the MITRE team had to quickly learn about the program and its launch activities and assess the status of those activities.

Moon's team shepherded the complex process of designing, developing, and deploying the core elements of the All of Us program, including the participant portal, the JoinAllofUs.org websites, program policies and protocols, and educational and communications materials. The MITRE team worked with the All of Us senior team to develop a dashboard to monitor and track the progress of the launch activities. MITRE identified potential risks and provided strategic recommendations about alternative paths based on risks and opportunities.

Additionally, the team helped coordinate the "bug-bash" sessions to test the strong security measures that are in place for the participant portal and the program website. To encourage diverse communities to participate in the program, the MITRE team worked with the All of Us consortium on the Spanish translation and deployment of all program content into the participant portal and the website.

By any measure, the launch was a success. Seven launch events took place nationwide, and the online portal began enrolling participants in large numbers. As a result of the beta program and the launch, All of Us has enrolled 98,000 people as of August 2018 with 49,000 of them having completed the full enrollment protocol.

"Getting to success took a lot of hard work by NIH and CAMH," Moon says. "But we shared NIH's commitment to the vision of the All of Us Research Program, and we feel honored to have been part of the process to support NIH in officially launching the program successfully."

Enroll Now in the All of Us Research Program

If you'd like to learn more about the launch, see the welcome video, or enroll in the All of Us Research Program, visit the program’s website. The future of health begins with you.

—by Bill Eidson