A groundbreaking research study will soon be assembling health data from more than 1 million Americans.
In fact, researchers have begun testing their digital platform with more than 3,000 of those individuals in preparation for a national launch next spring.
The study, named “All of Us,” is led by the National Institutes of Health (NIH).
Its goal is to shepherd in a new era of healthcare with “precision medicine.” It’s an approach that personalizes diagnosis and treatment of disease by examining how biology, lifestyle, and environment come together to uniquely cause illness in each person.
The promise of revolutionizing medicine is what convinced Terri Shomenta Bailey to participate in the study.
Bailey’s best friend had recently passed away from cancer when she first learned about the study.
“My best friend died of melanoma. It’s a melanoma that Jimmy Carter had and he survived it, yet my best friend, who was only 52, passed away. Precision medicine can figure out why my best friend died and why someone else on the same drug survived,” Bailey told Healthline.
“If there was anything I could do, small or big to help researchers discover why some people recover from cancer and others don’t, I wanted to contribute to that,” she added.
Data and diversity
The research hinges on recruiting a diverse cohort of people.
Scientists hope to gather data that they can use to investigate how individual differences — like genetics, behavior, race, ethnicity, age, geography, sexual orientation, and socioeconomic status — influence the development of disease and response to treatment.
A significant portion of the medical research that drives clinical decision-making today largely comes from Caucasian males.
The NIH has promoted gender, racial, and ethnic inclusivity since the 1990s. But biomedical research has been slow to catch up.
Esteban Burchard, a researcher at the University of California, San Francisco, who’s advising the “All of Us” initiative, described why diversity is integral to medical care and scientific advancement.
“Medications work differently in various racial or ethnic groups,” Burchard told Healthline. “Plavix, the blockbuster heart drug, doesn’t work in about 50 percent of Asians and 70 percent of Pacific Islanders. The most recent cholesterol-lowering drug in the market, it was first discovered based on a mutation observed in African Americans, but the drug works equally well in everyone.”
“All of Us” researchers hope to do their part to reverse that precedent.
Stephanie Devaney, deputy director of “All of Us,” declared that engagement was “a core part of our mission.”
So far, the initiative has forged more than 50 partnerships with hospitals, universities, federally qualified health centers, local community groups, nonprofits, and blood banks across the country to act as intermediaries between the program and local communities.
At the University of Arizona, an “All of Us” partner site located in Tuscon, efforts are under way to engage the local Hispanic and Latino population, tackling barriers that have historically led to under-participation by minority groups.
Those barriers include inadequate access to clinics and hospitals, financial constraints, lack of access to information, limited comprehension about research, and cultural and linguistic differences.
“It’s an issue of health equity in not being able to convey information in a way that resonates with minority communities. It’s essentially the same as not providing access,” Usha Menon, the co-principal investigator at the University of Arizona, told Healthline.
Getting the word out
Research staff at the University of Arizona are working closely with community champions and opinion leaders to get the message out about the study.
“Testimonials are quite effective,” said Menon.
The group also has bilingual and bicultural coordinators on hand to assist with study enrollment and procedures, in addition to providing materials in Spanish.
Across the nation, other groups, such as the Nashville-based organization FiftyForward, are helping to recruit older adults, while the San Francisco General Hospital Foundation is leading the effort to engage sexual and gender minorities.
Bailey, who was the sixth study participant in Arizona, described the process of participating “easy and painless.”
After initially signing up for the study, researchers called her in to complete a comprehensive health history, get basic measurements like weight and height, and collect blood and urine samples.
Once launched nationally, individuals will also be able to directly sign up online without going to a study center first. This mechanism is being piloted at the San Diego Blood Bank.
“For people not immediately connected to a clinic, we’re working with blood banks, Walgreens, Quest Diagnostics, and EMSI — an organization that goes to people’s homes, like those who are homebound or elderly — for biospecimen collection,” said Devaney.
Though the “All of Us” platform is currently only online, Devaney said they intend to develop a paper enrollment process and build partnerships with local libraries to mitigate the digital divide.
Eventually, participants will be able to access their health information online as researchers collect and analyze data in real time — a departure from traditional research norms.
“It takes an average of 17 years before the person who provided research data will be impacted by it,” said Menon. “With this program, enrollees will have access to their information, will be able to download it and share it with their primary care provider, and look and see what kind of testing is being done with what they provided.”
“Ultimately, we plan to return all types of data — genetic data, electronic health record data, survey data — and also embed an individual’s information in their cohort so they can see how they compare,” explained Devaney.
For Bailey, this is an added perk to participating. But she’s intrinsically motivated by the incredible potential of this initiative to reshape medicine.
“We’ve got to be more focused on why some people live and some people die. We want to do everything we can to be smarter than these diseases,” she said. “I hope this study does right by the American people and all ethnic backgrounds, helping everyone live longer and healthier lives.”