In 1969 the United States was the first nation to land a man on the moon. Forty-nine years later this country is poised to take another “giant leap” for humankind, this time by unleashing a revolution in medical research and human health.
The effort, called the All of Us Research Program, aims to recruit 1 million or more American volunteers who, by sharing their health data, will help accelerate discoveries in understanding, treating and preventing a host of diseases.
The goal is to tailor health care to the individual by understanding genetic, demographic, environmental, occupational and lifestyle factors that can affect their wellness. All of Us ultimately will lead to more effective treatments with fewer side effects, improved prevention strategies and better overall health — for everyone.
“No more one-size-fits-all, but optimized for each particular person — that’s a concept we now call precision medicine,” said Francis Collins, MD, PhD, director of the National Institutes of Health (NIH), which supports and officially launched the public enrollment phase of the program May 6.
Participants age 18 and older can sign up at the All of Us website, https://www.joinallofus.org/en, available in both English and Spanish.
They will be asked to complete a series of online surveys about their health and to authorize access to their electronic health records (EHRs).
Some will be asked to go to a collection site, such as a healthcare provider organization or clinic, to provide physical measurements and blood and urine samples. Some participants also may be asked to share information from devices that track their activity level throughout the day or measure their blood pressure.
From all of these data researchers will be able to glean new clues to health conditions and illnesses. Information will be returned to participants who submitted samples so they can learn important information including genetic risk factors and environmental exposures that may affect their health and the health of their families.
“I’m definitely all in today,” Tennessee Rep. Brenda Gilmore, D-Nashville, said Sunday during Nashville’s launch event hosted by FiftyForward, an advocacy and service organization for people over 50.
“I want to do my part in ensuring that my daughter, my granddaughter and future generations live healthy lives,” Gilmore said.
All of Us was made possible by the sequencing of the human genome, essentially the first complete reading of the DNA code in the human genetic “book of life,” and by equally astonishing advances in computer science and biostatistics that enable researchers to analyze huge amounts of data.
Vanderbilt University Medical Center is a world-recognized leader in genetics and information technology. Josh Denny, MD, MS, professor of Biomedical Informatics and Medicine at Vanderbilt and VUMC’s Vice President for Personalized Medicine, has been involved in planning All of Us for more than three years.
In July 2016 VUMC was selected to lead the program’s Data and Research Center, with Denny serving as the center’s director.
Enrollment centers across the country are responsible for collecting participant data. The Data and Research Center is responsible for storing, organizing and providing secure access to the dataset in a format useful to researchers around the world.
For more than a decade VUMC has collected DNA from individuals linked to their EHRs to enable studies of genetic contributions to disease and why people vary in their response to medications. The records are scrubbed of personal identifiers to preserve patients’ privacy. All of Us will use similar procedures.
“Security is Job One,” Denny said. “No system is perfect, but all the data are tightly controlled and the system is continually tested to make sure it is secure. We are working with internal and external security experts to secure and test the system.”
Working with Verily, the life science subsidiary of Google’s parent company, Alphabet Inc., the Broad Institute of MIT and Harvard, VUMC developed processes for collecting, organizing and sharing big data securely. Prior to the national launch, more than 27,000 participants have shared health data during a nearly yearlong beta test.
In addition to assuring security and privacy, the Data and Research Center is focused on accelerating innovative research.
“We want to leverage modern data science techniques so leading computer scientists can leverage machine learning and natural language processing, the things that are in vogue in computer science, and apply those to health and make health better,” Denny said.
Researchers from academic medical centers as well as the pharmaceutical, computer science and biotech industries will be able to request access to data collected through All of Us to answer scientific questions.
Independent “citizen-scientists” are also welcome. “I’d love to see teams of high school students coming in on this resource,” he added. “They’d bring fresh ideas, learn a ton and certainly contribute.”
The essential ingredient to the program’s success is the volunteer.
“We’re seeking adults of all ages, races, ethnicities, sexual orientations, socioeconomic and health statuses to join us in this unprecedented effort,” said Dara Richardson-Heron, MD, chief engagement officer for the All of Us Research Program, who participated in a simulcast of the national launch with Collins from New York City.
“We’re seeking people from every corner of the United States because we know only too well that where a person lives has the potential to have an enormous impact on their overall health,” said Richardson-Heron, a breast cancer survivor.
“We must make sure that all communities are well represented in our program, particularly those who have been historically under-represented in biomedical research,” she added. “Health disparities are well known but not at all well understood. Research has the potential to be a powerful change agent in that regard.”
Studying diverse populations may lead to discoveries that benefit everyone. “The most recent cholesterol drugs that have come on the market were discovered in African-ancestry populations,” Denny said. “We have discovered certain (cancer) risks and why drugs work or don’t work in other populations.”
During Sunday’s simulcast, Eric Dishman, the former Intel executive who directs All of Us, described how he battled a rare form of kidney cancer for years before genetic testing enabled his doctors to find the precise therapy that led to remission and a kidney transplant.
“That’s the power of precision medicine,” Dishman said. “But the sad truth is, stories like mine are still very rare. Far too many people are still getting trial-and-error treatments for most conditions and diseases that are based on the average patient. But none of us are average.
“That’s what joining the All of Us research program is about,” he said. “Being part of the power of 1 million diverse people coming together from across the country to create a future… so you too have treatments that are designed for a unique you.
“It is the highest honor to lead and build this national treasure,” Dishman said. “Powered by the volunteerism of 1 million or more people, the impacts of this public resource will not go down only in the medical books, but also, I believe, in the history books.”
Metro Nashville Mayor David Briley and U.S. Rep. Jim Cooper, D-Tennessee, delivered the opening remarks at Nashville’s launch event.
“We’re being asked today to volunteer,” Cooper said. “That should not be hard for Tennesseans because we live in the Volunteer State.
“This is good for us,” he said. “It’s really good for our kids and grandkids. This is easily within our reach if we choose to volunteer in enough numbers. All it takes is signing up. I’m going to lead by example. I’m signing up.”
