On Sunday, May 6, Vanderbilt University Medical Center (VUMC) participated in the national launch of the National Institutes of Health’s All of Us Research Program, a momentous effort to advance individualized prevention, treatment and care for people of all backgrounds.
In July 2016, VUMC was selected to lead the program’s Data and Research Center with Joshua Denny, MD, MS, professor of Biomedical Informatics and Medicine and VUMC’s Vice President for Personalized Medicine, serving as the Center’s director.
Denny has been involved in planning All of Us for more than three years.
Participants within the All of Us Research Program will consist of volunteers who, by sharing their health data, will help accelerate discoveries in understanding, treating and preventing a host of diseases.
Enrollment centers active across the U.S. are responsible for collecting participant data. While enrollment centers expand, participants can easily enroll online, using a smartphone or computer. The Data and Research Center is responsible for storing, organizing and providing secure access to the program’s data set in a format useful to researchers around the world. Security, privacy and accelerating innovative research are its driving tenets.
The goal of All of Us is to support research to better understand genetic, demographic, environmental and lifestyle factors that affect wellness. All of Us research ultimately may 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 on May 6.
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.
For more than a decade, VUMC has collected DNA from individuals and linked these samples to their electronic heath records (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., and the Broad Institute of MIT and Harvard, VUMC is developing processes for collecting, organizing and sharing big data securely. Prior to the national All of Us launch, more than 27,000 participants have shared health data during a nearly yearlong beta test.
“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.
Essential to the program’s success are its volunteers.
“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.
“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.”
Studying diverse populations may lead to discoveries that will 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.”
About the enrollment process: Participants ages 18 and older can sign up at the All of Us website, https://www.joinallofus.org, available in both English and Spanish, and will be asked to complete a series of online health surveys. They will also be asked to authorize access to their 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 also may be asked to share device information that tracks their activity level throughout the day or measures their blood pressure at home.
From all of these data, researchers will be able to glean new clues to health conditions and illnesses.