I recently spoke with Dara Richardson-Heron M.D., chief engagement officer of the All of Us Research Program (@AllofUsResearch) at the National Institutes of Health. Dara is leading efforts to engage a million volunteers or more from diverse communities across the country in building one of the largest biomedical datasets in the world, and is seeking to reach out to populations historically underrepresented in research. Everyone in the U.S. is invited to join the All of Us cohort. Researchers are invited to participate in the project as well.
As she describes it, the All of Us research program has “a simple mission and that is to accelerate health research and medical breakthroughs and in order to reach this goal we’re asking one million or more people to share their health information to inform future health studies.” The inputs will be EHRs, health surveys, physical measurements, blood and urine samples, DNA samples. “And in the future, approved researchers, including community or citizen scientists, we hope will use this data to conduct many types of studies with the hopes of finding patterns in the data to better prevent, diagnose, and treat disease for individuals and in turn we’re going to return and responsibly return information back to participants so that they can learn more about themselves and their families [and] enhance their own health.”
As conceptualized, the All of Us study sounds like it’s a combination of the VA’s Million Veterans genomic study and the Framingham study – gathering a variety of data types over time – everything from socioeconomic data, to lifestyle data, to environmental data, to health record data, to genomic data gathered through biobanking and sequencing, to data collected through questionnaires, with a goal of creating a dataset drawn from a diverse population base, over the course of up to ten years, supercharged by the notion of making data and data analysis tools available to community- and citizen-scientists as well as the usual suspects – in order “to have better health and healthcare for everyone … because we know that it’s the actual bringing together of all of these major factors that impacts health and wellness and disease.”
In addition to the diversity of data types to be collected, Dara emphasized that a key differentiator of the All of Us program is intended to be the diversity of study participants: that “We’re talking demographically, geographically, medically and especially those who are underrepresented in biomedical research.” As we know, “when you don’t have data and input from a wide variety of people you can’t get the full picture of health in the United States … we really need participation from people that reflect the diversity of America. And prior research studies we have not seen that and we really are expecting our program to be a game changer in that regard.”
By “focus[ing] on participants as partners in our programs … we really want participants to be involved in the governance, we want them to invent systems, and provide input into the science, and have a choice in how they get their data back and information back from our program.” Dara also expressed the program’s commitment to creating a national open resource – “open … to the public, and researchers of course, with appropriate safeguards, and open source software and tools so that [we can share] medical breakthroughs.”
We also discussed the challenges of interoperability and security in the context of the program’s plan to integrate participant data from multiple resources and then share it with multiple researchers. Dara conveyed a commitment to making things work smoothly and to protecting participant data, while acknowledging that there can be no guarantee that breaches will not occur.
The All of Us program includes patients on its steering committee and on an advisory panel. I asked Dara if the program intended to compensate patients for the use of their data, and she said that she hoped that people would participate out of altruism and also the potential for benefits for themselves and their family members based on the outcomes of the project.
As an example of a condition that could be helped by the project, Dara identified Alzheimer’s Disease, noting that it is the sixth leading cause of death in the US, and that the costs – both emotional and financial – are enormous. She continued: “Hopefully our longitudinal data will provide the opportunity to observe the progress of aging and enrich social environmental and biological data. And we may be able to understand the causes and, more importantly, … identify ways to prevent it…. [W]hat we’re creating is a database for researchers of all kinds to come in and really help us get to some of the answers that we have not yet had in the healthcare field. And we hope to democratize research in a way such that you don’t have to be connected to a major research institution to be able to access this data.” And the focus is not limited to one disease, it will be determined by researchers who access the data and use it to address other chronic and acute illnesses. In fact, the research community has been engaged to help the program determine what data to collect – data that will be useful to researchers in their work, which may include the development of diagnostic and other algorithms through the use of machine learning in analyzing the data developed by the program.
In closing, Dara answered my question about what she would hope or expect to be different in five years by saying: “ I would hope and expect in fact that in five years — due in large part to the incredible success of the All of Us research program — that the physicians, researchers, health information technology professionals, pharma, and other key stakeholders in the healthcare profession, will hopefully have aligned strategically and cooperatively to foster the creation of the scientific evidence, the infrastructure — and most importantly, the ecosystem — to begin to identify opportunities to prevent disease in the first place.” In addition, “for illnesses that do occur in the five year timeframe I’m hoping that key stakeholders will have made great progress in uncovering the paths to delivering the right treatment to the right person at the right time based on their lifestyle, environment and biology, thereby decreasing health disparities and significantly decreasing the burden of disease …for all of us.”
I spoke with Dara as part of my ongoing series of fireside chats with healthcare innovation leaders – Harlow on Healthcare, on HealthcareNOW Radio. Listen to our radio station online, or ask your smart speaker (Amazon Echo or Google Home): “Find Tune In station HealthcareNOW Radio.” You can catch me live weekdays at 8:30 am, 4:30 pm and 12:30 am ET. As each new show goes live, the last one joins the archive, available via SoundCloud or your favorite podcast app (iTunes, Stitcher, iHeartRadio). Your comments are welcome here. Join the conversation on Twitter at #HarlowOnHC.
David Harlow
The Harlow Group LLC
Health Care Law and Consulting
I work for http://www.overlaphealth.com and this is my personal opinion.
I think Dara’s perspective is critical. I wonder though how much of these data sets will be available for researchers in the coming years. One idea I’ve had for years now is having a Github like resource for data sets produced by these kinda of digital health research that’s searchable by disease domain or data type.
Anyway, thanks for the insightful article. I’m rooting for the All of Us program’s success.