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Biomedical Research Initiative Collecting Data From More Than 1 Million People

Analysis  |  By Christopher Cheney  
   August 15, 2019

The large sample size of The All of Us Research Program is expected to spawn big opportunities.

More than 175,000 participants have enrolled in The All of Us Research Program, which is set to have at least 1 million people enrolled over several decades.

Collecting data—such as biospecimens, health questionnaires, and electronic health records—from 1 million people will create a sample size capable of generating studies that account for individual differences in lifestyle, socioeconomic factors, environment, and biologic characteristics. The data repository has the potential to boost precision diagnosis, prevention, and treatment.

"Advances in genomics and biosensors have set the stage for refined taxonomies of disease, which may help to guide prognosis, improve existing treatments, and aid in the development of new therapies. Most important, advances in genomic analyses have helped to identify the underlying causes of disease in individual patients. However, many efforts have been hampered by an inadequate sample size and a lack of diversity among participants," All of Us researchers wrote this week in the New England Journal of Medicine.

The All of Us program received funding from the National Institutes of Health in 2016 and began enrolling participants in 2018. As of July 2019, biospecimens had been collected from 175,000 people.

The research program is designed to collect data from underrepresented groups. So far, more than 80% of participants are from groups that have been underrepresented in biomedical research.

Enrolling 1 million people will help address the dearth of diversity in research repositories and promote precision medicine, the corresponding author of the New England Journal of Medicine article told HealthLeaders.

"The paradox of precision medicine, to better treat the individual, is it takes large populations to better understand what is happening at the individual level.  It is especially important that we capture diversity—about one-third of the United States is African American, Hispanic, or Native American, but only about 3% of existing genome-wide association studies cover these populations. It is important to capture this diversity and explore," said Joshua Denny, MD, a professor of medicine and biomedical informatics at Vanderbilt University Medical Center.

The All of Us initiative will improve understanding of health and disease in two primary ways, he said. "By revolutionizing how we improve health and treat disease—moving beyond 'one-size-fits-all' healthcare designed for the 'average' patient, and by ensuring that healthcare is tailored to the things that make us unique—our lifestyle, environment, and genes."

Denny expects the initiative will generate thousands of medical research projects.

Following initiative participant health and outcomes over decades

Participation in the All of Us program is guided by several features:

  • After granting consent, program participants complete baseline health and demographic surveys
  • Program participants grant access and sharing rights to electronic health record (EHR) data
  • Program participants provide biospecimens and physical measurements
  • Program participants can provide Fitbit data to the All of Us program, which plans to include data from other monitoring devices
  • Other data collected from program participants includes billing codes, laboratory and medication data, and narrative content

"With a plan to follow the health and outcomes of participants over decades, the All of Us program should enable research that provides an improved understanding of health and disease, which in turn would support accurate diagnoses, rational disease-prevention strategies, treatment selection, and the development of targeted therapies," the researchers wrote in NEJM.

The bounty of data is expected to generate groundbreaking opportunities, they wrote. "Our hope is that identification of risk factors and biomarkers—including environmental exposures, habits, and social determinants—will improve population health by bringing about more efficient and accurate diagnosis and screening, better understanding of diverse populations, more rational use of existing therapeutics, and the development of new treatments."

Christopher Cheney is the CMO editor at HealthLeaders.


The All of Us Research Program is collecting data across a broad population, including people who have been underrepresented in previous biomedical research.

So far, 175,000 people have enrolled in the research program.

The research program has the potential to boost precision diagnosis, prevention, and treatment.

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