‘All of Us’ Begins Nationwide Enrollment
Exactly 2 months shy of the second anniversary of its founding on July 6, 2016, the All of Us Research Program (formerly known as the Precision Medicine Initiative Cohort Program) opened enrollment nationwide on May 6. The event was marked by community events in seven cities across the country.
The program intends to partner with 1 million or more people across the United States who will share information over time to help build the world’s largest and most diverse data resources for health research. Initially, enrollees will have to be 18 or older, but the program hopes to begin accepting children in summer 2019.
“This might have seemed like a pipe dream 15 years ago, but today it is a reality,” said NIH director Dr. Francis Collins at a May 1 media telebriefing. He called All of Us a historic, unprecedented and unique program that will last at least a decade if not longer.
“This will be a massive public resource,” he said. “It is among the most ambitious research efforts our nation has ever undertaken…The possibilities are pretty limitless.”
Eric Dishman, director of All of Us, said the program “is incredibly personal to me.” Diagnosed with a rare kidney cancer, he underwent 23 years of treatment and endured 57 rounds of “imprecise medicine” before benefiting from cutting-edge therapy. “It ought to be personal to you, too.”
He expects the program will reach its goal of 1 million participant/partners in 5-6 years, “but if 10 million sign up on May 6, we’d be very happy.”
Researchers of all kinds, including citizen scientists, will be able to request access to All of Us information to conduct studies to inform how individual differences affect health and disease. The research portal is expected to open in 2019, Dishman said.
“We won’t wait until the end of the study to make data available—we want to let thousands of flowers bloom.” Findings from these studies may lead to more tailored health care approaches in the future.
Enrollees may provide physical measurements including blood pressure, body mass index, heart rate, height, hip circumference, waist circumference and weight. Biosamples to be collected include blood (or saliva if blood draw is unsuccessful) and urine.
In the past 2 years, All of Us has reached the following milestones:
- Version 1 protocol tested and Institutional Review Board-approved; a beta phase is already well under way
- Built network of 100+ academic, provider, technology and community partners
- Established partnerships with 25 community, provider, advocacy organizations and the National Library of Medicine to help educate and engage diverse populations
- Developed participant-friendly and bilingual (English and Spanish) enrollment website, participant portal and call center
- Constructed biobank building/robotic capability with 24-hour shipping process; currently storing more than 800,000 frozen vials with capacity for more than 35 million vials
- Developed data warehouse with infrastructure to collect, clean, curate, de-identify and eventually share the data
- Completed end-to-end security & usability testing; obtained Authority to Operate
- Developed innovative pilots for testing EHR (electronic health record) & wearables strategies (Fitbit pilot)
- Launched 129 clinics across the country to begin enrolling participants, with “pop-up” clinics planned for distant areas
- Already, more than 45,000 participants started protocol; more than 27,000 completed all available protocol.
Those interested in joining the program can do so by visiting, www.JoinAllofUs.org.