- The first beta test participants in the All of Us Research Program have started to contribute their personal health data to the nation-wide precision medicine program, says Director Eric Dishman.
The program, previously known as the PMI Cohort, aims to collect genomic, clinical, and lifestyle data from at least one million participants over the next few years, although the beta test will initially focus on just 10,000 people.
“This is a major milestone in our progress to date, and one of many more to come for our startup research consortium that came together less than a year ago,” Dishman wrote in a National Institutes of Health (NIH) blog post.
“As with every aspect of the program, we’re starting small with enrollment and scaling up carefully as we go, beginning with one site and gradually expanding to more than 100 sites nationally during the beta phase.”
Throughout the summer and into the early fall, new sites will be added according to a staggered schedule, he added. Each location will recruit a few participants at a time, building up to larger volumes once they have worked out any kinks in the process.
All of Us has been billed as the centerpiece of the national Precision Medicine Initiative: a rich and accessible genomic biobank with the added benefit of longitudinal clinical, socioeconomic, and behavioral data from highly engaged participants.
The recent name change was intended to promote the idea of ongoing patient commitment to the initiative and a dataset that includes representatives from social, ethnic, and racial groups reflecting the real-life makeup of the United States.
“By providing information about their health, lifestyles, and environments over the course of many decades, these volunteers will be important partners in helping create an unprecedented research resource to drive future discoveries,” the blog post says.
“This resource will be easily accessible to researchers of all kinds, from citizen scientists to investigators in academia and industry, for studies on a variety of health topics.”
Recruiting a broad range of participants will not be a simple task, however. While potential contributors seem eager to share their personal information with researchers, the NIH will need to develop organic, engaging, and easily comprehensible methods for educating individuals about the program.
In order to achieve these goals, the NIH has conducted preliminary pilots at a number of sites. Early partners include healthcare systems and academic institutions such as the Department of Veterans Affaris, Cedars-Sinai, Banner Health, Partners Healthcare, Northwestern University, the University of Arizona, and members of the University of California system.
“We’ve developed a research protocol, including an initial set of surveys. We’ve invested in a state-of-the-art biobank and built ‘big data’ IT systems to transfer and store data, with safeguards in place to keep participants’ information private and secure,” Dishman explained.
“And we’ve reached out for feedback from dozens of organizations and issued a funding opportunity to support engagement efforts with community partners large and small.”
Expanding the beta test will allow researchers to continue to iron out any issues with enrollment or participant education and commitment to the initiative, he continued.
“Our beta testers will help us find problems with our systems and processes, so we can fix them and improve the experience for everyone going forward. And most importantly, they will help us evaluate and improve our messaging, our engagement approaches, and our relationship building with diverse communities across the country.”
Once this phase of the project is complete, the team will pause to assess the results and make any necessary adjustments.
By the end of 2017 or beginning of 2018, the NIH expects to be able to expand the program to numerous new partners and enrollment sites across the country.
“Ultimately, we want to build a community at least one million strong, with participants from all walks of life and parts of the country,” said Dishman.
“As excited as we are about entering this next phase of the program, we also recognize that this is just the beginning. All along, our mantra has been that we’ll “launch when ready and right.” Beta testing is a critical step to getting there. I’ll keep you posted!”