An ambitious plan to recruit 1 million U.S. volunteers and amass a treasure trove of their health information will start next week with a “beta test” that health officials hope to eventually expand nationwide.
National Institutes of Health director Francis Collins said Wednesday that the Precision Medicine Initiative will begin in Pittsburgh, where the agency aims to enroll up to 15,000 participants by the end of summer. It’s the start of a plan whose seeds were planted more than two years ago, when former President Barack Obama proposed a study to glean insights about health and disease by tracking a large group of people over decades.
Originally called the Precision Medicine Initiative, or PMI, its name was recently changed to “All of Us.” Collins, speaking at Duke University during the Precision Medicine World Conference, said the name change better conveys that the medical questions the initiative is trying to answer will help everyone.
“We hope all of these people are healthy, and we want to figure out how to keep them healthy,” he said.
The financial support for All of Us is still uncertain. Earlier this month, when Congress reached a plan to fund the federal government through the remainder of the fiscal year, lawmakers gave the NIH, which will finance the initiative, a budget boost. But the 2018 budget plan proposed by the Trump administration includes deep funding cuts to the NIH. It’s unclear if those cuts will hold when the budget ultimately makes its way through Congress, but even if things change, some NIH officials reportedly fear that the Trump administration will propose other ways to cut back NIH spending.
Collins said that All of Us will draw most of its financial support from the 21st Century Cures Act, a wide-ranging law that aims bolster biomedical research and also speed up the development and approval of new drugs and medical devices. The legislation, which earmarked $4.8 billion in financial support for the NIH, received bipartisan support in Congress last year. Collins said that under that law, All of Us is authorized to receive $1.5 billion over 10 years. He described the funds as “no-year money,” meaning that they can be spent now or later, giving the NIH flexibility. But Collins hopes that enrollment won’t take 10 years. His goal is to reach the 1 million volunteer mark by the end of 2022.
There is precedent for using long-term studies for health research. Duke University has a target enrollment of 50,000 participants for its MURDOCK study tracking the health of volunteers living in Kannapolis, NC. The best known longitudinal study might be the Framingham Heart Study, which started in 1948 by tracking the cardiovascular health of 5,000 volunteers from Framingham, MA, a town outside of Boston. Collins hopes to learn from Framingham, which is currently studying its third generation of participants. Besides the difficulty of recruiting volunteers, he said such studies also face challenges retaining them.
Technological advances make the timing right for a national prospective study tracking the health of a large group of Americans, Collins said. Electronic health records, smartphones, and wearable devices provide new ways for researchers to capture data. Also, sequencing a human genome is now faster and more affordable than it was a decade ago. But despite the steep drop in the cost of conducting genomic research, All of Us won’t have enough funding to sequence the genomes of all participants. Collins said the study will start with chip genotyping, a way of studying genetic variation without doing whole genome sequencing. The study will do some sequencing, but not for all participants.
The NIH is taking steps to make sure that All of Us captures a broad representation of the U.S. population. In Pittsburgh, the NIH is working with the University of Pittsburgh to recruit participants. The study will include children, though Collins said that they won’t be enrolled until next year. By then, he expects that the NIH will have worked out how to handle parental consent. To diversify the pool, the initiative is also working with federally funded qualified health centers that serve patients who might not typically be involved in longitudinal research. Collins added that it is important that the study include veterans.
As All of Us marches toward its goal of 1 million participants, it will build connections with other organizations. Collins noted that Anne Wojcicki, CEO of genetic testing company 23andMe, is an advisor to All of Us. Though 23andMe has different goals, Collins said that the Mountain View, CA, startup’s approach to reaching potential users was instructive to the NIH.
“We’ve learned a lot…from 23andMe, just the ability to interact with people,” he said.