President Barack Obama’s ambitious 1-million-person personalized medicine study began to take shape this week with the announcement of four medical centers that will recruit volunteers starting this fall. A fifth center aims to sign up 350,000 participants by blasting the general public with ads coming soon to your web browser or mobile phone.
The White House’s announcement yesterday of $55 million in awards from the National Institutes of Health (NIH) fires the starting gun for the Precision Medicine Initiative (PMI) Cohort Program. The plan is to recruit 1 million or more people who are willing to share their health and genetic information over many years to help researchers develop individualized treatments. Other countries have similar studies underway, but the U.S. version aims to be larger, more diverse, and more patient-centric—participants will help shape the study and be able to see their data. NIH Director Francis Collins calls it “the largest, most ambitious research project of this sort ever undertaken.”
President Obama, who first announced the PMI in January 2015, writes today in The Boston Globe that “the ensuing breakthroughs” from the PMI study could create jobs, improve health care, and “help people live longer, happier, and healthier lives.”
To create the cohort, NIH initially expected to link up existing large health studies with DNA samples, such as a huge biobank run by the health provider Kaiser Permanente in northern California. But an advisory group recommended recruiting new volunteers partly so that data and sample collection could be standardized. NIH then invited health care providers to apply to participate.
The winners are four medical centers spread across the country: Columbia University Medical Center; Northwestern University in Chicago, Illinois; the University of Pittsburgh in Pennsylvania; and the University of Arizona, Tucson. These centers are teaming up with local health care providers to find study volunteers.
Each center will aim to enroll 10,000 participants in its first year starting in November, then 35,000 a year through 2020 to reach a total of 150,000. The $55 million in awards for the fiscal year ending on 30 September also includes funding to allow the Veterans Administration to recruit volunteers, and to help community health centers attract participants from low-income communities. More recruitment centers will be added later.
Even the newly announced centers weren’t sure how the competition would play out—several favorites aren’t on the list, some researchers note. Geneticist David Goldstein, principal investigator for the Columbia center, thinks NIH favored applicants with the ability to securely share patients’ electronic health records and enroll a diverse group of people. Until now, most participants in large genetics studies have been white. “We are really going to fix that this time,” Goldstein says, in Columbia’s case by recruiting people from neighborhoods such as Harlem.
One of the University of Arizona’s strengths is that is can draw on “a huge, diverse patient population,” notes center co-leader Elizabeth Calhoun. Its partner, Banner Health, treats patients across the Southwest, including Native Americans and many Latinos.
NIH also wants to make it possible for “anyone in the United States to be able to raise their hand” and sign up, Collins says. To that end, the largest award ($20 million the first year) goes to Scripps Research Institute in San Diego, California, and Vibrent Health in Fairfax, Virginia, to run a center that aims to enroll 350,000 volunteers directly through the web, mobile apps and a call center. Scripps principal investigator Eric Topol says his center will work with Walgreens, Apple, Blue Cross, Verizon, and other companies on notifications and apps that will point potential volunteers to a nearby enrollment site. “We have the ability to touch almost every American through these different entities,” Topol says. His center will also develop wearable devices to record participants’ health data.
The White House also announced a data center for the study run by Vanderbilt University in Nashville together with Verily (formerly Google Life Sciences) and the Broad Institute in Cambridge, Massachusetts. In May, NIH awarded a contract to the Mayo Clinic in Rochester, Minnesota, to maintain the study’s biobank of blood, urine, and other samples.
There are still many details to be worked out. Study investigators are meeting at NIH this week to hash out matters such as what information to collect on a volunteer health questionnaire. But some aren’t waiting to get started. The University of Arizona plans to open a registry in the next few weeks to compile contact information for people who are potentially interested in the study, says principal investigator Akinlolu Ojo.
Topol thinks NIH will have no trouble finding 1 million volunteers. “Just yesterday since this was announced, we've had hundreds of people contact Scripps saying they want to enroll. And we haven't even started yet,” he says.