The White House has released its plan to create and manage a database containing the medical records of 1 million or more Americans.
It will enable clinical trials of targeted therapies and use data from mobile health devices “to correlate activity, physiologic measures and environmental exposures with health outcomes."
Plans for the database are outlined in a 107-page report The Precision Medicine Initiative Cohort Program—Building a Research Foundation for 21st Century Medicine.
"We live in an incredibly exciting time for biomedical research," National Institutes of Health Director Dr. Francis Collins said at a news conference announcing the report's release. With the near ubiquitous use of electronic health records and declining costs for genetic sequencing, "The stars are aligning, now is the time for us to take bold action," he said.
The data will be available to patients, providers and other contributors, with “an initial set of analysis, visualization and dashboard tools” offered to them “as soon as possible,” the report said.
“Participants will be partners in research, not subjects, and will have access to a wide range of study results,” Collins said in a separate statement released with the report.
The feedback should help attract participants to the study, said Kathy Hudson, deputy director for science, outreach and policy at the NIH.
NIH organizers also hope "to tap into a strong thread of altruism” from people who “want to see health and medicine advance,” Hudson said.
President Barack Obama unveiled his precision medicine initiative in his State of the Union Address in January. He followed up with a gathering of healthcare industry leaders to lay out a plan to promote medical treatment tailored to individuals.
The president earmarked $130 million for this project for fiscal 2016. Appropriations legislation in both houses of Congress support the project, according to Collins.
"We're pretty optimistic" that Congress wants this, he said.
Collins admits the agency will “initially, not have the funds to do whole genomic sequencing on a million people." That would cost an estimated $2 billion at today's prices, he added. But increased demand for genomic testing because of the initiative could spike competition and lower prices.
The report says the initiative hopes to replicate developments like targeted treatments for cancer and cystic fibrosis that are effective in patients who share an underlying causal genotype.
Genetic profiles are also being used to prevent patients' adverse drug reactions, the report said.
The initiative will recruit volunteers who undergo a baseline health exam, provide a biospecimen, agree to share their electronic medical records and agree to be re-contacted by the program.
“With robust implementation,” the report suggests the database could recruit 1 million volunteers “over about four years,” but recruiting should continue and the size of the group should grow.
The plan also calls for a “core data set” to be stored in a central location, with standardized consent forms used for all patient participants “to ensure consistency in terms and conditions that all PMI cohort participants agree to.”
The report states there will be measures taken to ensure data is safe and private.
Human subjects participating in the Precision Medicine Initiative can expect to be protected by federal rules released earlier this month. Updates on the Common Rule, as it is known, included clearer consent for the reuse of stored blood or tissue in new research unrelated to their original use.
A search will commence soon for a project leader, Collins said, but meanwhile he named Dr. Josephine Briggs, director of the National Center for Complementary and Integrative Health at the NIH, as interim director.