WASHINGTON -- President Obama's precision medicine initiative (PMI) is moving forward on several fronts, according to Obama administration officials.
"There are too many diseases without effective treatments or options, too many conditions remain undiagnosed, and many prevention approaches used today are not tailored to individuals' lifestyles, genes, or preferences," said , assistant to the president and deputy chief of staff for implementation, on a Wednesday afternoon conference call with reporters. "Obama launched the PMI last year with the vision that we can successfully improve health and better understand how to prevent and treat diseases ... We're treating precision medicine as a whole-of-government effort."
On the patient-involvement front, the National Institutes of Health (NIH) is to help sign up veterans to provide health data and biological specimens that researchers will use to map patients' genomes and create a database of information to help develop precision medicine treatments.
"The VA has had a head start on precision medicine research," Canegallo said. "Five years ago, they began the to address health questions key to vets; the VA is already ... putting into place a technology platform to enable cutting-edge research."
Although the NIH is hoping to enroll some of its 1 million or more database patients through the VA, it is also proceeding with other recruitment efforts, NIH director , explained on the call. "We are excited to announce a set of awards to make it possible for NIH to begin enrollment in the PMI cohort later this year," he said.
The NIH to set up the PMI infrastructure and start recruiting patients. Award recipients include:
- A total of four regional medical centers -- one each in New York City, Chicago, Pittsburgh, and Tucson, Ariz. -- at which patients will be recruited;
- A total of six federally qualified health centers -- one each in Knoxville, Tenn.; Middletown, Conn.; Columbia, S.C.; Peekskill, N.Y.; Jackson, Miss.; and San Ysidro, Calif. -- which also will recruit patients;
- Scripps Research Institute, in San Diego, and Vibrent Health, in Fairfax, Va. -- the two organizations will set up a Participant Technologies Center to help patients enroll directly in the PMI through mobile apps and other means; and
- Vanderbilt University Medical Center, in Nashville, Tenn., which is setting up and organizing access to the PMI database
In addition, in May the NIH designated the Mayo Clinic in Rochester, Minn. as the institution that would operate the "biobank" that will collect and store data generated from the PMI.
During a question-and-answer session, Collins said he wasn't sure how long it would take to sign up 1 million participants. "We don't have specific numbers for each of the sites; we're aiming to achieve in the first year on the order of 10,000 individuals per site, and then [have] the direct volunteer effort to allow anybody in the U.S. to raise their hands and enroll," he said. "We don't anticipate having a million signed up for another 3 to 4 years."
The PMI will differ from other large research efforts in several respects, according to Collins: "First, participants in the program will be true partners -- not subjects, not patients -- and will be involved in every step ... including what data to collect, what analyses to do in the lab, and what data should be returned to them. Second, the cohort will represent the rich diversity of America, engaging volunteers of all economic levels to produce meaningful health outcomes for all races, ethnicities, and communities. Third, data-sharing will be swift to both researchers and participants. Participants will have access to study information and data about themselves."
On the regulatory front, FDA commissioner , discussed that were related to the PMI, both dealing with the next-generation sequencing (NGS) tests that will be used to analyze patients' genomic specimens. "The development and growth of next-generation sequencing is pivotal to the growth of the PMI initiative," he said. "It's the FDA's responsibility to ensure that doctors and patients can depend upon the accuracy and reliability of these tests."
One draft guidance addresses how accurately a test should be able to identify a genetic variant, while the other addresses the use of genetic databases to determine that a particular test is clinically valid in predicting a disease or condition. "Taken together, these guidances will foster innovation, assure the quality and reliability of NGS-based tests, and promote their adoption in clinical practice," Califf said.
As the teleconference ended, Califf urged reporters to sign themselves up for the project once it begins enrolling patients. "I'll be very disappointed if you don't," he said.