The National Institutes of Health has announced $55 million in awards in the 2016 fiscal year needed to launch the Cohort Program of President Obama's Precision Medicine Initiative.
The PMI Cohort Program is a longitudinal research effort that aims to engage 1 million or more participants to improve the ability to prevent and treat disease based on individual differences in lifestyle, environment and genetics. The awards will enable the foundational partnerships and infrastructure that will support a data and research support center, participant technologies center and a network of healthcare provider organizations.
An award to Mayo Clinic in Rochester, Minnesota, to build the PMI Cohort Program Biobank -- another essential component -- was announced in May of 2016. The biobank will support the collection, analyses, storage and distribution of biospecimens. Data from laboratory analyses of biospecimens will be combined with an assemblage of other lifestyle and health information provided by volunteers to help researchers continue to unravel individual differences that contribute to disease and response to treatments.
All awards are for five years, pending progress reviews and availability of funds. With these awards, NIH is on course to begin initial enrollment into the PMI Cohort Program in 2016, with the aim of meeting its enrollment goal by 2020.
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The NIH expects the PMI Cohort Program will set the foundation for new ways of engaging people in research. PMI volunteers will be asked to contribute a wide range of health, environmental and lifestyle information. They'll also be invited to answer questions about their health history and status, share their genomic and other biological information through simple blood and urine tests and grant access to their clinical data from electronic health records.
In addition, mobile health devices and apps will provide lifestyle data and environmental exposures in real time. All of this is expected to be accomplished with essential privacy and security safeguards in place. As partners in the research, participants will have ongoing input into study design and implementation, as well as access to a wide range of their individual and aggregated study results.
The NIH anticipates that the knowledge gained from the PMI Cohort Program will extend successes of precision medicine in some cancers to a number of other diseases. The program will focus not just on disease, but also on ways to increase an individual's chances of remaining healthy throughout life.
These initial awards bring together the major elements through a variety of new partnerships that NIH said are needed to launch the PMI Cohort Program later this year; NIH Deputy Director for Science, Outreach, and Policy Kathy Hudson, Ph.D., who helped orchestrate the PMI Cohort Program, said in a statement that "This is an incredibly complex study requiring new kinds of strategic and operational partnerships -- this can't be business as usual."
"This range of information at the scale of 1 million people from all walks of life will be an unprecedented resource for researchers working to understand all of the factors that influence health and disease," said NIH Director Francis Collins, M.D., Ph.D., in a statement. "Over time, data provided by participants will help us answer important health questions, such as why some people with elevated genetic and environmental risk factors for disease still manage to maintain good health, and how people suffering from a chronic illness can maintain the highest possible quality of life. The more we understand about individual differences, the better able we will be to effectively prevent and treat illness."
The infrastructure will be assembled with a number of organizations, and is intended to expand over time as needed. The Data and Research Support Center has been awarded to Vanderbilt University Medical Center in Nashville, Tennessee; it will work with the Broad Institute in Cambridge, Massachusetts and Verily Life Sciences (formerly Google Life Sciences) in Mountain View, California. This center will acquire, organize and provide secure access to large and diverse datasets for precision medicine research. They will also provide research support for the scientific data and analysis tools for the program, helping to build a network of researchers from community colleges to top healthcare research institutions and industries; the network will include citizen scientists, who can propose studies using this information.
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Enrollment of PMI Cohort Program participants, meanwhile, will be through two distinct approaches. One leverages the strengths of HPOs that have existing relationships with potential participants, and the other will be through the Participant Technologies Center, which will support direct enrollment. The Participant Technologies Center has been awarded to the Scripps Research Institute in San Diego, and Vibrent Health in Fairfax, Virginia. The center will also develop, test, maintain and upgrade PMI Cohort Program mobile applications as needed. These mobile apps will be used to enroll, consent with, collect data from and communicate with PMI Cohort Program participants.
The center, according to NIH, will need to develop parallel platforms to deliver these same functions to those without smartphones, and work with various technology organizations to increase smartphone accessibility.
NIH will build a network of HPOs over time to ensure that participants in the research represent the geographic, ethnic, racial and socioeconomic diversity of the country. The network will include regional and national medical centers, community health centers and medical centers operated by the U.S. Department of Veteran Affairs. The regional medical centers that have been selected as the initial set of HPOs, with another funding opportunity in the coming months, are Columbia University Health Sciences in New York City, Northwestern University in Chicago, University of Arizona in Tucson, and University of Pittsburgh at Pittsburgh.
These HPOs will engage their patients in the PMI Cohort Program, help build the research protocols and plans, enroll interested individuals and collect essential health data and biological specimens.
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These awardees have sub-awards with organizations that extend the geographic reach of the HPO network. In addition, NIH collaborated with the Health Resources and Services Administration to select six federally qualified health centers, which are community-based HPOs that reach underserved areas and populations. This award supports a pilot program to determine infrastructure needs that will enable a wide variety of FQHCs to participate as HPOs. FQHCs, according to NIH, will be critical for bringing underserved individuals, families and communities into the cohort, especially those historically underrepresented in biomedical research. The recipients are Cherokee Health Systems in Knoxville, Tennessee; Community Health Center in Middletown, Connecticut; Eau Claire Cooperative Health Center in Columbia, South Carolina; HRHCare in Peekskill, New York; Jackson-Hinds Comprehensive Health Center in Jackson, Mississippi; and San Ysidro Health Center in San Ysidro, California.
Another partner considered noteworthy in the HPO network is the VA; by collaborating with them, the NIH hopes to ensure America's former servicemen and women have the opportunity to participate in the PMI Cohort Program. The VA will leverage the experience and infrastructure gained from its Million Veteran Program -- which partners with U.S. veterans receiving care at VA medical centers -- to study how genes affect health, and help enroll veterans in the PMI Cohort Program.
Twitter: @JELagasse