The National Institutes of Health (NIH) announced $55 million in awards in fiscal year 2016 to build the foundational partnerships and infrastructure needed to launch the Cohort Program of President Obama’s Precision Medicine Initiative (PMI). The PMI Cohort Program is a landmark longitudinal research effort that aims to engage 1 million or more US participants to improve our ability to prevent and treat disease based on individual differences in lifestyle, environment and genetics.
The awards will support a Data and Research Support Center, Participant Technologies Center and a network of Healthcare Provider Organizations (HPO). An award to Mayo Clinic, Rochester, Minnesota, to build the biobank, another essential component, was announced earlier this year. 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.
The PMI Cohort Program is one of the most ambitious research projects in history and will set the foundation for new ways of engaging people in research. PMI volunteers will be asked to contribute a wide range of health, environment and lifestyle information. They will 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 will be accomplished with essential privacy and security safeguards. 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.
“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 S. Collins, M.D., Ph.D. “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 knowledge gained from the PMI Cohort Program will extend successes of precision medicine in some cancers to many other diseases. Importantly, the program will focus not just on disease, but also on ways to increase an individual’s chances of remaining healthy throughout life.
“As someone who has personally benefited from precision medicine, I am excited for this study to intersect with other fundamental changes in medicine and research to empower people to live healthier lives,” added PMI Cohort Program Director Eric Dishman. “What potential participants need to know is that we are equally interested in learning how we can prevent illness in the first place, but when we do get ill, which treatment options are going to work best for each of us individually.”
These initial awards bring together the major elements through a variety of new partnerships that are needed to launch the PMI Cohort Program later this year. “This is an incredibly complex study requiring new kinds of strategic and operational partnerships — this can’t be business as usual,” said Kathy L. Hudson, Ph.D., NIH Deputy Director for Science, Outreach, and Policy who helped orchestrate the PMI Cohort Program. “We are excited to break new ground in engaging people in research and building a study of this scale and scope.”
The infrastructure will be assembled with the following organizations and is intended to expand over time as needed to support the growth of the cohort:
The Data and Research Support Center has been awarded to Vanderbilt University Medical Center, Nashville, Tennessee, working with the Broad Institute, Cambridge, Massachusetts, and Verily Life Sciences (formerly Google Life Sciences), Mountain View, California. This center will acquire, organize and provide secure access to what will be one of the world’s largest and most 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 vibrant community of researchers from community colleges to top healthcare research institutions and industries, and including citizen scientists, who can propose studies using this information.
Enrollment of PMI Cohort Program participants 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, San Diego, and Vibrent Health, Fairfax, Virginia. The center will also develop, test, maintain and upgrade, as needed, PMI Cohort Program mobile applications. These mobile apps will be used to enroll, consent, collect data from and communicate with PMI Cohort Program participants. Importantly, the center 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 US Department of Veteran Affairs (VA). The following organizations have been selected as the initial set of HPOs with another funding opportunity in the coming months. 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. The regional medical centers are: Columbia University Health Sciences, New York City, Northwestern University, Chicago, University of Arizona, Tucson, University of Pittsburgh at Pittsburgh.
These awardees have sub-awards with organizations that extend the geographic reach of the HPO network. In addition, NIH collaborated with the Health Resources & Services Administration (HRSA) to select six Federally Qualified Health Centers (FQHCs), 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 will be critical for bringing underserved individuals, families and communities into the cohort, especially those historically underrepresented in biomedical research. Recipients are:
Cherokee Health Systems, Knoxville, Tennessee
Community Health Center, Inc., Middletown, Connecticut
Eau Claire Cooperative Health Center, Columbia, South Carolina
HRHCare, Peekskill, New York
Jackson-Hinds Comprehensive Health Center, Jackson, Mississippi
San Ysidro Health Center, San Ysidro, California
Another significant and important partner in the HPO network is the VA, which has medical centers across the United States that provide care to America’s veterans. By collaborating with the VA, the NIH will ensure America’s former servicemen and women have the opportunity to participate in the PMI Cohort Program. The VA Healthcare System serves a demographically and geographically diverse population, which strengthens NIH’s capacity to enroll people of all races and socioeconomic backgrounds in the cohort. 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, to help enroll veterans in the PMI Cohort Program.
In May of 2016, Mayo Clinic was awarded the task of building the PMI Cohort Program Biobank. The biobank will support the collection, analyses, storage and distribution for research use of biological samples known as biospecimens. Data from laboratory analyses of biospecimens will be combined with an array 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.