In one of the most ambitious research projects in history, the National Institutes of Health is giving select healthcare organizations $55 million in awards in fiscal year 2016 to launch the Cohort Program of President Barack Obama's Precision Medicine Initiative.
The PMI Cohort Program is a pioneering longitudinal research effort that aims to engage 1 million or more U.S. participants to improve scientists' and healthcare providers' 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.
"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, MD, PhD. "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."
Here are seven things to know about the PMI Cohort Program and the NIH awards.
1. All NIH awards are for five years, pending progress reviews and availability of funds. The NIH is on track to begin initial enrollment in the program in 2016, with the aim of meeting its enrollment goal of 1 million people by 2020.
2. Rochester, Minn.-based Mayo Clinic earned the award earlier this year to build the biobank, an essential component of the PMI Cohort Program.
3. 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 blood and urine tests, and grant access to their clinical data from EHRs. Participants' privacy will be ensured with security safeguards, according to the NIH.
4. As partners in the research, participants will have the ongoing chance to provide input into the study design and implementation, as well as access to a wide range of their individual and aggregated study results.
5. Funding for the Data and Research Support Center has been awarded to Nashville, Tenn.-based Vanderbilt University Medical Center, which will work with the Broad Institute in Cambridge, Mass., and Verily, based in Mountain View, Calif. The Data and Research Support Center will collect, organize and provide secure access to what will become one of the world's most expansive and diverse datasets for precision medicine research. The center will also provide research support for the scientific data and analysis tools for the program.
6. Enrollment of PMI Cohort Program participants will occur through two distinct approaches. One approach leverages the strengths of healthcare provider organizations 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 Fairfax, Va.-based Vibrent Health.
7. The NIH will build a network of healthcare provider organizations over time to ensure the participants in the cohort are representative of the geographic, ethnic, racial and socioeconomic diversity of the U.S. The network will include regional and national medical centers, community health centers and medical centers operated by the U.S. Department of Veterans Affairs.