As part of the study, PMI volunteers will contribute a range of health, environment, and lifestyle information through blood and urine tests as well as electronic health records.
While the study won’t focus on a specific disease, researchers hope to gain a better understanding of several important health questions. The breadth of the study will allow researchers to create a platform to enable trials of targeted therapies, gain a better understanding of pharmacogenomics and the use of mobile health, among others.
“There are many aspects of the program that will require thoughtful planning and implementation—from participant engagement to data security and plenty of other things in between,” Joni Rutter, Ph.D., Director of the Division of Programs and Strategic Implementation, with the PMI Cohort Program, NIH, told us.
With its unprecedented study size, Rutter explained that the NIH plans “to approach this as a constant learning process, refining our approaches and iterating as we go.”
One already defined approach will be to use mobile health devices and applications to allow participants to provide data in real time – a ubiquitous trend in clinical studies as of late.
Volunteers will be able to enroll directly through Participant Technologies Centers – who will develop, test, and maintain the program’s mobile applications – or through one of many health care provider organizations (HPO).
“Guiding all of our efforts are a set of core values, including the commitments to involve our participants as partners and to make data broadly accessible for research purposes,” said Rutter.
Rutter added that the NIH is planning a national campaign to raise awareness about the PMI Cohort Program and the opportunity for participants to join the research effort.
“The campaign will include media outreach and collaborations with local and national organizations, among other strategies to ensure that our participants reflect America’s rich diversity,” said Rutter.
Additionally, the program’s HPO partners will promote enrollment opportunities to their patients in the health care setting. The immediate next step is to establish governance for the program.
“We’ll be setting up an executive committee, steering committee, and working groups to develop more detailed plans for the program in anticipation of the national launch later this year,” explained Rutter.
“Then we’ll work to stand up the biobank and Participant Technologies Center (PTC); have our health care provider organizations work together with the PTC to finalize the protocol; conduct data transfer tests with the Data and Research Support Center; and begin initial outreach activities to raise awareness of the program, among other activities,” she said.
The Data and Research Support Center has been awarded to Vanderbilt University Medical Center, working with the Broad Institute, and Verily Life Sciences. The center will acquire, organize, and provide secure access to the dataset, which, according to NIH, “will be one of the world’s largest and most diverse datasets for precision medicine research.”
The center will also provide research support and analysis tools to a range of researchers from across the industry who will be able to propose further studies using the information gathered during the PMI Cohort Program.
For more information, visit www.nih.gov/precision-medicine-initiative-cohort-program.