Vanderbilt to lead Direct Volunteers Pilot Studies under Precision Medicine Initiative Cohort Program

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Federal officials with the White House and National Institutes of Health (NIH) announced today that Vanderbilt University Medical Center (VUMC) will lead the Direct Volunteers Pilot Studies under the first grant to be awarded in the federal Precision Medicine Initiative Cohort Program.

The Precision Medicine Initiative Cohort Program's objective is to build a broad and diverse national research cohort of 1 million or more U.S. volunteers whose participation will provide the platform for expanding approaches to precision medicine that will benefit the nation and medical science for decades to come.

The team of researchers involved with the Direct Volunteers Pilot Studies, whose objective is to create a prototype set of technologies and experiments that will inform the successful approach for such a large research cohort, also includes experts from Verily (formerly Google Life Sciences) as well as the University of Michigan, the Broad Institute of the Massachusetts Institute of Technology and Harvard University.

"Volunteers in the pilot will help the research team establish and test innovative methods and technologies for enabling robust participant engagement, as well as user-friendly data collection. This approach will help us learn how to create durable relationships with volunteers, who are partners in the research process, which will be the foundation for a democratized, transformative research environment," said, Francis Collins, M.D., Ph.D., director of the NIH.

"We are excited to play an important role in developing the President's Precision Medicine Initiative, as we work together to advance the understanding of how to enhance health and treat diseases. Our institutional investments in precision medicine, which began more than a decade ago, are bearing fruit, and we have an outstanding group of individuals in place to lead this effort," said Jeff Balser, M.D., Ph.D., vice chancellor for Health Affairs and dean of Vanderbilt University School of Medicine.

A pioneer in Vanderbilt's precision medicine efforts, Josh Denny, M.D., M.S., is principal investigator for the effort, which is supported by a one-year grant from the PMI Cohort Program (NIH Award #1-OT2-OD-023132).

"The Precision Medicine Initiative is a grand experiment on a scale that has never been tested before. We'll pilot how to authentically engage individuals to participate in the program and build the initial informatics and Web infrastructures to support it," said Denny, associate professor of Biomedical Informatics and Medicine who served on the national PMI Working Group of the NIH Advisory Committee to the Director.

Precision medicine uses advanced approaches to data collection and analysis that rapidly assimilate unprecedented amounts of individuals' personal health data, as well as behavioral and environmental data. This information, when combined with genetic and other molecular data, will provide a broad platform that can be used extensively for discoveries that will help advance the science of preventive care, as well as new treatments and potentially cures for diseases. The goal of precision medicine is to match individuals with treatments and preventive strategies that are most likely to work for them.

As part of the Direct Volunteers Pilot Studies, VUMC will create and optimize a prototype informational website that is engaging to a diverse array of potential volunteers, and develop an interface for obtaining consent and basic enrollment and health information that is efficient, effective and secure.

VUMC has emerged as a national leader in precision medicine. Its DNA repository, BioVU, is one of the world's largest, with more than 215,000 genetic samples linked to electronic health records that have been stripped of personal identifiers. This enables researchers to determine how specific genetic variations influence disease risk, treatment outcomes and responses to medications.

"This award speaks to Vanderbilt's investments not only in genomics and pharmacogenomics, but also in community engagement and in the people and informatics tools needed to create, analyze, and make available to the community very large datasets," said Dan Roden, M.D., assistant vice chancellor for Personalized Medicine, and an originator of BioVU.

Vanderbilt researchers involved with the Direct Volunteers Pilot Studies also include Paul Harris, Ph.D., director of the Office of Research Informatics; Consuelo Wilkins, M.D., director of the Meharry-Vanderbilt Alliance; and Sunil Kripalani, M.D., director of Vanderbilt's Effective Health Communication Program.

Bradley Malin, Ph.D., founder and director of Vanderbilt's Health Information Privacy Laboratory, will help construct platforms that protect the privacy of cohort participants. Jill Pulley, MBA, director of Research Support Services in the Office of Research, will oversee program architecture and organization.

This summer, the NIH will award cooperative agreements for the full implementation phase, including establishment of a Coordinating Center to oversee Direct Volunteer recruitment, and Healthcare Provider Organizations to enroll more participants, and a Biobank capable of storing and managing blood, urine and saliva samples for analysis.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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