Vanderbilt University Medical Center has been selected to lead the first-of-its-kind study, expected to change the future of precision medicine.
In February, officials with the White House and National Institutes of Health (NIH) announced VUMC would lead the Direct Volunteers Pilot Studies under the first grant to be awarded in the federal Precision Medicine Initiative Cohort Program. The 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 to benefit medical science for decades to come.
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. The initiative is supported by a one-year grant from the PMI Cohort Program.
A National Effort with a Familiar Face
Joshua Denny, MD, MS, was named principal investigator for the unprecedented study. An associate professor of Biomedical Informatics and Medicine, he served on the national PMI Working Group of the NIH Advisory Committee to the Director. Denny, who has been a fixture at Vanderbilt since his undergrad years, began his work in genomics in 2007 when the NIH kicked off a program that would become the Electronic Medical Records and Genomics Network (eMERGE).
“I had also been working on Vanderbilt’s biobank to help launch that,” Denny said. “I became very deeply involved in the genetics aspect of medicine – how they alter metabolism and response.”
He went on to lead the research warehouse side of BioVU, now the largest single site biobank in the world. Denny then joined an elite group of researchers partnering with the NIH and wrote a series of papers for internal consumption outlining key aspects of the precision medicine initiative. The group convened April 2015 and their report was released in September.
In February 2016, the first of many anticipated grants was awarded to Vanderbilt. While VUMC will partner with other sites to collaborate on data collection and promotion, VUMC is the only clinical site for the study and received the single scientific award. Denny hopes the program will become a decades long study, comparing it the famed Framingham Heart Study, which began in 1948 with 5,209 adult subjects and is now on its third generation of participants. That ongoing study is widely credited for revealing now common understandings about heart disease and heart health.
It Takes a Village … or Two
The greatest initial challenge will be enrolling those 1 million volunteers: a feat Denny hopes to achieve in four to five years. “The biggest benefit of participating is contributing to science and being able to shape it,” Denny said. “Participants also win from the standpoint of being able to get some of their data back and be a part of communities where you can provide a voice.”
While the program is still in its infancy, Denny hopes to soon learn how to research and engage that volume of participants so they want to stay involved. The next few months will be spent figuring out mechanics and building the initial infrastructure. Denny said local providers will play a key role in helping to recruit participants, as well.
“There will come a time when providers will be more engaged, once we’re really ready to start recruiting,” Denny said. “Anyone in the country can volunteer, which means providers can share information with their patients. A lot of things come into play.”
Vanderbilt researchers involved with the Direct Volunteers Pilot Studies also include Paul Harris, PhD, director of the Office of Research Informatics; Consuelo Wilkins, MD, director of the Meharry-Vanderbilt Alliance; and Sunil Kripalani, MD, director of Vanderbilt’s Effective Health Communication Program.
Bradley Malin, PhD, 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, Healthcare Provider Organizations to enroll more participants, and a Biobank capable of storing and managing blood, urine and saliva samples for analysis.
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