Clinical trials are essential for scientific discovery and for improving human health. Yet many studies are stopped prematurely because they fail to recruit enough study participants.
To address this problem, Vanderbilt University Medical Center (VUMC) has received a five-year, $14 million grant (TR001579) from the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health to establish a Recruitment Innovation Center (RIC).
The Vanderbilt RIC “will develop and test innovative approaches to engaging minorities, women and older adults in clinical trials including studying interventions to improve trust, one of the most commonly-cited barriers to research participation,” said Consuelo Wilkins, M.D., MSCI, co-principal investigator of the grant.
The Vanderbilt RIC will be a key component of NCATS’ Trial Innovation Network, a new Clinical and Translational Science Awards (CTSA) Program initiative. The Trial Innovation Network will also feature Trial Innovation Centers and will leverage the expertise and resources of the CTSA Program.
Paul Harris, Ph.D., M.S., professor of Biomedical Informatics and Biomedical Engineering and director of Research Informatics in the Vanderbilt Institute for Clinical and Translational Research (VICTR), will direct the new Vanderbilt center and will serve as principal investigator for informatics development.
Wilkins, who is executive director of the Meharry-Vanderbilt Alliance and associate professor of Medicine at Vanderbilt and Meharry, will serve as principal investigator for community and stakeholder engagement.
“We are really excited to support the new NCATS Trial Innovation Network as a Recruitment Innovation Center and have assembled a unique team of informatics, community engagement and implementation science experts from around the country to lead innovation in participant recruitment and retention,” Harris said.
“This is a unique opportunity to be part of a paradigm shift in how multi-site studies are organized, launched and supported across the United States,” he said.
Columbia University, the Ohio State University, Rockefeller University and the University of Utah, which — like VICTR — have centers supported by NCATS’ Clinical and Translational Science Awards Program, will partner with VUMC to provide expertise in recruitment, informatics and other areas to aid the effort.
Vanderbilt faculty members with expertise in recruiting special populations into clinical trials, including Shari Barkin, M.D., MSHS, Michael DeBaun, M.D., MPH, and Katherine Hartmann, M.D., Ph.D., also will participate in the new center.
Scientists are just beginning to understand how genetic variations in different racial groups can affect response to drugs used to treat heart disease and cancer. Yet recruitment of underrepresented minorities has been especially difficult.
Approaches that already are being used at VUMC and elsewhere to engage more people in research include:
- ResearchMatch (http://www.researchmatch.org), a nationwide online research volunteer recruitment and engagement service developed by Harris and his colleagues, which will be adapted and expanded;
- Community Research Partners (http://communityresearchpartners.net), a pilot website developed through VICTR that helps match researchers with community members and organizations; and
- Trial Finder (www.researchmatch.org/trials/), located within the ResearchMatch portal, which helps highly motivated patients and family members to quickly find the right clinical trials for them.
These methods of engagement work. Last year, Wilkins and colleagues reported that implementing these methods in a clinical trial recruiting African-American women increased enrollment by 78 percent and met recruitment goals 16 months ahead of schedule.
Wilkins is co-principal investigator of another recently awarded NIH grant to establish a Center of Excellence in Precision Medicine and Population Health jointly run by Vanderbilt, Meharry and the University of Miami.
