Researchers in the Vanderbilt Institute for Clinical and Translational Research (VICTR) have been awarded two five-year federal grants totaling $51 million to harness new and existing approaches for boosting recruitment and removing roadblocks to the efficiency of conducting clinical trials throughout the country.
The grants, from the National Center for Advancing Translational Sciences, part of the National Institutes of Health (NIH), recognize the expertise, leadership and plethora of clinical research tools developed over the past several years at VICTR, home of Vanderbilt University Medical Center’s NIH-funded Clinical and Translational Science Award (CTSA).
“VICTR is uniquely poised to carry out the work of these two programs given experience gained over the past seven years of the previous funding cycle and the ongoing work coordinating a number of other major NIH programs,” said VICTR’s founding director, Gordon Bernard, MD.
“I am confident that there are few if any other organizations like VICTR on academic campuses,” said Bernard, the Melinda Owen Bass Professor of Medicine, who is nationally recognized for his leadership in clinical research.
“These awards are significant and will allow our teams to play a major role in driving the next wave of innovation in clinical trials,” added Paul Harris, PhD, Vice President for Research Informatics at VUMC, who also has played a leading role in VICTR.
“Our end goal is to improve the speed, quality and efficiency of clinical and translational research, ultimately advancing the field of medicine for the betterment of society,” Harris said.
The first grant funds a program called CHOIR, for Catalyzing and Harmonizing Operational Innovation for Recruitment, which will apply a broad range of tools developed at VICTR’s Recruitment Innovation Center (RIC) for improving the recruitment of participants into clinical trials.
Established in 2016, the RIC — the only one in the country — develops and tests innovative approaches to recruiting clinical trial participants, with an emphasis on engaging marginalized populations, women and older adults.
CHOIR will be led by multiple investigators including Harris, who will be responsible for bioinformatics development, and Consuelo Wilkins, MD, MSCI, Senior Vice President for Health Equity and Inclusive Excellence at VUMC, who will oversee community engagement and recruitment of marginalized populations.
Since it was founded in 2007, VICTR has fostered the development of several clinical research innovations, including ResearchMatch, an online national volunteer recruitment registry, and REDCap, a web-based research management application used worldwide.
CHOIR will build upon these and other recruitment-related assets and will provide a national “home” for sharing recruitment tools, training, materials and best practices for engaging diverse populations.
“These innovations acknowledge that recruitment is not a one-time activity but is a continuum, and requires skilled, trustworthy clinical trial teams,” Wilkins said.
The other grant supports ECSTATIC, Engaging Cooperative Sites for Trial Acceleration, Trust, Innovation and Capability, which will expand the capability of VICTR’s Trial Innovation Center (TIC). Since 2016, the TIC has investigated how multisite clinical trials of new drugs and therapies can be conducted more rapidly, efficiently, and with higher quality.
Among the investigators of the ECSTATIC grant are Bernard, Wesley Self, MD, MPH, Senior Vice President for Clinical Research, who succeeded Bernard as VICTR director in July, and former Vanderbilt biostatistics professor Christopher Lindsell, PhD, now at the Duke Clinical Research Institute.
The program will utilize mobile data collection, electronic consent, virtual and remote study participation, electronic health record research, institutional review board coordination, pragmatic clinical trials, learning health care systems research and community engagement.
It will draw on diverse expertise, including CTSA-aligned coordinating centers around the country, the national Biostatistics, Epidemiology and Research Design group, and historically Black colleges and universities.
A key partner is Meharry Medical College, the nation’s largest private, historically Black academic health care center dedicated to educating health care professionals and biomedical scientists.
“The goal of our TIC,” Self said, “is to build, test and share new resources that will enhance and accelerate rigorous, reproducible research and improve human health.”
Research reported here is supported by grants TR004432 and TR004437.