Federal Grant Helps Researchers Evaluate the Process
For many, there's no question U.S. clinical trials are plagued with inefficiencies, and now Vanderbilt University Medical Center is helping to address that problem. Researchers at VUMC and Duke Clinical Research Institute (DCRI) have received a major federal grant to study how multisite clinical trials of new drugs and therapies in children and adults could be conducted more rapidly and efficiently.
The seven-year, $26.5 million grant for a joint Trial Innovation Center (TIC) is supported by the National Institutes of Health's National Center for Advancing Translational Sciences. The new center will be a key component of the Trial Innovation Network, which is the newest part of the Clinical and Translational Science Award (CTSA) Program.
Recruitment, Recruitment, Recruitment
Gordon Bernard, MD
Danny Benjamin, MD, MPH, PhD, faculty associate director of the DCRI, and Gordon Bernard, MD, director of the Vanderbilt Institute for Clinical and Translational Research (VICTR), are the grant's principal investigators. "The first five problems with clinical research is recruitment," said Bernard. "Not because people won't agree to be in studies but because it's challenging to find those who meet the study criteria, who aren't affected by exclusion criteria, and who are in a good location."
Few trials recruit on schedule, which also poses a big problem for researchers. Part of that slowness is related to contracts, ethical reviews and approvals, consents, and recruiting sites, said Bernard. He's been involved in clinical trial trouble shooting since the CTSA's inception 15 years ago. Through ongoing grants, VICTR has pioneered numerous research innovations including REDCap, a web application that helps academic scientists around the globe collect and manage their research data, and the Accelerated Clinical Trial Agreement, which streamlines clinical contracting for multisite studies. Other innovations include a technical system that facilitates and provides infrastructure support for a single Institutional Review Board (IRB) system and ResearchMatch, a nationwide online research volunteer recruitment and engagement service.
Bernard's goal over the next five years is to have trial sites up and running in one month instead of the usual year - a task he hopes to accomplish partially through establishment of a centralized IRB.
"Under the old system, every site has a separate review by IRB, which can take a few weeks to months depending on a whole variety of factors at each institution," he said. "It often takes a year to have approval on all IRB sites."
Bernard also wants to make recruitment more effective through professional recruitment support. "We have to advertise to let doctors and patients know these studies exist," said Bernard, who admits that clinical trial advertising is plagued with shortfalls. "Many who enter trials are actively looking for either the most cutting edge new therapy or as a last resort," he said. "We've discovered in surveys that patients want to go to a place with clinical research because they're guaranteed to get the best current accepted treatment on top of trials."
The Trial Innovation Network will include other TICs, as well as Recruitment Innovation Centers (RICs), which will study ways to engage more volunteers in clinical research. Both programs will leverage the expertise and resources of the national CTSA Program. Vanderbilt is the only designated RIC and one of three trial innovation centers, as well as the coordinating center for the CTSA consortium.