The NIH has awarded a seven-year, $26.5 million federal grant to researchers at Vanderbilt University Medical Center (VUMC) and Duke Clinical Research Institute (DCRI) to study ways in which multisite clinical trials can be conducted more rapidly and efficiently.
The grant to establish a joint Trial Innovation Center (TIC) is supported by NIH’s National Center for Advancing Translational Sciences (NCATS). The TIC will be a key component of the Trial Innovation Network, which is the newest part of the NIH’s Clinical and Translational Science Award (CTSA) Program.
Danny Benjamin, M.D., MPH, Ph.D., faculty associate director of the DCRI and one of the TIC’s principal investigators, said one goal is to pool talent, expertise and ideas from researchers to improve the clinical trial process. In addition to Duke and Vanderbilt, Johns Hopkins and the University of Utah will also have representatives at the new TIC.
“The DCRI and Vanderbilt partnership is a perfect fit for the TIC,” said Benjamin. “The academic research organization model at the DCRI and Vanderbilt’s informatics and central institutional review board model are poised to immediately contribute to the NIH’s vision of high-functioning networks for clinical research.”
Benjamin continued, “One of the mandates is to study innovations around trials that have already been conducted. Rather than adding another layer of regulatory burden and hoping for the best, the idea is to make sure what we’re doing is improving the conduct.”
The Trial Innovation Network will include other TICs as well as Recruitment Innovation Centers, which will study ways to engage more volunteers in clinical research. Both programs will leverage the expertise and resources of the CTSA Program.
In the last few years, there has been growing emphasis on finding ways to improve trial speed and efficiency. Nearly every major pharma company has assigned resources to this area, and organizations such as the Society for Clinical Research Sites (SCRS) and TransCelerate BioPharma have been born as a result.
Improving the clinical research process “is a major concern to the industry,” said Diana Foster, Ph.D., vice president of Strategy and Development for SCRS. “Having the NIH come in at such a significant level and support a grant such as this is very exciting. It’s absolutely the right timing for collaboration among many individuals who have been focused on this in detail over the last few years.”
Market forces continue to compel efficiency in the clinical trial process, said Scott Ballenger, founder of the Trial Acceleration Institute, which collaborates with clinical trial stakeholders to improve study cycle times.
“Today, joining those market pressures are infrastructure, time, volume and practical constraints, such as limited investigator bandwidth and more complex protocols,” Ballenger explained. “We have to look to new paradigms and technology to shoulder the breadth of today’s clinical trial demand with our limited physical and time-bound resources.”
The Duke-Vanderbilt TIC will have three components. A Study Design Core will work with investigators to develop robust protocols and feasible study budgets; a Study Start-up Core will establish Master Clinical Trial Agreements and oversee a central Institutional Review Board to get the trials underway as quickly as possible; and a Study Conduct Core will provide support to investigators from initial trial design to dissemination of results.
All of these stages will be assisted by an Innovations Core, tasked with creating innovative solutions to streamline and expedite interactions with the clinical trial sites.
“We’ve had success at the DCRI with [creating] master contracts as far as the proof of concept is concerned,” Benjamin said. “There are places where proof of concept has been done for a lot of helpful incremental innovation. One of the things that makes this [grant-funded initiative] different is that we will take those proof of concepts and house them under one roof for study.”
“We are excited about the opportunity to be on the ground floor of building a new infrastructure for the efficient conduct of high-quality clinical research that has a major impact on human health,” said Gordon Bernard, executive vice president for research at VUMC and the second principal investigator for the grant.
The end result of the TIC’s study has wide-ranging potential, Benjamin noted. “Because it is NIH-sponsored, populations that really are desperate for better trials and better interventions, such as children’s health and geriatrics, should especially benefit.”
This article was reprinted from Volume 20, Issue 28, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »