Researchers at the Duke Clinical Research Institute (DCRI) and Vanderbilt University Medical Center (VUMC) have received a major federal grant to study how multisite clinical trials of new drugs and therapies in children and adults can 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 Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). The 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.

Danny Benjamin, M.D., MPH, Ph.D., faculty associate director of the DCRI, and Gordon Bernard, M.D., director of the Vanderbilt Institute for Clinical and Translational Research (VICTR), are the grant’s principal investigators.

“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.”

“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 Bernard, executive vice president for research at VUMC.

The Duke-Vanderbilt TIC will have three components:

• A Study Design Core, led by the DCRI’s Kevin Anstrom, Ph.D., and VICTR’s Frank Harrell, Ph.D., with operational leadership from the DCRI’s Lori Poole, will work with investigators to develop robust protocols and feasible study budgets.
• A Study Start-up Core, led by Bernard with operational leadership from the DCRI’s Marc Ingham, will establish Master Clinical Trial Agreements and oversee a central Institutional Review Board to get the trials underway as quickly as possible.
• A Study Conduct Core, led by the DCRI’s P. Brian Smith, M.D., MHS, MPH, with operational leadership from the DCRI’s Theresa Jasion, will provide support to investigators from initial trial design to dissemination of results.

All stages will be assisted by an Innovations Core, led by VICTR’s Paul Harris, Ph.D., and the DCRI’s Brian McCourt, which will create innovative solutions to streamline and expedite interactions with the clinical trial sites.

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 NCATS CTSA Program.