The Duke Clinical Research Institute (DCRI) and Vanderbilt University Medical Center (VUMC) have received a major federal grant to study how to improve the sped and efficiency of multisite clinical trials of new therapies.
The seven-year, $26.5 million grant for a joint Trial Innovation Center (TIC) is supported by the NIH’s National Center for Advancing Translational Sciences (NCATS). The center will be a key component of the Trial Innovation Network, the newest piece of the Clinical and Translational Science Award (CTSA) Program.
Principal investigators for the grant are Danny Benjamin M.D., M.P.H., Ph.D., the DCRI’s faculty associate director; and Gordon Bernard, M.D., director of the Vanderbilt Institute for Clinical and Translational Research (VICTR).
“The DCRI and Vanderbilt partnership is a perfect fit for the TIC,” Dr. Benjamin said in a statement. “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.”
The Duke-Vanderbilt TIC will consist of:
- A Study Design Core to be led by the DCRI’s Kevin Anstrom, Ph.D., and Frank Harrell, Ph.D., of the Vanderbilt Institute for Clinical and Translational Research (VICTR), with operational leadership from the DCRI’s Lori Poole. The study design core will work with investigators to develop protocols and study budgets.
- A Study Start-up Core, to be led by VICTR Director Gordon Bernard, M.D., with operational leadership from the DCRI’s Marc Ingham. The study start-up core will establish Master Clinical Trial Agreements and oversee a central Institutional Review Board, with the goal of getting trials underway as quickly as possible.
- A Study Conduct Core, led by the DCRI’s P. Brian Smith, M.D., M.H.S., M.P.H., with operational leadership from the DCRI’s Theresa Jasion, will provide support to investigators from initial trial design to dissemination of results.
All stages of the TIC will be assisted by an Innovations Core to be led by VICTR’s Paul Harris, Ph.D., and the DCRI’s Brian McCourt. The innovations core will seek to streamline and expedite interactions with the clinical trial sites.
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 are expected to apply expertise and resources of the NCATS CTSA program.