In a $26.5 million, seven-year grant funded by the National Institutes of Health (NIH), researchers from the Duke Clinical Research Institute (DCRI) and Vanderbilt University Medical Center (VUMC) will determine how multisite clinical trials for new drugs and therapies could be conducted in a more efficient manner.

The Duke-Vanderbilt Trial Innovation Center (TIC) will consist of three components: a Study Design Core where the investigators will develop protocols and reasonable study budgets, a Study Start-up Core that will create Master Clinical Trial Agreements and also ensure that trials are underway as quickly as possible, and a Study Conduct Core that will help investigators from the start of a trial to the broadcasting of results.

Dr. Danny Benjamin, MPH, Ph.D., faculty associate director of DCRI, and Dr. Gordon Bernard, director of the Vanderbilt Institute for Clinical and Translational Research (VICTR), are the grant’s principal investigators.
“This is an exciting and unprecedented opportunity to greatly improve the conduct of clinical research in this country,” Bernard told HCB News, and also said that the researchers expect to begin creating the infrastructure immediately.

“The DCRI and Vanderbilt partnership is a perfect fit for the TIC,” said Benjamin 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.”

According to the announcement, the Duke-Vanderbilt TIC is supported by the National Center for Advancing Translational Sciences (NCATS) and will be a key component of the Trial Innovation Network, which is part of the Clinical and Translational Science Award (CTSA) program.

An innovation team that consists of Paul Harris, Ph.D., and Brian McCourt will produce software to support the three components of the TIC, said Bernard.

In February, NIH awarded Cincinnati Children’s Hospital Medical Center with a $32.5 million, five year grant for researchers to study why some pediatric patients are born with heart problems, and also to develop treatments.

At that time, the team had gathered clinical, environmental and genomic data from over 10,000 children with heart defects, with Cincinnati Children’s serving as the research program’s “genomic data hub”, where it will collect, integrate and provide more than 150 terabytes of molecular data.

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