FYI Research:
New office created to streamline clinical trials

Clinical trials at Carolina are bigger than you might think. With more than 300 industry-sponsored clinical trials bringing in more than $34 million in funding in fiscal year 2001, clinical trials at Carolina are growing rapidly — up from $11 million in fiscal year 1998.

These trials contribute to important discoveries in the safety and efficacy of drug development, treatment and procedures. For example, John Buse, associate professor of medicine and director of the Diabetes Care Center, is involved in a clinical trial called NAVIGATOR, which monitors family members of diabetics to find out whether or not they develop diabetes. “We randomize them to a blood pressure drug or placebo and to a diabetes drug or placebo and follow them for a period of about six years to see first whether we can prevent the development of diabetes, and second, whether we can reduce the risk of dying of a heart attack or stroke,” Buse said.

Since clinical trials are an important and growing part of research at Carolina, a new Office of Clinical Trials (OCT) is being developed to facilitate smoother processing. John Case, associate vice chancellor for research and interim director, describes the new office as a “one-stop shop for PIs and their sponsors.”

In other words, OCT will “perform all administrative, budgetary, legal and regulatory processing functions for all clinical trials,” Case said. A more efficient, centralized office will make it easier to get the growing number of new clinical trials under way. The new office will not only coordinate the processing of clinical trials but also will provide training and standardize policies and procedures for managing the clinical trials process.

OCT was created with the input of two committees, one headed by Eugene Orringer, professor of medicine, who has conducted many clinical trials at the University, and the other headed by Susan Ehringhaus, vice chancellor and general counsel. In addition to using their own experience with clinical trials, they visited similar offices at other universities such as the University of Texas at Galveston and Columbia University to develop a plan for Carolina’s office.

The new office will have two project managers — one for private industry and one for the federal government. These people, when appointed, will serve as the contacts for the principal investigators, their sponsors, the clinical research coordinators and departmental business managers.

In the future the office hopes to expand to meet other needs of investigators and coordinators based on information received from those who use the office in the first year. “We want to be open to ideas about serving our customers, the clinical researchers, and sponsors,” Case said.

OCT currently is located at 440 W. Franklin St. and will move to Chase Hall in the early fall. It will move closer to the health affairs area when renovations there are complete. For more information, visit the Office of Clinical Trials web site at research.unc.edu/oct/ or call 843-2698.

Provided by Research and Economic Development.
Editor: Neil Caudle. Writer: Mary Alice Scott.
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