Revamping the Clinical Trials Infrastructure

UNC-Chapel Hill is a well-established site of clinical research, with a large number of trials across many disciplines. Yet the process by which these clinical trials are conducted is inefficient and costly.

In February of last year, Vice Chancellor for Research Barbara Entwisle, Ph.D., chartered a Clinical Trials Task Force to take a hard look at the infrastructure supporting these crucial studies at UNC. Co-chaired by Marschall Runge, M.D., Ph.D., director of the NC TraCS Institute, the task force met biweekly and sought advice from industry experts within clinical research organizations and consulting firms.

In September the members issued 34 recommendations they feel are needed to position the University for growth and success in clinical trials. They recommended changes that would enable clinical trial investigators to do 4 key things: execute contracts quickly; get IRB approval quickly; recruit subjects effectively, efficiently, and in a timely manner; conduct protocols as specified and provide sponsors with quality data that is error free. Today, many of those changes are underway.

“We are eager to implement the task force’s recommendations and changes are already underway,” said Entwisle. “We are taking steps to ensure the Office facilitates quality clinical trial research, with an emphasis on providing more comprehensive administrative services to our investigators.”

The expanded OCT will soon encompass a number of services such as financial responsibility, regulatory submissions, training and quality assurance. The Budget Committee has appropriated new dollars for OCT to accommodate the change, as the office has been operating with a budget appropriated over 11 years ago. NC TraCS, home of UNC’s NIH Clinical and Translational Awards (CTSAs), has also devoted resources to increasing industry funded clinical trials and improving recruitment and trials management.

Other recommendations of the task force include moving OCT to more functional office space, adding critical contract management positions, expanding the use of biomedical informatics tools like the Clinical Research Management System and Carolina Data Warehouse for Health, and improving financial and regulatory oversight.

Members of the task force include Andy Johns (co‐chair); Marschall Runge, M.D., Ph.D. (co‐chair); John Buse, M.D., Ph.D.; Ed Finerty; Brent Lamm; Carol Lorenz, P.T., Ph.D.; Dan Nelson; Steven Offenbacher, D.D.S.; David Parker, J.D.; Herb Patterson, Pharm.D.; Norman Sharpless, M.D.; Rosemary Simpson; and Bruce Wicks, M.H.A., F.A.C.H.E.