The creation and implementation of ONE UNC Clinical Research will enhance the efficiency of Carolina’s clinical trial process, resulting in more research, increased patient engagement, and greater strategic partnerships.
The clinical trial startup procedure for UNC Health and UNC-Chapel Hill is getting a thorough evaluation from leaders across campus. The goals of the new effort are to synergize resources across both units, cut bureaucratic red tape, and clarify the sometimes prohibitive set of requirements to start a clinical trial in a UNC Health hospital or for a University research project.
The initiative — half process review and half creation of a new office — started in September 2022. ONE UNC Clinical Research, an offshoot program of ONE UNC Health, is spearheaded by Andy Johns, senior associate vice chancellor for research, and Shakira Henderson, who has appointments in the School of Medicine and UNC Health and serves as assistant vice chancellor for clinical research in OVCR.
“We kicked things off by looking at the trial startup process, and we quickly learned it’s not easy to do here,” Henderson says. “There are possibly over 50 touchpoints that researchers must navigate to bring their research from the university to the clinic. Our goal is to decrease study startup time by at least 50%.”
Decreasing startup time for clinical trials could be transformative for Carolina research. It will make clinical trials more accessible across UNC Health System hospitals and clinical sites in the state, expanding a reach that is now mostly limited to the UNC Medical Center in Chapel Hill. Having clearer parameters on what it takes to start a clinical trial will also attract more external partners, expanding the research enterprise even further.
To reach this goal, three offices are working together: the Office of Research Support and Compliance, the Office of Clinical Trials, and the Clinical Research Support Office. In December, initiative members finished developing recommendations to streamline the clinical research administrative processes between the University and health care system. Now, a committee is using those recommendations to design protocols for each aspect of the startup process. With collaboration from more than 200 people at Carolina, this initiative will carry out over the next two years, culminating in an easier and faster startup procedure.
“We are rich in research expertise at UNC-Chapel Hill and UNC Health,” Henderson says. “The work we are doing will make research an integral part of UNC Health clinical care. It will also help us retain more of the incredible research staff we train and attract new physician scientists, all while fulfilling our number-one goal of helping more patients.”