Clinical trials office to move to College of Medicine this summer

The Office of Clinical Research within UC Health, which coordinates more than 1,000 clinical trials led by College of Medicine faculty each year, will physically and administratively move to the college, tentatively scheduled to occur by July 1.

Everything is being done is to ensure that clinical researchers have enhanced support to conduct their trials, says Brett Kissela, MD, senior associate dean for clinical research. The change also will eliminate the need for researchers to go to different places for assistance. Kissela explains that research funded by pharma has gone through UC Health while studies funded by the National Institutes of Health (NIH) have gone through the college. But some studies, such as those funded by both pharma and the NIH fell “into a gray zone.” Studies supported by community businesses also did not fit neatly.

Kissela also noted that there have been difficulties utilizing two different accounting systems between UC Health and the university. He says that one of the things that started him thinking about this issue was his inability to understand whether the clinical research enterprise was making or losing money. “I couldn’t answer that because of the various accounting systems and that’s what set the whole thing into motion.”

“After a long decision process involving stakeholders, we started  the moving process in late 2019, but it got stalled because of a variety of things including the pandemic, says Kissela, who will retain his title of chief of research services at UC Health with the move. Maria Stivers, will continue to lead the office as senior director.

The office, which has been known as the Office of Clinical Research while at UC Health, will also get a new name, and Kissela would like it to be suggested by the College of Medicine community. He is seeking suggestions, which could be straightforward, creative or catchy, but decorum should be exercised. Suggestions should be emailed by May 12 to researchstudies@uchealth.com. The winning name will be selected by Kissela and the research office staff, and the person offering the suggestion will receive a prize.

Shifting a 14-person office that coordinates more than $15 million in clinical research annually is not a simple matter, he says. After college and UC Health leadership extensively reviewed the idea and agreed to the move, dozens of people have been involved in planning the transfer, working on legal, administrative and financial issues. Additionally, plans are being developed to ensure seamless support for researchers, their staff and participants enrolled in trials during the shift.

“It was very clear to everyone that this made sense. It’s taken time to align everyone in the right way and make the process smooth. We can’t stop the research while we’re rearranging everything,” Kissela says.

Ease for researchers is the bottom line, he stresses.

“We want to make it easy for researchers. It’s going to be one-stop shopping. if you want assistance with research, you will either email us or stop down to our physical location and we'll help you take care of it. It doesn't matter what kind of research work you’re doing, we want to make it easy for the researchers and build an infrastructure in the background that’s less complicated and eliminates inefficiencies,” Kissela says. “If we accomplish this, our talented researchers will be able to invest more time and energy into getting trials and enrolling subjects, writing grants and improving the whole research enterprise.”

The clinical research office will be located in new offices on the G-Level of the Medical Sciences Building. Kissela, who also serves as the chair and Albert Barnes Voorheis Professor in the Department of Neurology and Rehabilitation Medicine, expects the new offices to be open and staff transferred within the next several months.

Another benefit Kissela sees with the office transfer is providing researchers with more access to support from the Center for Clinical and Translational Science and Training (CCTST).

“Our vision is that we’re going to be re-emphasizing the CCTST, which is meant to support all forms of clinical and translational research. I want our faculty to get more engaged with the CCTST and utilize services and help we can offer,” says Kissela, who is a co-principal investigator on the CCTST grant. “I think we’ll be able to blend together the CCTST and the clinical research office and get much greater participation in the CCTST. There’s a lot of help this infrastructure grant can offer to assist clinical and translational researchers.”

The CCTST offers many services for researchers including pilot grants, grant writing, regulatory and ethics guidance, biostatistics methodology, trial design, bioinformatics and assistance with community engagement. It also offers a variety of training opportunities for all research professionals.

Another important change is that the clinical research office will be offering researchers access to Signal Path a clinical trial management software system. Implementation is starting in a limited fashion, and all college researchers are expected to have access by the end of 2021.

“What we hope to do is to continue to add services and benefits that make it easier for our researchers to succeed. For example, we’re one of the first large academic centers to buy Signal Path. We think it’s going to be the best-in-class for a long time and will become a day-to-day resource that researchers are going to use continuously. It will allow us to have much better enterprise-wide reporting so we can be more efficient and effective,” Kissela says.

“Our hope is that we’ll build up our research portfolio,” he added. “Our ideal world is that we can offer every clinical patient at UC Health a trial for whatever they come in for. They don’t have to participate, but at least we can offer it to them. For diseases where we currently don’t have a cure, we want to make sure that we are offering each patient a chance to help discover a new treatment.”

Featured image at top of Brett Kissela, MD/Colleen Kelley/UC Creative + Brand.