Whether it’s new medicines, new treatments or new devices, many advances in the world of surgery happen through clinical trials — rigorously monitored and studied trials in a small group of people before the drug, treatment, or device is submitted for wider approval.
“We can conceptualize improvements in patient care, and we can test them in the lab, but by translating that into actual patient care delivery that we can study, we can determine how efficacious these interventions are,” says Robert Meguid, MD, associate vice chair of clinical research for the University of Colorado Department of Surgery. “Then we can determine if it’s something we can scale up to use more broadly for different patient populations.”
A resource for investigators
The CU Department of Surgery’s Clinical Research Office, overseen by Tracey MacDermott, is the centralized hub for all surgery-related clinical trials. MacDermott and her staff coordinate trials, help investigators write grants, secure funding, and enroll participants, and they provide regulatory support throughout the clinical trial process.
“We want investigators who are coming through the door to know they have a resource available,” MacDermott says. “We ask them, ‘Are you looking to write your own protocol? Has a sponsor reached out to you?’ We let them know that we're here to get their project going, and we can see it through from beginning to end.”
Homegrown and national trials
The CU surgery department has approximately 200 clinical trials in process at any given time, Meguid says, funded by a mix of national grants, internal grants, and funds from private companies who support the department’s work testing surgical innovations. Some trials are designed and run by CU surgery faculty members; others are national trials overseen by other institutions.
“National clinical trials are where the principal investigator wants additional sites to implement,” he says. “We want to make sure we're visible as a site that can offer opportunities for patient improvement.”
Benefit for patients
Whether they are homegrown trials or trials that originated at other institutions, clinical trials at the CU Department of Surgery not only provide faculty members, residents, and others with valuable research experience; they also benefit patients, who are often able to receive new treatments years before they are available to the general public.
“It gives them the opportunity to come to a place that does this and does it well,” MacDermott says. “We have a wide scope of potential trials that might be available to a patient, and we have a team of people who want to improve human health. It’s also great to see the patients who want to be part of making that next advancement happen. When they think that, ‘This may not help me, but it could help somebody else,’ that alone is a motivator for patients. It's their intrinsic, outward desire to give something back to the future.”
Wide-ranging research
Among the research projects underway at the CU Department of Surgery are ones to cure blindness; improve recovery for patients who undergo breast reconstruction surgery and surgery for esophageal cancer; use breath samples to diagnose lung cancer; and increase survival for patients with traumatic injury that involves major bleeding. With the help of the Clinical Research Office, investigators are looking to add many more projects to that list.
“We need to think about what we can do to advance patient care, then we need to safely and carefully study those implementations to see if they're effective,” Meguid says. “That’s what the Clinical Research Office supports.”
