Department of Surgery Spotlight
Surgery Clinical Trials Office (SurgCTO)
The Department of Surgery, one of the largest in the University of Minnesota Medical School, has 11 divisions as well as a number of research programs, centers, and institutes. Each month, we will focus on the history, achievements, and role of one of those subunits of our department.
This month, the spotlight is on the Surgery Clinical Trials Office (SurgCTO), whose team approach to the management side of clinical research ensures that researchers themselves do not have to handle administrative, compliance and financial tasks but can instead concentrate on research. We spoke with administrative director Bob Bailey, who has been with SurgCTO from its start in 2012 and has guided it through significant growth under the overall leadership of medical director Arthur Matas, MD.
Previous Spotlight: Experimental Surgical Services
Supporting All Phases of Clinical Research
“If we can’t do it, we will find someone who can,” says Bailey. SurgCTO is set up to provide one-stop shopping for principal investigators (PIs) to have their clinical research managed throughout their study’s life cycle, including startup, coordination, financial management, and closeout.
Currently, SurgCTO manages 47 clinical research trials in various phases of enrollment and follow-up, with a mix of investigator-initiated, industry-sponsored and government-funded projects. Active clinical research trials are managed by SurgCTO for the following Department of Surgery divisions – bariatric, vascular, cardiothoracic and solid-organ transplant surgery.
Interim department chair Sayeed Ikramuddin, MD, MHA, emphasizes the importance of having SurgCTO as a research resource for the Department of Surgery. “Executing a clinical trial is a complex and underappreciated process,” says Ikramuddin. “When done poorly, it leads to poor enrollment and significant encumbrances; however, when done well, it engages the sponsor, investigator, and participants.” He sees clinical trials as the backbone of and differentiator between academic practices.
What is the Surgery Clinical Trials Office?
The Surgery Clinical Trials Office (SurgCTO) supports the research activities for the Department of Surgery clinical faculty at the University of Minnesota. SurgCTO is currently conducting approximately 47 clinical trials in various phases of enrollment, follow-up with a mix of investigator-initiated, industry-sponsored and government-sponsored trails. SurgCTO is available to collaborate with and provide support for investigators and their research teams in all phases of clinical research, including the organization, implementation and completion of clinical research studies.
What is its primary role?
- To provide quality staff and services for research that is responsive and appropriate to both the investigator and the needs of the community;
- To promote public and professional education and awareness regarding clinical research;
- To contribute to medical and intellectual advancements;
- To contribute and uphold the missions of the University of Minnesota and the Department of Surgery.
What services are available to researchers?
Services available include, but are not limited to:
- Financial Management
- Project Management
- Study Start Up
- Study Coordination
- Study Closeout
Creating a Team Approach
Bailey explains, “Historically, divisions would each hire full-time research coordinators to manage all clinical trials, but with the exhaustive list of tasks requiring meticulous attention to detail, they would become overwhelmed with trying to do everything.” Inevitably, coordinators would prioritize some tasks (usually those involving study participants’ visits and safety) and put others (such as regulatory and financial tasks) on the back burner, leading to issues with compliance and budgeting. The ultimate result was discontentment and high turnover among research coordinators, because they felt they were not able to do their jobs effectively.
In the past, “when a research coordinator would leave, there would be disruption until a new coordinator was hired,” says Bailey. “But now, we have built-in backups within our organizational structure, so there is minimal disruption.”
The SurgCTO team is comprised of three project managers, Sara Eischen, Mary Farnsworth and Kathleen Kane, who collectively have over 35 years of experience in clinical trials research at the University. In addition to the team of project managers, are six clinical research coordinators, three data coordinators, five student research assistants and one administrative assistant.
Steve Huddleston, MD, PhD, a cardiothoracic surgeon, relies on SurgCTO expertise to manage his clinical trials. “The SurgCTO group has advanced the mission of the Division of Cardiothoracic Surgery and my research interests exponentially, through their expertise about the IRB process, research compliance and organization and implementation of protocols.” In particular, he says, “Kathleen Kane has been a tremendous addition to our research efforts and will benefit the care of our patients through her efforts to complete our clinical and translational research projects.”
SurgCTO’s structure meets the needs of divisions with very robust clinical trials as well as those that may need only part-time assistance. Divisions can customize their service requests based on their needs, whether that means utilizing SurgCTO for only data coordination or study closeout, or SurgCTO can manage an entire research project from start to finish. SurgCTO’s approach focuses on specialization – tasks common to various trials are shared according to the expertise of individual SurgCTO staff members.
This team approach replaced the old model, in which each division’s independent research coordinator had to take on all of the different roles and try to do it all. “The SurgCTO group has advanced the mission of the Division of Cardiothoracic Surgery and my research interests exponentially, through their expertise about the IRB process, research compliance and organization and implementation of protocols," says Huddleston.Efficiency has increased and staff satisfaction has improved, with clear pathways for advancement and with far less burnout.
And the cost savings are clear. In the past, each division’s research coordinator represented a fixed ongoing expense, regardless of how many hours worked on a project; in contrast, SurgCTO charges the division an hourly rate, and only when it has a project in the pipeline.
Years in the Department of Surgery
Bob Bailey – 18 years
Becky Johnson – 11 years
Monica Myers – 9 years
Mary Farnsworth – 8 years
Kathleen Kane – 5 years
Adam Greer – 2 years
Marcia Brott – 1 year
Ashley Roman – 1 year
Michelle Landeweer – <1 year
Lauren Huffman – <1 year
Kyla Roman – <1 year
Alison Oase – <1 year
Sara Eischen – <1 year
Risi Eddy – <1 year
Minwoo Kim – <1 year
Sierra Fandrick – <1 year
Danielle Tran – <2 years
Payton Kaiser – <2 years
Growing to meet researchers’ needs
SurgCTO has evolved since its founding in 1987, by Matas, as the Kidney Transplant Research Office (considered the nation’s largest long-term database of information on kidney donors and recipients). In 2002, that office merged with other transplant groups on campus to form Transplant Information Services; in 2012, Fairview acquired the database. The research group remained with UMN and became an Internal Sales Organization (ISO), named the Transplant Research Organization (TRO). Finally, in June 2017, TRO became a department-wide resource and was renamed the Surgery Clinical Trials Office (SurgCTO).
Looking to the future, Bailey envisions supporting even more divisions within the department. While their expertise is in clinical trials, SurgCTO can offer research services for grants in addition to support for investigator-initiated studies. SurgCTO manages a multitude of studies, including drug and device studies as well as the ability to provide support for Humanitarian Use Devices (HUDs). However, Bailey will not duplicate services available elsewhere at the University.
“Executing a clinical trial is a complex and underappreciated process,” says Ikramuddin. “When done poorly, it leads to poor enrollment and significant encumbrances; however, when done well, it engages the sponsor, investigator, and participants.” “No cancer,” for example, he emphasizes. “There is already a trials office for cancer, so I would refer those trials to that group.”
He is working to be able to support twice the current number of studies, but needs to have the infrastructure in place before taking on more. “We have grown from a staff of 7 in 2012 to 18 today,” he says. “As we grow, I see working not only with other divisions, but also with other departments, to provide support that they previously did not have.”
As SurgCTO continues to demonstrate improved grant management, resulting in financial savings and enhanced compliance, Bailey is planning for the next growth phase, knowing that SurgCTO services will be in even greater demand.