Michelle Tomasino is the clinical trials manager in the Division of Research. She has worked at ÐÔÊӽ紫ý for five years, starting a couple of months before the Kirk Kerkorian School of Medicine opened on July 1, 2017.
She oversees the clinical trials office, managing its education and outreach, compliance, and contract and budget negotiations on interventional research. During the pandemic, the office focused on COVID trials but now as those trials close, Tomasino says the focus is shifting back to comprehensive community needs that target many different areas and populations here in Nevada.
Tell me about the current clinical trials at ÐÔÊӽ紫ý.
We’ve been consistently growing clinical trials and working on making them logistically feasible, ensuring our community has opportunities to be a part of advanced medicine. Some of the unique clinical trials currently in place include a study utilizing stem cells for the treatment of complex perianal fistulas, the Cologuard 2.0 for colorectal screening, and a study targeting atherosclerotic cardiovascular disease, chronic kidney disease, and systemic inflammation.
How is research used by the medical school?
Clinical trials help every aspect of the institution, particularly the School of Medicine. Doctors can better understand and appreciate medical science and develop a greater ability to decipher research findings and papers. The trials support critical thinking, develop teamwork skills, and increase exposure to the best clinical minds. Exposure and experience to industry-sponsored clinical trials increase the ability for faculty and clinicians to collaboratively write their own interventional research.
How are the participants selected? What is the benefit to them?
Our clinical research staff members, Kathy Mendez and Kemi Otitujo, do a cursory review of potential participants and the investigator or co-investigator propose the study to the potential participant. If the participant agrees and signs consent, they are screened based on the eligibility of the protocol requirements. Most often, participants are specifically told there is no direct benefit to them for participating, but there are rare moments that participants positively respond to interventional research.
How do you balance your time and efforts working with both the Division of Research and the medical school?
I work mainly at main campus; however, I find myself spending one to two days a week working directly with the research staff at the Kirk Kerkorian School of Medicine. We manage the current clinical trial workload and analyze sponsor pipelines to increase the interventional research opportunities.
How has your role evolved since you came to ÐÔÊӽ紫ý?
When I started in this role, I was given a blank canvas to begin foundationally supporting clinical trials. The clinicians transitioning to ÐÔÊӽ紫ý’s School of Medicine from the University of Nevada, Reno needed to have their current clinical trials assessed. I evaluated each study’s shelf life, local feasibility needs, and began contracting research vendors.
We now have collaborating efforts from different departments working together on sponsor-funded clinical trials and I continue to hold educational classes for potential principal investigators so we can continue to expand our portfolio. Kathy Mendez and Kemi Otitujo, clinical research coordinators at the school, execute the regulatory and participant management of all the trials. They also liaison between sponsors and investigators as the necessary support staff needed to manage all the research.
The current portfolio for clinical research support now includes UMCSN, Sunrise, Desert Radiology, ExamOne, LMC Pathology, CPL Laboratories, ophthalmologists, and several different central Institutional Review Boards (IRBS). We’ve established a clinical trials management system, a billing process, and are expanding the office with additional positions.
What challenges do you face as the office for clinical trials grows?
Clinical research in general right now is facing high turnover in personnel. It takes about three to five months to train team members in current research trials, standard operating procedures, and managing communication between (the principal investigator) and sponsors. As we continue to grow here at ÐÔÊӽ紫ý, I hope we are able to maintain longevity in clinical trial staff.
What do you like about living in Vegas?
The greatest part about Las Vegas is the weather — and the many tourist attractions here are a great incentive for my Midwest family and friends to visit often. My family and I also love hiking around the valley and at nearby national parks.
