CTRC celebrates milestone as hub of clinical research studies at UNC

Tucked into the first floor of the Burnett-Womack building, just steps from UNC Hospitals, the Clinical and Translational Research Center (CTRC) is an unassuming spot for major advances to happen. Yet the 9,600-square-foot space acts as the physical heart of the North Carolina Translational and Clinical Sciences (NC TraCS) Institute's efforts to bridge the gap between laboratory discoveries and patient care.

This fall marks a special milestone for the CTRC, which moved into its current location on September 30, 2015.

"We are excited to recognize a decade of research, collaboration, and service in this space," said Janette Goins, director of nursing in the CTRC. Goins oversees the facility's operations, ensuring that research participants receive expert, compassionate care in a setting designed specifically for clinical studies.

"There's no FDA-approved drug or treatment out there that didn't go through research first. That's where it starts. That's what we do here."

Every month, the CTRC supports approximately 80 research protocols, nearly 200 each year. Most originate from the UNC School of Medicine, but others come from the School of Pharmacy, the College of Arts and Sciences, and the Gillings School of Global Public Health. The studies cover a remarkable range of conditions: rare genetic disorders, infectious diseases, food allergies, neurological conditions, mental illnesses, autoimmune diseases, gastrointestinal disorders, and more.

"There's no FDA-approved drug or treatment out there that didn't go through research first," said Goins. "That's where it starts. That's what we do here."

For Goins, the work is personal. Her journey into research began more than two decades ago after devastating family losses. "My sister was diagnosed with a glioblastoma at 25 and passed away a year and a half later. A few years later, my mom was diagnosed with osteogenic sarcoma, and my brother with a grade 3 astrocytoma—both of them also passed away," she said.

Both her sister and brother participated in research trials, and witnessing that hope, even in the face of grim diagnoses, inspired Goins to pursue nursing and clinical research. "Even knowing the outcomes were uncertain, there was hope that someone was working toward treatments or a cure," she said. "That hope is what's kept me in research for over 23 years."

One of the earliest and most productive programs to emerge from the CTRC has been pediatric geneticist Joseph Muenzer's research on mucopolysaccharidoses (MPS), a group of rare inherited metabolic disorders. Muenzer began his work in the 1990's through the General and Clinical Research Center (GCRC), the CTRC's predecessor, and has been instrumental in pioneering enzyme replacement therapies for MPS disorders.

Those clinical trials, many of them conducted in the CTRC, helped lay the foundation for the nationally recognized Muenzer MPS Research & Treatment Center, which opened in November 2024.

Goins recalls other breakthroughs the CTRC has made possible: a rheumatoid arthritis patient who entered a drug trial in a wheelchair and eventually walked out after her final visit only needing a cane; pediatric patients with multiple severe food allergies who were able to safely tolerate a greater exposure to their allergen without a reaction; and UNC's participation in early COVID-19 vaccine trials for Moderna and Pfizer.

"These volunteers are helping advance important research, and by treating them with care and attention, we hope they feel valued and want to stay involved..."

The CTRC also played a pivotal role in clinical trials that led to the FDA approval of several new therapies for myasthenia gravis, a rare autoimmune neuromuscular disorder. Each study has not only expanded treatment options for patients but also underscored the CTRC's role as a national leader in translating innovative science into life-changing therapies.

Much of the CTRC's work is technical—drug monitoring, data collection, patient observation, along with other minute details that move clinical trials forward. But the work can also be deeply human. Goins said that her team is "the heart of the unit"—striving to make every research participant feel welcome and respected.

"It's not like coming to a typical clinic," she said. "From the moment participants walk in, we want them to feel at ease. We take the time to get to know each person as an individual and make sure every visit is as comfortable as possible. These volunteers are helping advance important research, and by treating them with care and attention, we hope they feel valued and want to stay involved, not just in the current study, but in future ones too."

CTRC staff play a vital role in ensuring protocol adherence and participant safety, particularly in studies requiring frequent or complex interventions. In a recent CTRC survey, over 45% of respondents reported their research would not be possible without CTRC resources, and all rated the service as either "Excellent" or "Very Good," underscoring the quality and impact of the CTRC's support.

"The CTRC allows our department research to continue," wrote one respondent. "Without the facility and services, I am not sure how we would have been able to see study patients, and likely it would be at a much greater cost and would have provided fewer or less well-organized services."

"We're here to facilitate research," said Goins, who is known for her open-door policy. "We might not have every answer, but we'll help you find the person who does. We've been here long enough to usually know who does what—and if we can't help you, we can point you in the right direction."

That willingness to guide, connect, and support is part of what makes the CTRC a special place.

"We are focused on the process here, not the outcomes," Goins said. "And as long as we conduct strong studies, and get good data, the outcomes will follow."

Since moving into their current space, the CTRC has supported clinical research through:

• Collaborating with 195 investigators (from the School of Medicine, Eshelman School of Pharmacy, College of Arts & Sciences, Gillings School of Global Public Health, Adams School of Dentistry)
• Welcoming 10,738 research participants
• Enabling 785 protocols
• Facilitating 48,569 outpatient visits
• Facilitating 170 admissions (accounting for 351 bed days)
• Orienting 705 study coordinators/research assistants to the CTRC
• Accounting for 99,931 participant visit hours, reflecting the total time participants were engaged in research studies at the CTRC

…and counting!