Across the country, a growing bottleneck exists in delivering new therapies to children. Clinical trials for pediatric patients are especially complex, requiring specialized facilities, multidisciplinary expertise, and strong institutional commitment. Few organizations are capable of handling that complexity. Lurie Children’s is one of them. Our mission and structure are built for this purpose: translating discoveries into care and turning research into real opportunities for children and families.
At the heart of that effort is our Clinical Research Unit (CRU) on the 19th floor of Lurie Children’s. This dedicated space provides the infrastructure that enables human-subject research, including core equipment and technologies for clinical studies, comprehensive nursing services, pharmacy and laboratory expertise, eight outpatient rooms, six inpatient beds, private meeting areas, and specialized support for data collection and overnight monitoring. Being within the hospital ensures direct access to emergency services, intensive care, imaging, and other subspecialties essential for participant safety.
The CRU supports a remarkable range of studies. As Katie Sparks, CCRP, Director of Clinical Research Services in the Office of Clinical and Community Trials, explains, it serves as a shared resource across the institution, including innovative gene and cellular therapy trials for rare diseases, several of which have led to FDA-approved treatments. In fiscal year 2025 (September 1, 2024–August 31, 2025), the CRU supported 144 active studies, with 68 more in development, across 22 divisions, and hosted 2,554 participant visits. These numbers reflect not only scale, but the dedication required to give children access to potentially life-changing therapies.
Emily Collick, BSN, RN,
and Kathleen Moran, BSN, RN, CPN
Clinical trial success depends on teamwork. Under Dhey McClure, RN, CCRN, Associate Director of Clinical Research Support Services, the CRU connects investigators with a network of clinical and operational experts. Katie Keeley, MPH, CCRP, leads efforts to ensure transparency and efficiency in operations, and Molly Gallivan, Research Project Manager, develops study budgets and logistics. Meera Sotor, MPH, BSN, RN, manages a skilled nursing team—Emily Collick, Deniz Evangelista, Margaret Grace, Christine Molina, Kathleen Moran, Susan Rapp, Lauren Tresley, and Rachel Wimsatt—who provide expert, compassionate care. Krystal Baker, Patient Service Representative II, greets families and helps create a warm, welcoming environment.
The Investigational Drug Service Pharmacy, led by Ami Patel, PharmD, Yoomi Lee, PharmD, Tara Mongkolpradit, PharmD, and Denise Rizzo, PharmD, with technicians Sonny Sherwood and Myra Barrett, ensures that every investigational drug used in trials is prepared and delivered safely, often directly from the adjacent pharmacy to the bedside. The CRU team also works closely with many essential ancillary services, such as medical imaging, ophthalmology, neuropsychology, and physical-occupational therapy, whose expertise enables the precise assessments and monitoring required in pediatric trials. Behind every study are also the investigators, data managers, regulatory and compliance specialists, administrative staff, and, most importantly, the children and families who volunteer to participate. Together, they make discovery possible.
Dedicated clinical research units like ours are rare in pediatric medicine. Having this space and the expertise to support it allows Lurie Children’s and Manne Research Institute to bring leading-edge treatments to children who might otherwise not have access to them. Every study, every patient visit, every precise test, and every carefully delivered dose moves us closer to a healthier future for children everywhere.
