The Pediatric Clinical Trials Unit (PCTU) is based in the Department of Pediatrics at the University of Louisville School of Medicine in Louisville, Kentucky. The pediatric faculty who serve as principal investigators have over 50 years of collective experience in executing clinical research protocols. Areas of special interest include phase II, III and IV vaccine studies in children and adults, as well as outpatient anti-infectives and other general pediatric protocols. The unit is affiliated with Kosair Children's Hospital, a 270-bed, full-service teaching hospital serving the nearly 500,000 children of central and western Kentucky and southern Indiana.
Pediatric studies are conducted in two faculty-run primary care clinics, which serve an inner city population (Children and Youth Project and .) The total number of newborns seen in these clinics approximates 120 per month, and the number of children assigned to these clinics is close to 20,000. The research staff have permanent offices in each clinic with direct access to patients, and subject recruitment and retention is excellent. The hospital and clinics are located in Louisville within 15 minutes of the airport, are adjacent to the medical school and are close to a large undergraduate campus.