The Pediatric Clinical Trials Unit (PCTU) is based in the Department of Pediatrics at the University Of Louisville School Of Medicine, which is affiliated with Norton Children’s Hospital, a 280-bed, free-standing, full-service teaching hospital serving the nearly 500,000 children of central and western Kentucky and southern Indiana. The hospital and clinics are located in Louisville, Kentucky, within 15 minutes of an international airport. The campus includes medical, dental and nursing schools. A large undergraduate campus is close by.
The pediatric faculty who serve as investigators have over 100 years of collective experience in executing clinical research protocols. Areas of special interest include Phase 2, 3 and 4 vaccine studies in children and adults, as well as outpatient studies of anti-infectives and other investigational protocols. The PCTU’s coordinators are registered nurses with bachelor’s degrees and research certification.
Pediatric studies are conducted in the faculty-operated UofL Pediatrics primary care clinics. The patient population is ethnically diverse and includes inner city and suburban populations as well as many Spanish-speaking families. The total number of newborns seen in these clinics approximates 80 per month and the total number of children assigned to these clinics is close to 17,000. The research staff have permanent offices in each clinic with direct access to patients and medical records, allowing research to be done in the context of a medical home—research nurses and pediatricians to work together, eliminating the need for referrals as the recruitment model. As a result, subject recruitment is excellent.
In partnership with the pharmaceutical industry and community physicians, the PCTU has made lasting contributions to the health of children, and clinical research studies have benefited the local community by offering access to agents not yet available to the general public. Many of the vaccines that are part of the routine childhood immunization schedule were studied in the PCTU before or shortly after licensure, including vaccines against rotavirus, pertussis, human papillomavirus, pneumococcus, and meningococcus, as well as novel combination vaccines (see list of publications below). Protocols have included dose-ranging, lot-to-lot comparison, safety, immunogenicity, and concomitant use outcomes. Other research conducted in the PCTU includes formula studies in healthy infants, safety and efficacy of oral anti-infectives for acute and chronic infections, passive immunization against respiratory viral pathogens and natural history studies. Additional interests include seasonal allergies, asthma, infant colic and other pediatric illnesses/conditions that are often treated and followed by family pediatricians.
Since 1990, the PCTU has enrolled more than 3,600 subjects in more than 100 different studies sponsored by various pharmaceutical partners (see list below). Sponsors who are looking for successful pediatric research sites are encouraged to call Dr. Marshall or Natalie Pasquenza. Contact information is included at the end of this document. Parents and patients interested in learning about research opportunities may call as well.