Research Center Profile:
Pediatric Clinical TrialsUnit
The Pediatric Clinical Trials Unit (PCTU) began in 1990 and is
based in the Department of Pediatrics at the University of
Louisville School of Medicine in Louisville, KY. The pediatric
faculty who serve as principal investigators have over 50 years of
collective experience in executing clinical research protocols.
Through the efforts of dedicated faculty and staff, and in
partnership with the pharmaceutical industry and community
physicians, the PCTU continues to make lasting contributions to the
health of children. Clinical research studies also benefit the
local community by offering access to vaccines and drugs not yet
available to the general public.
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. Our
investigators and staff have successfully worked with many
different sponsors and CROs.
Examples of clinical trials successfully conducted by
the PCTU include:
- Safety of a new oral rotavirus vaccine in healthy infants
- Safety and Immunogenicity of primary series and booster
vaccines for infants, children, adolescents and adults
- Safety and immunogenicity of new combination vaccines in
infants and children
- Concomitant use vaccine studies in infants, children, and
adolescents
- Dose ranging study of a new form of M-M-R vaccine
- Formula studies in healthy infants
- Safety and efficacy of oral anti-infectives to treat acute and
chronic infections
- RSV prophylaxis for at-risk infants
- Drug studies for children with a variety of childhood
illnesses
Pediatric studies are conducted in three faculty-run primary
care clinics, two of which (Children and Youth Project and
University Child Health Specialists) serve an inner city population
and one of which serves a mixed suburban/rural population
(University Child Health Specialists South). The total number of
newborns seen in these clinics approximates 120 per month, with a
total number of children assigned to these clinics is close to
20,000. Our research staff has 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; two of the clinics are
adjacent to the medical school and all are close to a large
undergraduate campus.
Dr. Gary S. Marshall
Director, Pediatric Clinical Trials Unit
Director, Division of Pediatric Infectious Diseases
Professor of Pediatrics
Dr. Marshall has been involved in pediatric clinical trials since
the inception of the PCTU in 1990.
Dr. Kristina K. Bryant
Assistant Professor of Pediatrics
Dr. Bryant has been conducting pediatric clinical research since
1998.
Dr. Charles R. Woods
Professor of Pediatrics
Pediatric Infectious Diseases
Dr. Woods has been involved in pediatric clinical research since
1991.
The general pediatric faculty at each of the clinics are
sub-investigators for all studies and have served as principal
investigators for a variety of general pediatric studies.
Natalie Pasquenza, RN, CCRC
Research Nurse Manager
4 years of pediatric research experience
Coordinators:
Gena Sayat, RN, CCRC
Research Nurse
6 years of pediatric research experience
Freda Davis, RN
Research Nurse
2 years of pediatric research experience
Mechelle Stoner, RN
Research Nurse
1 year of pediatric research experience
Assistants:
Penny Scott, MA
5 years of pediatric research experience
Jenny Willis,MA
1 year of pediatric research experience
Natalie Pasquenza, RN,CCRC
Research Nurse Manager
Pediatric Clinical TrialsUnit
555 South Floyd Street
Louisville, KY 40202
USA
Phone: 502-852-6854
Fax: 502-852-1523
EMail: napasq01@louisville.edu
If you are interested in contacting this center to discuss placing a clinical
trial there, please complete and send the E-mail form below. A representative from
the research center will then follow up with you.
