In 1994, Arkansas Children’s Hospital (ACH) was selected as a site for one of seven original Pediatric Pharmacology Research Units (PPRUs) funded by the National Institute for Child Health and Human Development (NICHD). These centers were established in response to concerns that many medications commonly used to treat a variety of childhood illnesses have not undergone carefully controlled clinical trials to establish safety and effectiveness in children. Approximately 75% of all currently marketed prescription drugs have never received approval for use in children from the U.S. Food and Drug Administration. To address this problem, the PPRU Network focuses on studies which result in expanded pediatric labeling for drugs which are under investigation or have been recently marketed. Since its inception, the ACH PPRU has participated in more than 60 pre- and post-marketing clinical trials, including antiviral, antibiotic, antifungal, antihypertensive, anti-inflammatory, sedative-hypnotic, proton pump inhibitor, and histamine-2 antagonist studies. In 1999, the network expanded to 13 sites and broadened its mission to include translational research and comparative trials. The ACH PPRU was awarded funding for five additional years beginning in 2004.
Pediatric patients from newborn to 18 years of age have completed studies lasting from a few hours to one month in duration. The majority of these studies involve collection of blood or other fluid samples to develop unique pediatric pharmacokinetic and pharmacodynamic profiles. With vast experience in designing and conducting pediatric trials, the PPRUs are able to offer practical assistance emphasizing study design, methods for successfully recruiting and enrolling patients, minimizing unnecessary or impractical interventions, and collecting reliable data.