The NICHD established the PPRU Network in 1994 to facilitate and promote pediatric labeling of new drugs or drugs already on the market by fostering cooperative and complementary research efforts among academia, industry, and health care providers. The PPRU Network sunsetted in 2010 and is no longer active. This information is intended for reference and historical purposes.
The PPRU Network was initially housed within the NICHD’s Endocrinology, Nutrition, and Growth Branch until the Obstetric and Pediatric Pharmacology (OPP) Branch was created in 2004.
Between 1994 and 2008, the PPRU Network grew from 7 to 13 sites at universities and children’s hospitals around the country, and its focus broadened as well. Initially, the PPRU Network’s research priority was to conduct clinical trials that would lead to pediatric labeling of pharmaceuticals commonly used off-label to treat children. PPRU researchers also contributed to advances in pediatric research through the development and validation of new basic and preclinical research models, biomarkers, study designs, and drug-delivery systems.
Later, the Network pursued a more comprehensive program in developmental and pediatric clinical pharmacology that included basic and translational research—such as patient-oriented therapeutics and drug response studies—on pharmaceuticals. The Network encouraged efficient and effective use of its data through the PPRU Clinical Data Repository, which stored all investigator-initiated study data using a common set of terms and definitions, allowing data sharing and metadata analysis. The Network also trained new investigators in pediatric pharmacology through the Mentored Scientist/Clinical Investigator Development Award (U10) mechanism.
The PPRU Network was governed by a Steering Committee of the principal investigators (PIs) from the units and the NICHD program officer. The Steering Committee was chaired by an independent investigator and a liaison from the Food and Drug Administration served as a consultant on regulatory issues. In addition, each PPRU included a PI, a team of pharmacologists and clinical investigators, a data coordinator and other specialists, and a core analytical and biomedical laboratory.
Activity in the PPRU Network continued until 2010 through no-cost extension mechanisms. For more information on the PPRU Network, visit the PPRU Network Legacy Web site at http://www.ppru.org/Default.aspx .
The overall goal of the PPRU Network was the safe and effective use of drugs in children.
The PPRU Network also:
- Conducted studies on the pharmacokinetics and pharmacodynamics of drugs in children
- Provided a home for pre- and post-marketing clinical trials in children conducted by pediatric clinical pharmacologists in collaboration with the pharmaceutical industry and contract research organizations
- Served as an advisory body to the pharmaceutical industry, regulatory agencies, health professionals and the public on the appropriate use of drugs in children
Network activities included: Preclinical and Phase I studies, such as bioavailability and bioequivalence, developmental pharmacogenetics, in vitro assessment of metabolite-mediated cellular injury; pharmacokinetics modeling, and pharmacodynamics; Phase II and III studies, such as hospital inpatient studies and ambulatory care studies; and Phase IV studies, such as post-marketing study designs, laboratory/assay specialization, small volume sample drug and metabolites analysis, core molecular pharmacology laboratory, and antiviral drugs assays.
Studies addressed many therapeutic categories, including (but not limited to): behavioral medicine, cardiology, endocrinology, gastroenterology, infectious diseases, hematology, hypertension, immunology/allergy, immunopharmacology, metabolism, neurology, pain management, oncology, nephrology, pulmonology, and psychiatry.
The PPRU Network is no longer active. For a listing of sites that took part in the PPRU Network, visit http://www.ppru.org/sites.aspx .