Pediatric Trials Network

Pediatric Trials Network
Name	Pediatric Trials Network
Formation	2010
Type	Research consortium
Headquarters	Cincinnati, Ohio
Leader title	Principal Investigator
Leader name	Michael Cohen-Wolkowiez

Pediatric Trials Network The Pediatric Trials Network is a multicenter clinical research consortium focused on improving pediatric pharmacotherapy through clinical trials, pharmacokinetics, and pharmacodynamics studies. It collaborates with academic medical centers, federal agencies, and patient advocacy organizations to evaluate drug dosing, safety, and efficacy for infants, children, and adolescents. The consortium integrates expertise from neonatology, pediatric infectious diseases, pediatric pharmacology, and pediatric critical care to translate evidence into prescribing guidance.

Overview

The network brings together investigators from Cincinnati Children's Hospital Medical Center, Baylor College of Medicine, Children's Hospital of Philadelphia, Johns Hopkins University School of Medicine, Stanford University School of Medicine, University of California, San Francisco, University of Pennsylvania Perelman School of Medicine, Washington University in St. Louis, Children's National Hospital, Vanderbilt University Medical Center, University of Michigan Medical School, Massachusetts General Hospital', Duke University School of Medicine, Boston Children's Hospital, Columbia University Irving Medical Center, Yale School of Medicine, University of North Carolina at Chapel Hill School of Medicine, University of Pittsburgh School of Medicine, Emory University School of Medicine, University of Utah School of Medicine and other clinical sites. It aligns with federal programs including the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act, the National Institutes of Health, the U.S. Food and Drug Administration, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Collaborations extend to professional societies such as the American Academy of Pediatrics, the Society for Pediatric Research, the American Society for Clinical Pharmacology and Therapeutics, and advocacy groups like March of Dimes.

History and Funding

The consortium was established with funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and cooperative agreements involving the National Institutes of Health. Early leadership included investigators with affiliations to Cincinnati Children's Hospital Medical Center, Vanderbilt University Medical Center, and Baylor College of Medicine. Major funding mechanisms referenced include cooperative clinical trial awards from the National Institutes of Health and support from the U.S. Food and Drug Administration for pediatric drug studies under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The network has received supplemental grants tied to initiatives from Centers for Disease Control and Prevention partnerships and collaborative projects with foundations such as Robert Wood Johnson Foundation and Gates Foundation for global neonatal pharmacology. International collaboration has connected the consortium with institutions like University College London, Great Ormond Street Hospital, Karolinska Institutet, University of Toronto, and McMaster University.

Research Focus and Key Studies

Primary research themes include neonatal pharmacokinetics, antibiotic dosing, antiviral studies, antifungal therapy, analgesia, sedation, and therapeutic monitoring in pediatric critical care. Key studies have included multicenter evaluations of amikacin and vancomycin dosing in neonates, pharmacokinetic assessments of oseltamivir and acyclovir in infants, and trials addressing fluconazole prophylaxis for fungal infections in preterm infants. The network has published data influencing labeling for drugs reviewed by the U.S. Food and Drug Administration and informed practice guidelines from the American Academy of Pediatrics and Infectious Diseases Society of America. Trials have intersected with work on neonatal sepsis, studies relevant to respiratory syncytial virus, and investigations into dosing for antiretroviral agents tied to Pediatric HIV programs. Collaborative projects have linked to registries and cohorts such as Neonatal Research Network, Vermont Oxford Network, and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network.

Network Structure and Participating Sites

The consortium operates via a central coordinating center housed at Cincinnati Children's Hospital Medical Center with partnering clinical sites across pediatric centers including Children's Mercy Kansas City, Hassenfeld Children's Hospital at NYU Langone, Ann & Robert H. Lurie Children's Hospital of Chicago, Riley Hospital for Children at Indiana University Health, Seattle Children's Hospital, Rady Children's Hospital-San Diego, St. Louis Children's Hospital, Rainbow Babies & Children's Hospital, University of Colorado School of Medicine, Children's Hospital Colorado, University of Wisconsin School of Medicine and Public Health, Oregon Health & Science University School of Medicine, University of Iowa Hospitals and Clinics, University of Arizona Health Sciences, SUNY Upstate Medical University, Medical University of South Carolina, University of Rochester Medical Center, University of Florida College of Medicine, University of Kentucky College of Medicine, and international collaborators at Auckland City Hospital and Royal Children's Hospital, Melbourne. Governance includes a steering committee, data safety monitoring boards, and principal investigators affiliated with institutions such as Yale School of Medicine and Duke University School of Medicine. Regulatory oversight interfaces with the U.S. Food and Drug Administration and institutional review boards at participating hospitals.

Data Management and Ethics

Data coordination uses secure platforms aligned with standards promoted by the National Institutes of Health and the U.S. Food and Drug Administration for clinical trial data. The network adheres to ethical frameworks advanced by bodies such as the American Academy of Pediatrics Committee on Bioethics and institutional review processes at sites including Children's Hospital of Philadelphia and Boston Children's Hospital. Pharmacovigilance and safety monitoring engage experts from Johns Hopkins University School of Medicine and Stanford University School of Medicine and conform to reporting expectations of the U.S. Food and Drug Administration. The consortium emphasizes informed consent, assent processes influenced by guidance from Council for International Organizations of Medical Sciences and bioethics scholarship from Harvard Medical School. Data sharing and secondary analyses collaborate with repositories and initiatives such as the National Database for Clinical Trials Related to Mental Illness framework adaptations and partnerships with Duke Clinical Research Institute.

Impact on Pediatric Clinical Practice

Findings from the network have informed dosing recommendations cited by the American Academy of Pediatrics, labeling updates by the U.S. Food and Drug Administration, and guideline revisions from specialty societies including the Infectious Diseases Society of America and the Society of Critical Care Medicine. Outcomes have influenced neonatal antimicrobial stewardship programs at centers like Vanderbilt University Medical Center and Cincinnati Children's Hospital Medical Center and contributed to global neonatal care efforts with partners such as WHO-affiliated initiatives and UNICEF-linked perinatal programs. The consortium's work has been integrated into educational activities at academic centers including Harvard Medical School, Johns Hopkins University School of Medicine, Stanford University School of Medicine, and University of California, San Francisco, and continues to shape research agendas supported by the National Institutes of Health and philanthropic funders like Robert Wood Johnson Foundation.

Category:Pediatric research networks