New National Program to Study and Establish Pediatric Dosing

KANSAS CITY, Mo., Oct. 1 /PRNewswire/ -- A new national initiative, the Pediatric Trials Network (PTN), was created this week with a $95 million grant supported by the National Institutes of Health (NIH).  The PTN will be led through collaboration between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and several of the country's preeminent pediatric medical centers, including Children's Mercy Hospitals and Clinics.  

Gregory L. Kearns, PharmD, PhD, Chairman of the Department of Medical Research at Children's Mercy, will serve as a co-principal investigator for the PTN along with Daniel Benjamin, Jr., MD, PhD of Duke University, and will direct the clinical pharmacology initiatives.  

"Over the past decade and a half, research completed by the pediatric clinical pharmacology program at Children's Mercy has provided firm proof-of-concept that the best of science and technology can be incorporated into the design of necessary clinical trials of medications in children," explained Dr. Kearns. "These accomplishments have provided a cornerstone which in large measure has enabled the birth of the new Pediatric Trial Network."

The vast majority of drugs approved for the treatment of children have not been tested in children, and less than 20 percent of these drugs are labeled for pediatric use. The PTN will use data collected to help inform pediatric drug labeling, providing valuable new information about medical treatments of children to regulators and pediatricians.

Over the next seven years, it is projected that the PTN will focus on the study of therapeutic drugs identified by NICHD through its "Best Pharmaceuticals for Children" initiative as being priority compounds for pediatric use. This will include the research of medical devices and drugs for cardiovascular diseases, cancer, infectious diseases, gastroenterology, respiratory diseases and neonatology targeted for the treatment of infants and children.

The other core members of the PTN will include Duke University; the University of California, San Diego; Children's National Medical Center; The Children's Hospital of Philadelphia; Wake Forest University Baptist Medical Center; and Carilion Clinic Children's Hospital and the Virginia Tech Carilion School of Medicine.

The PTN will consist of six groups dedicated to the study and safety of pediatric dosing including clinical operations and program management; clinical pharmacology; pharmacokinetic and pharmacodynamics; safety reporting and ethics review; multi-disciplinary development of devices; and training.  

The project's primary objective is to create a fully integrated network capable of working in partnership with both NICHD and the U.S. Food and Drug Administration to facilitate pediatric drug development from inception through study execution and regulatory submission. The PTN will consist of more than 100 participating clinical institutions, all of which will provide sites where pediatric trials can be performed safely and to the highest standards.  

About Children's Mercy Hospitals and Clinics

Children's Mercy Hospitals and Clinics, located in Kansas City, Mo., is one of the nation's top pediatric medical centers. The 314-bed hospital provides care for children from birth through the age of 18, and has been recognized by the American Nurses Credentialing Center with Magnet designation for excellence in nursing services, and ranked by U.S. News & World Report as one of "America's Best Children's Hospitals." Its faculty of 600 pediatricians and researchers across more than 40 subspecialties are actively involved in clinical care, pediatric research, and educating the next generation of pediatric subspecialists. For more information about Children's Mercy and its research, visit childrensmercy.org. For breaking news and videos, follow us on Twitter, YouTube and Facebook.

SOURCE Children's Mercy Hospitals and Clinics

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