According to a study published in 2016, pediatric clinical trials are failing to inform science. However, the industry has responded with an increase in resources dedicated to pediatric drug development, according to an analysis completed by the Tufts Center for the Study of Drug Development.
Today, Worldwide Clinical Trials and KinderPharm – a US-based pediatric drug development contract research organization (CRO) – have announced the formation of a center of excellence for pediatric drug development and clinical research.
Worldwide Clinical Trials, a CRO headquartered in Morrisville, NC, has clinical operations and medical and scientific personnel across more than 60 countries.
"Pediatric research is challenging, takes longer to recruit subjects, and costs more per subject than adult trials," said Dave Bowser, executive vice president and general manager of global clinical development at Worldwide Clinical Trials.
"Worldwide and KinderPharm are changing that paradigm," he told us. "Pharmaceutical sponsors now have the solution to seamlessly conduct all aspects of pediatric drug development – from inception of the initial regulatory plan to the conduct of clinical trials – on an international basis."
According to Worldwide, the services will be led by a team of pediatricians, clinical/medical monitors, regulatory affairs professionals, non-clinical scientists, program managers, statisticians, rare disease specialists, and pharmacokineticists.
Worldwide last month announced its acquisition of Continuum Clinical’s Late Stage research practice. The deal expanded Worldwide’s observational research study services and added health economics outcomes research (HEOR) and patient registry capabilities.