The current PPD PIN features sites across the US and UK, including sites at Columbia University, New York; LSU Health Shreveport; National Children’s Research Centre at Our Lady’s Children’s Hospital Crumlin, Ireland; National Institute for Health Research/Wellcome Trust Clinical Research Facility at Central Manchester University Hospitals NHS Foundation Trust, United Kingdom; NHS Research Scotland; Seattle Children’s Research Institute; Schneider Children’s Medical Center of Israel; and University of North Carolina at Chapel Hill Department of Pediatrics.
The company plans to continue to expand the network by selecting and partnering with other centers worldwide that can tap different pediatric populations and research needs.
The creation of the network comes almost two years since the US FDA announced it was cracking down on sponsors that weren’t conducting pediatric trials on time, or weren’t obtaining deferrals for such trials. The recent 21st Century Cures bill introduced in the House also calls on the NIH to begin setting up a network of pediatric trial sites that PPD might be able to help with.
“In recent years we have seen increased development in pediatric patients related both to regulatory imperatives and to increased development activity in rare diseases where children and adolescents constitute at least half of those affected,” Mark Sorrentino, executive medical director and chair of PPD’s pediatric practice, told Outsourcing-Pharma.com. “Positive changes in the global regulatory environment also have contributed to an increase in clinical trial activity. In addition, incentives such as exclusivity extensions and other initiatives like the pediatric rare disease voucher program have been contributing factors.”
PPD has conducted more than 300 pediatric studies across the past five years, and enrolled more than 180,000 children and adolescents in a variety of indications.
“Drugs intended for use in children require specific evaluation in the age groups where such use is recommended in product labels. In recent years we have seen increased development in pediatric patients related both to regulatory imperatives and to increased development activity in rare diseases where children and adolescents constitute at least half of those affected,” Sorrentino added.
“Our network already has been working effectively with our clients to provide state-of-the-art clinical trial delivery across the globe. Building formal relationships with strategically important centers that have significant pediatric clinical trial expertise, a proven track record of superior quality and the ability to recruit pediatric patients demonstrates our commitment to partnering with our clients to bring life-changing medications to market faster and at less cost.”