Pharmaceutical Product Development (PPD) has launched a new, eight-site global pediatric investigator network with the goal of leveraging early investigator input, accelerating the trial startup process and improving patient enrollment.
PPD stated that the network is comprised of world-renowned centers of excellence. The CRO added that it will offer the eight member sites a steady stream of study opportunities as well as operating processes and technology solutions.
The eight sites in the PPD pediatric investigator network include Columbia University, New York; Louisiana State University (LSU) Health Shreveport; the University of North Carolina (UNC) at Chapel Hill, department of pediatrics; Seattle Children’s Research Institute; National Institute for Health Research/Wellcome Trust Clinical Research Facility at Central Manchester University Hospitals, U.K.; NHS Research, Scotland; Children’s Research Center at Our Lady’s Children’s Hospital, Crumlin, Ireland; and the Schneider Children’s Medical Center of Israel.
“The key is the quality of the sites, not the quantity of sites,” said Mark Sorrentino, M.D., executive medical director and chairman of PPD’s pediatric practice area. “Our growth will be measured and deliberate, only partnering with sites that can best support the pediatric trials of our clients.”
PPD may add more investigative sites as part of a controlled expansion of the network if the sites align with particular pediatric populations and new research needs. Over the past five years, PPD has conducted more than 300 studies and enrolled more than 180,000 children and adolescents in a wide variety of pediatric indications.
The formation of a pediatric network comes as biopharmaceutical companies are under greater pressure globally to conduct larger numbers of trials among pediatric patients more effectively. Many rare diseases disproportionately affect children. Site identification and engagement in pediatric settings is characterized as highly inefficient. Recruiting patients for pediatric clinical trials also can be particularly problematic, contributing to substantial clinical trial delays. Moreover, in the U.S., pediatric versions of new medications often are completed about nine years after the adult version gains FDA approval—a gap that the PPD network hopes to help narrow.
“We’re hoping to get that gap down to two to three years. There needs to be more planning and input as pharmaceutical companies are interested in developing new protocols for pediatric studies where they can get ideas and early feedback where possible,” said John Vanchiere, M.D., Ph.D., chief of pediatric infectious diseases and vice chairman for pediatric research at LSU. “We have blanket confidentiality agreements with PPD and through this network it saves us two weeks of not having to do new agreements with sponsors. With this network, there is uniformity in how to capture data and make monitoring of the study and enrollment much more efficient.”
Vanchiere said reviewing a pediatric protocol and deciding whether to do the clinical trial can take 48 to 72 hours, adding that LSU will do between 12 and 15 infectious disease trials in children this year along with vaccine studies. PPD has brought to LSU 10 studies in the past 10 weeks.
Jake Lohr, M.D., director of the clinical trials initiative at the UNC’s department of pediatrics, said he looks forward to partnering with other major pediatric sites and to reducing the gap in the availability of children’s versions of new adult medications.
“What I like is the openness where we can discuss a protocol that is not in its final form and make suggestions to get certain things done without altering the fundamental approach of the study, but rather how best it can be accomplished in a clinical setting,” said Lohr.
“[The network] gives us a wider portfolio of trials across different pediatric therapy areas than was possible before its formation,” said Professor Nick Webb, M.D., honorary professor of pediatric nephrology at the University of Manchester in the U.K. and a consultant pediatric nephrologist at the Royal Manchester Children’s Hospital. “Having a memorandum of understanding with PPD means the whole process of signing up clinical trials is easier with multiple studies through a single organization.”
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