PRA Health Sciences has launched a new site network focused on improving pediatric clinical development and access to novel medicines in this special patient population.
The new Pediatric Site Network (PSN) is a series of pediatric research centers around the world, which according to PRA, will it to improve pediatric clinical development and enhance access to novel medicines for the pediatric population.
The contract research organization (CRO) has formalized relationships with centers in the EU, US, and Israel, and has plans to expand to Latin America and the Asia Pacific.
The focal point and repository for the companys global pediatrics knowledge is its Center for Pediatric Clinical Development, it said.
PRA launched the center in May 2017, at which time the centers VP Mark Sorrentino, MD, said the next step would be to form a global network.
Operationalizing patient- and family-centered pediatric clinical trials is a complex process in that it requires careful consideration of study design and logistical challenges unique to this vulnerable population, said Kirsten Sherman Cervati, senior director, Center for Pediatric Clinical Development, lead, Pediatric Site Network.
Through our Pediatric Site Network we have opportunity to augment our existing pediatric expertise with insights from research minded thought leaders with the shared goal of advancing safe and effective treatment options within the pediatric space, she told us.
More than 70% of medications are prescribed to children off label, though demand to conduct clinical trials to address this gap has increased significantly over the past 20 years, said Sherman Cervati.
Additionally, both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published legislation requiring written plans for all medications under investigation to be assessed in children.
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