The institutional review board (IRB) service provider will work with the Institute for Advanced Clinical Trials (I-ACT) for Children as it grows its trial site network, which currently includes 44 pediatric research sites in the US.
I-ACT for Children aims to accelerate biomedical innovation for child-centered clinical trial networks and stakeholders to accelerate site startup and completion of global pediatric studies. Pat Donnelly, CEO of Advarra told us that the network is focusing specifically on pediatrics to accelerate the establishment of safety and effectiveness data for approved and unapproved treatments.
Which Laura Gordon, CEO of I-ACT for Children, said in a statement that providing central IRB services as part of the site network is an imperative aspect of making pediatric trials more efficient.
He added that the network is continuing to add patients, investigators, and caregivers to provide independent guidance on developing the most respectful pediatric plans and protocols possible.
The US Food and Drug Administration (FDA) requires specific additional protections to be considered in pediatric trials, “this includes determining the specific level of risk presented, the prospect of direct benefit, and determining whether assent is necessary, and if so, how it’s documented,” said Donnelly.
