I-ACT for Children's COVID-19 Emergency Access Program launched to accelerate pediatric trials

As the number of children with severe COVID-19 illness grows, there is increasing urgency to ensure that potential treatments and vaccines are tested for safety and efficacy in children. Today, the Institute for Advanced Clinical Trials (I-ACT) for Children announced the launch of its COVID-19 Emergency Access Program, which allows companies to access the organization's trial-planning experts and pediatric trial network to accelerate the development of pediatric COVID-19 treatments and vaccines.

The immediate research focus has rightly been on the adults who make up the majority of severe COVID-19 cases, but we cannot neglect the needs of children who are becoming seriously ill with COVID-19. We must ensure that as treatments and vaccines are developed, children are included in clinical trials so that they can benefit from advances just as adults do."

Gary Noel, M.D., I-ACT for Children Chief Medical Officer

I-ACT for Children is a non-profit organization that offers independent expert guidance to drug developers and others to accelerate and enhance the quality of pediatric clinical trials.

The launch of I-ACT for Children's COVID-19 Emergency Access Program allows any company developing COVID-19 treatments and vaccines, including non-members, to use the organization's pediatric research network to conduct their pediatric clinical trials.

In early April, the Centers for Disease Control and Prevention (CDC) reported that in the United States, about 1.7 percent (2,572 out of 149,082 cases for which age was reported) of COVID-19 cases had occurred in children (< 18 years). Of those, 5.7 percent were hospitalized, compared with 10 percent of adults at that time. COVID-19 has led to serious illness and death in children ranging from newborns and young infants to those with underlying medical conditions.

Under the new emergency access program, non-member companies will be able to work with I-ACT for Children to plan and execute COVID-19 clinical trials and access a global research network designed to generate regulatory-grade scientific data. I-ACT for Children's COVID-19 Team has deep expertise and public- and private-sector experience in the critical elements of pediatric drug and biologics development, including specialty expertise in infectious disease, assessment of products for respiratory viral diseases and pediatric, newborn and maternal pharmacology.

The I-ACT for Children Site Network includes 62 sites in the United States, Australia and Saudi Arabia and has agreements in place with European and Canadian sites to support global trials. The organization has organized a subset of sites within this network that:

• Are geographically located where COVID-19 cases are more concentrated
• Have deep expertise in infectious disease
• Are linked to scientists who have made important contributions to the understanding of respiratory viral diseases
• Have ready access to healthy patients for conducting vaccine trials

Drug development in pediatrics has historically been slow and inefficient and most medicines prescribed for children have never been proven effective for them. I-ACT for Children was created to level the playing field by championing and participating in the research needed to ensure children have the same access as adults to effective medicines.