Johns Hopkins All Children’s Hospital has joined the Institute for Advanced Clinical Trials (I-ACT) for Children, an independent, nonprofit organization that seeks to accelerate biomedical innovation in pediatrics.
Created by a consortium that included the American Academy of Pediatrics and the Critical Path Institute, I-ACT for Children builds collaboration among like-minded institutions, clinical trial sponsors, regulators and other stakeholders to promote innovation, quality and efficiency in pediatric clinical trials. I-ACT, which formally launched in 2017, has built a pediatric trial-site network of 29 sites, including the Johns Hopkins Children’s Center in Baltimore, and expects to have 40 by the end of 2018. The site network includes many of the most prestigious children’s hospitals in the country; 2019 plans include the addition of 20 U.S. sites and at least five international sites.
“Children of all ages deserve innovative medical therapies that are developed with the same level of urgency, quality and commitment afforded adults, and I-ACT was created to support that goal,” I-ACT for Children CEO Laura Gordon says. I-ACT Vice President Lisa Benson, who oversees I-ACT’s trial-site network, added, “Johns Hopkins All Children’s and the other members of our site network have both the field-leading experience and the robust facilities for the innovative and efficient conduct of clinical trials in children. I-ACT creates a collaborative structure to help our site network share best practices, identify unmet therapeutic needs and efficiently execute clinical trials.”
Johns Hopkins All Children’s conducts or participates in more than 350 studies focused on infants and children and leads multicenter trials such as Kids-DOTT, a National Institutes of Health (NIH)-funded phase 3 trial that focuses on optimizing the treatment for venous thrombosis (blood clots in the veins) in children. In September, the hospital opened a $95 million, 225,000-square-foot Research and Education Building, including an expansion of Florida’s only College of American Pathologists-accredited biorepository devoted to pediatric research. The new facility is designed to promote collaboration among clinical, translational and basic scientists and clinicians. Johns Hopkins All Children’s will hold its Seventh Annual Research Symposium there on Oct. 19.
“Johns Hopkins All Children’s and I-ACT share a passion for enhancing the quantity and quality of clinical trials across the pediatric health spectrum, to fulfill a critical need for greater evidence on safety and efficacy of medications and medical devices in children” says Neil Goldenberg, M.D., Ph.D., an NIH-funded pediatric clinical trialist who serves as director of research at the hospital and a professor of pediatrics and medicine in the Johns Hopkins University School of Medicine. Goldenberg, Johns Hopkins All Children’s director of research operations Frances Hamblin, MSHS, R.N., CCRP, and manager of research regulatory affairs and quality assurance Heather Cronin, M.Sc., have been selected to serve on I-ACT committees to lend expertise in trial design and execution and to share experiences and innovative practices with other members.
“By working together,” Goldenberg adds, “we and other I-ACT network sites, along with pediatric leaders from the pharmaceutical industry and FDA, will achieve a common goal of accelerating the availability of ever-better disease treatment and prevention options for children.”