KU Medical Center awarded $31 million to facilitate pediatric clinical trials across network of 18 rural and underserved sites

The University of Kansas Medical Center has been awarded a five-year, $31 million grant from the National Institutes of Health (NIH) to coordinate clinical trials for infants and children in rural and underserved areas. The grant, awarded earlier this month, is the largest five-year award in the history of KU Medical Center and one of the largest such awards ever received at the University of Kansas.

In partnership with the University of Nebraska Medical Center (UNMC), KU Medical Center will serve as the Data Coordinating and Operations Center (DCOC) for the Environmental influences on Child Health Outcomes (ECHO) Institutional Development Award (IDeA) States Pediatric Clinical Trials Network.

“KU Medical Center has been building the biostatistics and informatics infrastructure necessary for the DCOC for 20 years,” said Matthew Mayo, Ph.D., founding chair of the Department of Biostatistics and Data Science at KU Medical Center and the lead investigator on the grant. “The ultimate goal is to support high-quality, multi-center trials that generate valuable knowledge and lead to improved health outcomes for a wider range of children across the country.”

The DCOC will provide data coordination and biostatistics support, facilitate multi-site study design and results dissemination, help coordinate with local health systems, and train researchers and clinicians to increase their capacity to conduct pediatric research.

The NIH created the IDeA States Pediatric Clinical Trials Network in 2016 to provide access to clinical trials for rural or underserved children living in IDeA states. These states have historically low levels of research funding and limited access to vital clinical trials. The IDeA program was created to broaden the geographic distribution of NIH funding for biomedical and behavioral research.

There are 18 clinical research sites in the IDeA States Pediatric Clinical Trials Network. The grant will enable the DCOC to serve as the centralized unit that will support clinical trials across it.

Both KU Medical Center and UNMC have been part of the IDeA States Pediatric Clinical Trials Network since its inception.

“We have maintained a close working relationship through the first two cycles (of the ECHO program),” said Russell McCulloh, M.D., associate vice chancellor for clinical research at UNMC and a principal investigator. “The big strength that Nebraska provides is the experience of our Clinical Research Center and our experienced pediatric clinical trialists who have longstanding engagement in the network. These strengths are an excellent complement to KU’s outstanding expertise in biostatistics and informatics, and both sides have strong track records in conducting multi-site clinical trials.”

The clinical trials in the ECHO program focus on environmental influences that may affect child health, such as air pollution, family support, stress, sleep habits and diet. Recently published research has shown that adverse birth outcomes may be associated with arsenic in public drinking water, and that obesity, diabetes and high blood pressure before and after the mothers’ pregnancy are associated with higher blood pressure in children. These trials also provide access to health care teams for children that would not have had access otherwise.

“It’s exciting to put our foundation to work through a network that is expanding access to pediatric trials and building long-term research capacity in communities that have historically been underrepresented in clinical research,” said Jo Wick, Ph.D., professor of biostatistics and data science at KU Medical Center and a principal investigator. “Growing up in the Missouri Bootheel, I saw firsthand the challenges families in rural and under-resourced communities face in accessing high-quality health care. That experience gives me a deep appreciation for what the network stands for and for the significance of the responsibility we’ve been entrusted with as its Data Coordinating and Operations Center.”