Sept. 21, 2016 | The University of Arkansas for Medical Sciences (UAMS) has been awarded $41.8 million from the National Institutes of Health (NIH) to oversee a 17-site pediatric clinical trial network that will provide medically underserved and rural children access to clinical studies studying environmental influences on early development.
UAMS will be the Data Coordinating and Operations Center (DCOC) for the IDeA States Pediatric Clinical Trial Network (ISPCTN), and was awarded this after competing among several other institutions.
UAMS’ award is part of a national seven-year, $157 million initiative announced today by the NIH called Environmental influences on Child Health Outcomes (ECHO). The ECHO initiative will investigate how exposure to a range of environmental factors in early development — conception through early childhood — affects the health of children and adolescents.
The UAMS DCOC will be the central unit within the ISPCTN that provides data coordination, technical instruction, data standards, quality control and assurance and operational coordination for the clinical trials.
Principal investigators are Charlotte Hobbs, M.D., Ph.D., executive associate dean for research in the UAMS College of Medicine and the Pamela D. Stephens professor of Birth Defects Research; and Jeannette Lee, Ph.D., professor of biostatistics in the UAMS College of Medicine.
Both investigators bring much experience in their respective fields. Hobbs, a pediatrician and epidemiologist, has been involved with research initiatives supported through the Children’s Health Act since 2001. Lee has been the director of Data Coordinating and Operations Centers in other clinical trials.
“The ECHO program is vital for improving the health of children in rural and medically underserved areas of Arkansas and across the nation,” said Pope L. Moseley, M.D., the executive vice chancellor of UAMS and dean of the College of Medicine.
“The UAMS College of Medicine has extensive experience in the management of the ‘big data’ that drives transformational research, as well as in leadership and administration of major clinical trials in rural areas,” Moseley said. “We look forward to working with our faculty colleagues at the Arkansas Children’s Research Institute and the 16 other clinical sites in the IDeA States Pediatric Clinical Trials Network that we will support and lead as the Data Coordinating and Operations Center.”
Arkansas Children’s Research Institute (ACRI) will receive $1.9 million from the NIH to fund one of the 17 clinical sites, to be led by Laura James, M.D., UAMS associate vice chancellor for clinical and translational research and director of UAMS’ Translational Research Institute; and ACRI President Gregory L. Kearns, Pharm.D., Ph.D.
UAMS Chancellor Dan Rahn, M.D., said UAMS’ role overseeing the clinical network is essential.
“This research will help us gain a better understanding of how genetic and environmental influences in early childhood development interact to impact overall child and adult health. Dr. Hobbs has extensive experience with genetic and environmental influences in early childhood development and Dr. Lee has expertise with analysis of complex data. Both are recognized nationally and internationally for their leadership in this field.”
The overall NIH award will build the infrastructure and capacity for the ECHO program to support multiple, longitudinal studies that extend and expand existing studies of mothers and their children.
“Providing health care to infants and children living in rural and medically underserved areas may present different challenges and opportunities compared to those living in urban areas,” Hobbs said. “As a pediatrician and epidemiologist, I am delighted to be able to have a leadership role in this exciting new opportunity to improve the health of infants and children.”
Lee said, “We are delighted to have the opportunity to lead the DCOC in this unique program to increase access to clinical trials to children in rural and medically underserved areas. Historically, these children have been underrepresented in clinical trials and their participation is essential to efforts to improve their health outcomes.”
The NIH announcement can be found at www.nih.gov/news-events/news-releases/nih-awards-157-million-research-early-environmental-influences-children.
Experiences during sensitive developmental windows, including around the time of conception, later in pregnancy, and during infancy and early childhood, can have long-lasting effects on the health of children.
These experiences encompass a broad range of exposures, from air pollution and chemicals in our neighborhoods, to factors such as stress, sleep and diet. These factors may influence any number of biological processes, for example changes in the expression of genes or development of the immune system.
Research reported in this press release was supported by the National Institute of General Medical Sciences of the National Institutes of Health under award number 1U24HD090912-01.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.