Our Partners at the Nebraska Pediatric Clinical Trials Unit
It is well known that clinical research plays a crucial role in advancing the diagnosis, treatment, and prevention of disease. Unfortunately, children are often underrepresented in clinical research, which significantly impacts our ability to provide evidence-based medical care for kids (2). In addition, there is often a mismatch between the locations where clinical research occurs and where disease is most prevalent. Racial and ethnic minorities, rural populations and patients of low socioeconomic status continue to be underrepresented in clinical trials and even more so among pediatric studies (1,3,4). Expanding our ability to perform high-quality, multi-center pediatric clinical trials that include underserved populations is essential to increase our understanding of child health, improve the generalizability of clinical trials data, as well as provide children with greater access to cutting-edge medical care (1).
Building on the Institutional Development Award (IDeA) program infrastructure, the National Institutes of Health (NIH) developed the IDeA States Pediatric Network (ISPN) in order to begin to address these gaps in pediatric clinical research. As a part of the NIH-funded Environmental influences on Child Health Outcomes (ECHO) project, the ISPN engages institutions from 17 states across the country who have historically received low levels of federal funding. The overall mission of the ISPN is to improve the reach of pediatric clinical trials to rural and underserved populations, and to enhance clinical trials capacity at the institutions who serve these populations. In order to accomplish this, the ISPN is currently developing pediatric clinical trials that aim to address ECHO’s five main priority areas, including upper and lower airway disease, obesity, pre-, peri-, and postnatal outcomes, neurodevelopment, and overall positive child health. Current and upcoming trials include ACT NOW, which aims to improve care of infants with Neonatal Opioid Withdrawal Syndrome, and VDORA, which will investigate the use of vitamin D supplementation in obese children with asthma.
As Nebraska’s representative in the ISPN, the Nebraska Pediatric Clinical Trials Unit (NPCTU) is backed by considerable institutional commitment and support from both the University of Nebraska Medical Center and Children’s Hospital & Medical Center. Led by Dr. Russell McCulloh, our team is actively working to engage junior investigators in ISPN-sponsored clinical trials, and to improve the overall quality of research by providing infrastructure and personnel support at all levels. In collaboration with UNMC’s Child Health Research Institute and the Pediatric Research Office, the NPCTU is looking forward to a future where all of Nebraska’s children have access to innovative research opportunities, and where more rural providers are engaged in clinical trials. We are always looking to expand our network of collaborators, so if you are interested in learning more about potential research opportunities, please feel free to reach out to our team at npctu@unmc.edu or visit our website.
References:
1. Bolen S, Tilburt J, BaffiC, et al. Defining “success” in recruitment of underrepresented populations to cancer clinical trials: Moving toward a more consistent approach. Cancer. 2006;106(6):1197-1204.
2. Bourgeois FT, Murthy S, Pinto C, Olson KL, Ioannidis JP, Mandl KD. Pediatric versus adult drug trials for conditions with high pediatric disease burden. Pediatrics. 2012;130(2):285-292.
3. Ford JG, Howerton MW, Lai GY, et al. Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review. Cancer. 2008;112(2):228-242.
4. Burchard EG, Oh SS,Foreman MG, Celedon JC. Moving toward true inclusion of racial/ethnic minorities in federally funded studies: a key step for achieving respiratory health equality in the United States. Am J Respir Crit Care Med. 2015;191(5):514-521.
