# The Nebraska Pediatric Clinic Trials Unit

> **NIH NIH UG1** · UNIVERSITY OF NEBRASKA MEDICAL CENTER · 2024 · $400,241

## Abstract

Project Summary/Abstract
Clinical trials are the highest standard of evidence for the effectiveness and safety of medical interventions.
Unfortunately, children often receive medical therapies that have never been studied in clinical trials involving
pediatric subjects. Children often respond differently from adults to medications due to differences in
physiology and drug metabolism, placing children at increased risk of experiencing adverse, even life-
threatening events from off-label use of medical treatments. Additionally, one-fifth of US children suffer from at
least one chronic disease and face the risks of receiving treatments based on scant data. Children from rural
and medically underserved communities bear a disproportionately large risk of not benefiting from medical
treatments as researchers often fail to engage individuals from these communities in research. However, when
asked, children enrolled in clinical trials state that their participation provided them with access to more
treatment options, improved their understanding of their disease, and provided them with the opportunity to
help other people. Since 2016 the IDeA States Pediatric Clinical Trials Network (ISPCTN) has engaged
children, families, and health care providers from rural and medically underserved communities in high-quality
pediatric clinical trials. The Nebraska Pediatric Clinical Trials Unit (NPCTU) plays a leading role in defining and
ensuring best practices in clinical trials design, initiation, and conduct within the ISPCTN and serves as a
transformative resource for pediatric research in Nebraska and neighboring IDeA states. The objective of the
current application is to further extend clinical trials participation opportunities and infrastructure to rural and
underserved communities across Nebraska. The NPCTU team will achieve this objective by expanding
institutional and community partnerships regionally and nationally. Specifically, we will increase rural
engagement in clinical trials through partnership with researchers at the University of Nebraska at Kearney and
health care providers, children, and families at the Children’s Physicians Kearney clinic, and through regular
communication with a rural community advisory board. In partnership with the Great Plains IDeA-CTR and
other ISPCTN sites regionally we will train pediatric health care providers and research staff to participate in
ISPCTN-approved clinical trials and provide junior faculty with mentorship and training that enables them to
advance their careers as researchers in child health. Finally, as a core resource within the Child Health
Research Institute, the NPCTU will help increase research infrastructure access and utilization across the
University of Nebraska Medical Center and Children’s Hospital & Medical Center. The NPCTU administrative
team will measure and track key performance indicators of clinical trials engagement, conduct, and capacity-
building using metrics organized according to...

## Key facts

- **NIH application ID:** 10910925
- **Project number:** 5UG1OD024953-07
- **Recipient organization:** UNIVERSITY OF NEBRASKA MEDICAL CENTER
- **Principal Investigator:** Ellen Kerns
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $400,241
- **Award type:** 5
- **Project period:** 2016-09-23 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10910925

## Citation

> US National Institutes of Health, RePORTER application 10910925, The Nebraska Pediatric Clinic Trials Unit (5UG1OD024953-07). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10910925. Licensed CC0.

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