The Nebraska Pediatric Clinic Trials Unit

内布拉斯加州儿科临床试验单位

基本信息

批准号：
10242197
负责人：
Russell James McCulloh
金额：
$ 41.82万
依托单位：
UNIVERSITY OF NEBRASKA MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-23 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10242197
关键词：
Address Adherence Adoption Adult Adverse event Affect Age Awareness Capital Child Child Health Childhood Chronic Disease Clinic Clinical Research Clinical Trials Clinical Trials Design Clinical Trials Network Clinical Trials Unit Clinical trial protocol document Collaborations Communication Communities Conduct Clinical Trials Contracts Data Development Disease Educational Curriculum Effectiveness Enrollment Ensure Etiology Event Face Faculty Family Family health status Feedback First Independent Research Support and Transition Awards Funding Gender Goals Gold Great Plains Health Personnel Healthcare Hospitalized Child Human Individual Infrastructure Institution Institutional Review Boards Intervention Interview Knowledge Leadership Life Maintenance Measures Medical Medical center Mentorship Metabolism Multi-Institutional Clinical Trial Nebraska Nursing Faculty Outcome Outreach Research Patients Pediatric Hospitals Pediatric Research Performance Pharmaceutical Preparations Physicians Physiology Play Positioning Attribute Prevention Productivity Program Development Program Effectiveness Protocols documentation Reach, Effectiveness, Adoption, Implementation, and Maintenance Reporting Research Research Infrastructure Research Institute Research Personnel Resources Risk Role Rural Rural Community Safety Site Socioeconomic Status Time Training United States National Institutes of Health Universities Ursidae Family adverse event risk base career clinical trial enrollment community engagement community partnership drug efficacy drug metabolism effectiveness evaluation effectiveness measure faculty research feasibility trial high standard improved innovation medically underserved off-label drug off-label use outreach pediatric patients programs recruit research facility rural area rural dwellers rural families rural underserved side effect skills success underserved area underserved community

项目摘要

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 the RE-AIM framework. Renewing the NPCTU will: 1) enhance access to innovative medical therapies for Nebraska children; and 2) improve workforce capacity in Nebraska to conduct clinical trials, which will provide better health care options for pediatric patients.

项目概要/摘要临床试验是医疗干预有效性和安全性的最高证据标准。不幸的是，儿童经常接受从未在涉及临床试验中研究过的药物治疗由于儿童的差异，儿童对药物的反应通常与成人不同。生理学和药物代谢，使儿童面临不良甚至生命危险的风险增加此外，五分之一的美国儿童患有超适应症治疗的威胁事件。至少患有一种慢性病，并面临接受基于少量数据的治疗的风险。医疗服务不足的社区面临着无法从医疗中受益的巨大风险然而，研究人员往往无法让这些社区的个人参与研究。当被问及时，参加临床试验的儿童表示，他们的参与使他们能够获得更多治疗方案，提高了他们对疾病的了解，并为他们提供了机会自 2016 年起，IDeA 州儿科临床试验网络 (ISPCTN) 就开始参与其中。来自农村和医疗服务不足社区的儿童、家庭和医疗保健提供者获得高质量的服务内布拉斯加州儿科临床试验单位 (NPCTU) 在定义和制定儿科临床试验方面发挥着主导作用。确保 ISPCTN 内临床试验设计、启动和实施的最佳实践，并作为内布拉斯加州和邻近 IDeA 州儿科研究的变革性资源。目前的申请是进一步将临床试验参与机会和基础设施扩大到农村和 NPCTU 团队将通过扩大内布拉斯加州服务不足的社区来实现这一目标。具体来说，我们将加强农村地区的机构和社区伙伴关系。通过与内布拉斯加大学科尔尼分校的研究人员合作参与临床试验儿童医生科尔尼诊所的医疗保健提供者、儿童和家庭，以及通过定期与 Great Plains IDeA-CTR 合作，并与农村社区咨询委员会进行沟通。我们将培训儿科医疗保健提供者和研究人员参与其他 ISPCTN 地区站点 ISPCTN 批准的临床试验，并为初级教师提供指导和培训，使他们能够最后，作为儿童健康领域的核心资源，他们的职业生涯得到了发展。人大研究院将帮助提高整个国家研究基础设施的获取和利用率内布拉斯加大学医学中心和儿童医院及医疗中心 NPCTU 行政中心。团队将衡量和跟踪临床试验参与、实施和能力的关键绩效指标使用根据 RE-AIM 框架组织的指标进行建设将： 1) 增强。为内布拉斯加州儿童提供创新医疗疗法；2) 提高内布拉斯加州的劳动力能力进行临床试验，这将为儿科患者提供更好的医疗保健选择。