UPENN HEAL - Pain Clinical Trial Network Specialized Clinical Center

UPENN HEAL - 疼痛临床试验网络专业临床中心

• 批准号: 10405954
• 负责人: Michael Alan Ashburn
• 金额: $ 16.63万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10405954
• 关键词: Adult; Biological Markers; Biological Specimen Banks; Caring; Charge; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Contracts; Data; Data Coordinating Center; Doctor of Philosophy; Electronic Health Record; Enrollment; Epidemiology; Funding; Grant; Headache; Health Resources; Health system; Helping to End Addiction Long-term; Infrastructure; Leadership; Learning; Mentors; Pain; Pain Disorder; Pain management; Patient Recruitments; Pattern; Pennsylvania; Phase; Phase II Clinical Trials; Population Heterogeneity; Process; Research; Research Design; Sampling; Specialized Center; Syndrome; Testing; Therapeutic; Therapeutic Uses; Underrepresented Populations; Underserved Population; United States National Institutes of Health; Universities; University Hospitals; career; chronic pain; chronic pain patient; clinical center; clinical investigation; clinical pain; clinical trial analysis; data access; data repository; design; ethnic minority population; improved; industry partner; interest; neuroimaging marker; novel therapeutics; pain patient; patient population; phase II trial; potential biomarker; pre-clinical; programs; racial minority; recruit; social health determinants; trend; validation studies

Project Summary The purpose of this diversity supplement submission is to fund Ms. Danielle Kellier's participation in our Specialized Clinical Centers (SCC - "Hubs") of the Early Phase Pain Investigation Clinical Network (EPPIC- Net) to learn about the design, conduct, and analysis of clinical trials for pain therapies and to contribute her expertise in the social determinants of health and passion for increasing diversity in research to the overall process. Ms. Kellier is currently enrolled in our Epidemiology PhD program as part of her MD/PhD program at the University of Pennsylvania and is not funded by any other NIH grant. EPPIC-Net is an important component of the NIH's Helping to End Addiction Long-term (HEAL) Partnership designed to provide a robust and accessible infrastructure for the rapid design and conduct of high-quality, comprehensive Phase 2 clinical trials of promising novel therapeutics for pain in well-defined pain conditions. The Hospital of the University of Pennsylvania (Hub) and 6 additional Penn Health system centers (Spokes) has been selected as one of the Specialized Clinical Centers (SCC) charged with conduction well designed studies to bring intense focus to pain patients (both adult and pediatric) with high unmet therapeutic needs. The Penn SCC expects to test novel therapeutics using efficient study designs including adaptive and platform studies, validation studies of biomarkers, and biomarker-informed proof of principle or target engagement studies in phase 2 trials of products from academic and industry partners. The Penn SCC will make clinical information, neuroimaging, biomarker, preclinical data, and bio-samples available through public access data and biospecimen repositories in collaboration with the other SCCs, the EPPIC-Net Clinical Coordinating Center (CCC), and Data Coordinating Center (DCC). The Penn-SCC has ready access to a broad range of patient populations with specific pain conditions and has expertise in their characterization. The Penn-SCC Hub will also provide scientific leadership and clinical trial expertise to the HEAL-EPPIC net program. An important component of the HEAL-EPPIC Net is the testing of novel therapeutics in a diverse population and significant effort is being put into the recruitment and enrollment of subjects from under-represented groups. Ms. Kellier has a substantial interest and background in the social determinants of health and will be able contribute to the EPPIC-Net's efforts to increase the recruitment of patients from racial or ethnic minorities that are often underrepresented within clinical research. She will also design and complete her doctoral project identifying factors that characterize trends in health resource use patterns for children with primary headache and other pain disorders use electronic health record data, under the guidance of her mentors, Drs. John T. Farrar and Christina Szperka, with a target of an independently funded research career to improve care for underserved populations.

项目摘要 本次多样性补充提交的目的是资助Danielle Kellier女士参与我们的 早期疼痛研究临床网络（EPPIC-）的专业临床中心（SCC -“中心”） Net）学习疼痛治疗临床试验的设计、实施和分析， 在健康的社会决定因素的专业知识和增加研究的整体多样性的热情 过程Kellier女士目前就读于我们的流行病学博士课程，作为她的MD/博士课程的一部分， 宾夕法尼亚大学，不受任何其他NIH资助。 EPPIC网络是美国国立卫生研究院帮助结束成瘾长期（HEAL）伙伴关系的重要组成部分 旨在提供一个强大的和可访问的基础设施，用于快速设计和进行高质量， 在明确定义的疼痛条件下进行的有希望的新型疼痛治疗方法的全面2期临床试验。 宾夕法尼亚大学医院（Hub）和6个额外的宾夕法尼亚健康系统中心（Spokes） 已被选为专业临床中心（SCC）之一，负责精心设计的传导 研究重点关注疼痛患者（成人和儿童），这些患者的治疗需求高度未得到满足。 Penn SCC希望使用有效的研究设计来测试新的治疗方法，包括自适应和平台 生物标志物的研究、验证研究和生物标志物知情的原理或靶点参与证明 来自学术和行业合作伙伴的产品的2期试验研究。宾夕法尼亚州SCC将使临床 信息、神经成像、生物标志物、临床前数据和通过公共访问数据可获得的生物样本 与其他SCC、EPPIC网络临床协调中心合作， (CCC)数据协调中心（DCC）。宾夕法尼亚州SCC已经准备好接触广泛的患者 具有特定疼痛状况的人群，并在其表征方面具有专业知识。Penn-SCC中心将 还为HEAL-EPPIC网络计划提供科学领导和临床试验专业知识。 HEAL-EPPIC网络的一个重要组成部分是在不同人群中测试新疗法 正在大力招募和招收代表性不足的受试者， 组Kellier女士对健康的社会决定因素有着浓厚的兴趣和背景， 能够为EPPIC网络增加招募少数种族或族裔患者的努力做出贡献 在临床研究中往往代表性不足。她还将设计并完成她的博士项目 确定原发性头痛儿童卫生资源使用模式趋势的特征因素 和其他疼痛疾病使用电子健康记录数据，在她的导师，约翰T。 Farrar和Christina Szperka的目标是独立资助的研究事业，以改善对 服务不足的人群。