UPENN HEAL - Pain Clinical Trial Network Specialized Clinical Center

项目摘要 提交这份多样性补充材料的目的是资助Danielle Kellier女士参与我们的 早期疼痛调查临床网络(EPPIC-)的专门临床中心 NET)，以了解疼痛疗法的临床试验的设计、实施和分析，并为 在健康的社会决定因素方面的专业知识和对增加研究多样性的热情 进程。Kellier女士目前在我们的流行病学博士项目中注册，这是她的MD/博士项目的一部分，网址为 宾夕法尼亚大学，并不是由任何其他NIH拨款资助的。 EPPIC-NET是美国国立卫生研究院帮助戒除成瘾长期伙伴关系的重要组成部分 旨在提供强大且可访问的基础设施，以便快速设计和实施高质量、 在明确的疼痛条件下，有前景的疼痛新疗法的全面第二阶段临床试验。 宾夕法尼亚大学医院(Hub)和另外6个宾夕法尼亚大学医疗系统中心(Spokes) 已被选为专业临床中心(SCC)之一，负责传导设计良好 将重点放在具有高度未满足治疗需求的疼痛患者(成人和儿童)的研究上。 宾夕法尼亚大学SCC希望使用包括适应性和平台在内的高效研究设计来测试新的疗法 生物标记物的研究、验证研究，以及生物标记物提供的原则或目标参与的证据 学术和行业合作伙伴产品的第二阶段试验研究。宾夕法尼亚大学的SCC将使临床 可通过公共访问数据获得的信息、神经成像、生物标记物、临床前数据和生物样本 与其他SCC合作，EPPIC-Net临床协调中心 (CCC)和数据协调中心(DCC)。宾夕法尼亚州立大学-SCC可以随时接触到广泛的患者 具有特定疼痛状况的人群，并在其特征方面拥有专业知识。宾夕法尼亚州立大学-SCC中心将 还为Hear-EPPIC Net计划提供科学领导和临床试验专业知识。 Hear-EPPIC网络的一个重要组成部分是在不同人群中测试新疗法 而且，正在做出重大努力，招募和招收代表人数不足的学科 组。Kellier女士对健康的社会决定因素有很大的兴趣和背景，并将 能够为EPPIC-Net的努力做出贡献，以增加招募来自种族或少数民族的患者 在临床研究中往往没有得到充分的代表。她还将设计并完成她的博士项目 确定表征儿童原发性头痛的卫生资源使用模式趋势的因素 和其他疼痛障碍使用电子健康记录数据，在她的导师约翰·T。 Farrar和Christina Szperka，目标是独立资助的研究生涯，以改善对 服务不足的人群。

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.