UPENN HEAL - Pain Clinical Trial Network Specialized Clinical Center

项目摘要 本次拨款提交的目的是宾夕法尼亚大学卫生系统患者的建议 护理结构作为早期疼痛研究临床的专业临床中心（SCC -“枢纽”） 网络（EPPIC-Net）。EPPIC网络将作为美国国立卫生研究院帮助结束成瘾长期的基石， 长期（治愈）伙伴关系。EPPIC网络将提供一个强大的和随时可用的基础设施， 对明确定义的疼痛患者进行高质量、全面的研究 条件，以及快速设计和执行高质量的2期临床试验，以测试有前途的新的 疼痛治疗使用宾夕法尼亚大学医院作为中心和5个额外的中心 这是宾夕法尼亚大学卫生系统和费城儿童医院（CHOP）的一部分， 研究将按照EPPIC网络的专业知识设计进行，该网络旨在带来密集的 重点关注相对较少的临床明确定义的疼痛状况和高未满足的患者 治疗需求。研究可在成人或儿童人群中进行。宾夕法尼亚大学SCC预计， 测试新的，有效的研究设计，包括自适应和平台设计， 生物标志物和生物标志物知情的原理证明或靶点参与研究， 学术界和行业合作伙伴的参与。宾夕法尼亚大学的网站将协助EPPIC网络进行临床， 神经成像、生物标志物和临床前数据以及生物样本，可通过公共访问数据获得 和生物标本库。预计EPPIC网络将能够运行多达五个临床试验 同时，除了深入的临床表型和生物标志物验证研究。SCC将是 预计将与其他SCC以及EPPIC网络临床协调中心合作 (CCC)数据协调中心（DCC）。UPenn-SCC已经准备好接触患者人群， 特定的疼痛状况，包括腰痛，并在其表征方面具有专业知识。此外，本发明还 宾夕法尼亚大学- SCC HUB将为其6个卫星站点提供科学领导和行政监督 （“轮辐”）。目前的建议是建立宾夕法尼亚大学SCC中心和辐条， 确定潜在人群，但不包括任何临床试验的资金。 这将在稍后与EPPIC网络和NIH的单独合同中进行谈判。

Project Summary The purpose of this grant submission is the proposal of the University of Pennsylvania Health System patient care structure as a Specialized Clinical Centers (SCC - "hubs") of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIH's Helping to End Addiction Long- term (HEAL) Partnership. EPPIC-Net will provide a robust and readily accessible infrastructure for the rapid implementation and performance of high-quality, comprehensive studies of patients with well-defined pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain. Using the Hospital of the University of Pennsylvania as a HUB and 5 additional centers that are part of the UPenn Health system and the Children's Hosptial of Philadelphia (CHOP) as Spokes, studies will be conducted as designed by the expertise of the EPPIC network, which intends to bring intense focus to relatively small numbers of patients with clinically well-defined pain conditions and high unmet therapeutic needs. Studies may be performed in either adult or pediatric populations. The UPenn SCC expects to be testing novel, efficient study designs including adaptive and platform designs, validation studies of biomarkers, and biomarker-informed proof of principle or target engagement studies in Phase 2 trials of interventions from academic and industry partners. The UPenn site will assist the EPPIC-Net to make clinical, neuroimaging, biomarker, and preclinical data, as well as biosamples, available through public access data and biospecimen repositories. It is anticipated that EPPIC-Net will be able to run up to five clinical trials concurrently, in addition to deep clinical phenotyping and biomarker validation studies. The SCC will be expected to work collaboratively with the other SCC as well as the EPPIC-Net Clinical Coordinating Center (CCC) and Data Coordinating Center (DCC). The UPenn-SCC has ready access to patient populations with specific pain conditions, including low back pain, and have expertise in their characterization. Additionally, UPenn- SCC HUB will provide scientific leadership and administrative oversight to its 6 satellite sites (“Spokes”). The current proposal is for the establishment of the UPenn-SCC HUB and Spokes, and identification of potential populations but will not include funding for any of the clinical trials to be conducted. This will be negotiated later in a separate contract with the EPPIC Network and NIH.