The Icahn School of Medicine at Mount Sinai (ISMMS) EPPIC-Net Specialized Clinical Center

摘要（来自父母） 西奈山伊坎医学院（ISMMS）处于有利地位，能够参与国际社会的使命。 早期疼痛研究临床网络（EPPIC-Net），与神经科的ISMMS部门作为 我们的中心和辐条结构的核心。我们的优势包括：（1）我们所照顾的庞大而多样化的人口 并在几十年内成功招募到临床试验中，包括患有高冲击性疼痛的患者， 综合征，如慢性腰痛（CLBP），（2）我们广泛的临床试验基础设施，包括密切 与ISMMS CTSA和试验创新网络（TIN）的整合，本提案的PI领导 疼痛相关活动，以及（3）在多个专业领域具有丰富经验的临床试验专家骨干 在EPPIC-Net将进行的一系列研究中，包括机制研究、疼痛的详细表型分析、 条件、生物标志物验证研究和2期临床试验。 我们坚定地致力于利用这些优势和我们经验丰富的领导团队为EPPIC服务- Net的使命，我们坚信这将最终产生非成瘾性的疼痛治疗， 患者迫切需要的。为了确保我们的网站和整个EPPIC网络结构的成功， 我们的建议有四个具体目标：（1）简化和优化EPPIC网络研究的快速实施， 超过EPPIC-Net研究每年招募100名受试者的最低要求;（2）确保访问 对患有各种疼痛疾病（包括CLBP）的患者人群，使用中心和辐条模型， 确保有效招募;（3）提供最高质量的方案执行，深入临床表型分析 疼痛障碍的研究，以及准确和完整的数据收集;（4）与EPPIC-Net合作 NIH HEAL合作伙伴的协调中心和研究人员协助开发/设计 临床试验和从事EPPIC网络的领导。 除了这些目标之外，我们还将在我们的机构内推广EPPIC-Net的知名度， 研究社区，利用我们参与EPPIC网络作为培训初级研究人员的机会， 成为未来疼痛临床试验的领导者，并增加和传播有关疼痛研究的知识 在我们的网络中。

ABSTRACT (from the parent) The Icahn School of Medicine at Mount Sinai (ISMMS) is strongly-positioned to engage in the mission of the Early Phase Pain Investigation Clinical Network (EPPIC-Net), with the ISMMS Department of Neurology as the core of our hub and spokes structure. Our strengths include: (1) the large and diverse population we care for and have successfully recruited into clinical trials over several decades including patients with high impact pain syndromes such as chronic low back pain (CLBP), (2) our extensive clinical trials infrastructure, including close integration with the ISMMS CTSA and Trials Innovation Network (TIN), for which the PI of this proposal leads pain-related activities, and (3) a cadre of highly-experienced clinical trialists in multiple specialties with expertise across the range of studies EPPIC-Net will perform including mechanistic studies, detailed phenotyping of pain conditions, biomarker validation studies, and phase 2 clinical trials. We are deeply committed to using these strengths and our experienced leadership team in service of the EPPIC- Net mission which we strongly believe will ultimately produce the non-addictive pain treatments which our patients so desperately need. In order to ensure that our site and the entire EPPIC-Net structure is a success, our proposal has four specific aims: (1) to streamline and optimize rapid implementation of EPPIC-Net studies, exceeding the required minimum of 100 subjects recruited per year to EPPIC-Net studies; (2) to ensure access to patient populations with a wide range of pain disorders, including CLBP, using a hub and spokes model to ensure effective recruitment; (3) to provide the highest-quality protocol implementation, deep clinical phenotyping of pain disorders, and accurate and complete data collection; and (4) to work collaboratively with the EPPIC-Net Coordinating Centers and investigators from the NIH HEAL Partnership to assist with development/design of clinical trials and engage in EPPIC-Net leadership. In addition to these aims we will promote the visibility of EPPIC-Net within our institution and the larger pain research community, use our participation in EPPIC-Net as an opportunity to train junior investigators to become future pain clinical trials leaders and increase and disseminate knowledge about pain research throughout our network.