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

西奈山伊坎医学院 (ISMMS) EPPIC-Net 专业临床中心

基本信息

批准号：
10888777
负责人：
Jessica Robinson-Papp
金额：
$ 20.13万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-30 至 2024-08-31
项目状态：
已结题

项目摘要

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.

摘要(来自父级) 位于西奈山的伊坎医学院(ISMMS)处于有利地位，可以参与到早期疼痛调查临床网络(EPPIC-NET)，ISMMS神经内科为我们的轮毂和辐条结构的核心。我们的优势包括：(1)我们关心的人口众多和多样化并在几十年内成功地纳入临床试验，包括患有高度冲击性疼痛的患者症状，如慢性下腰痛(CLBP)，(2)我们广泛的临床试验基础设施，包括与ISMMS CTSA和试验创新网络(TIN)的整合，本提案的PI领导该网络与疼痛相关的活动，以及(3)具有专业知识的多个专科的经验丰富的临床试验人员队伍 EPPIC-Net将进行的研究范围包括机械学研究、疼痛的详细表型分析条件、生物标记物验证研究和第二阶段临床试验。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使命，我们坚信最终将产生非成瘾性疼痛治疗，我们的病人是如此迫切需要。为了确保我们的网站和整个EPPIC-Net结构的成功，我们的建议有四个具体目标：(1)精简和优化EPPIC-Net研究的快速实施，超过要求的每年至少招募100名受试者参加EPPIC-Net研究；(2)确保获得对于患有各种疼痛障碍的患者群体，包括CLBP，使用中枢和辐条模型来确保有效招募；(3)提供最高质量的方案执行，深度临床表型以及(4)与EPPIC网络合作来自NIH Hear合作伙伴的协调中心和调查人员协助开发/设计临床试验和参与EPPIC-Net领导。除了这些目标外，我们还将促进EPPIC-Net在我们机构内的可见度和更大的痛苦研究界，利用我们参与EPPIC-Net的机会培训初级调查人员成为未来疼痛临床试验的领导者，增加和传播有关疼痛研究的知识在我们的网络中。