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：
10208322
负责人：
Jessica Robinson-Papp
金额：
$ 10万
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：
2020
资助国家：
美国
起止时间：
2020-09-30 至 2022-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10208322
关键词：
African American Agreement Anesthesiology Caring Chronic low back pain Clinical Clinical Trials Clinical Trials Design Collaborations Communities Connecticut Data Collection Development Discipline of Nursing Discipline of obstetrics Emergency Medicine Ensure Faculty Future Gastroenterology Geriatrics Gynecology Health Personnel Health Sciences Health system Hematology Hispanics Hospitals Infrastructure Institution Institutional Review Boards Internal Medicine Knowledge Leadership Medicine Minority Mission Modeling National Institute of Neurological Disorders and Stroke Neurology New York City Oncology Ophthalmology Orthopedics Pain Pain Disorder Pain Research Pain management Palliative Care Participant Patients Pediatrics Phase Phase II Clinical Trials Phenotype Physical Medicine Physical Rehabilitation Placebo Effect Podiatry Population Population Heterogeneity Positioning Attribute Protocols documentation Psychiatry Psychology Reporting Research Research Personnel Rheumatology Services Site Structure Syndrome Tennessee Testing Training Underinsured United States Department of Veterans Affairs United States National Institutes of Health Universities Work addiction biomarker validation clinical center clinical investigation clinical pain clinical phenotype clinical practice data quality design effective therapy experience flexibility improved innovation medical schools medical specialties member multidisciplinary neurosurgery operation patient population protocol violation recruit success validation studies

项目摘要

ABSTRACT 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.

抽象的西奈山伊坎医学院 (ISMMS) 处于有利地位，可以参与到以下使命中：早期疼痛调查临床网络 (EPPIC-Net)，以 ISMMS 神经内科为中心我们的轮辐结构的核心。我们的优势包括：(1) 我们所关心的人口数量庞大且多样化并已成功招募患者参加数十年的临床试验，其中包括患有高冲击性疼痛的患者慢性腰痛 (CLBP) 等综合症，(2) 我们广泛的临床试验基础设施，包括密切关注与 ISMMS CTSA 和试验创新网络 (TIN) 的集成，本提案的 PI 对此负责与疼痛相关的活动，以及 (3) 一支由多个专业领域经验丰富的临床试验人员组成的骨干队伍 EPPIC-Net 将进行的一系列研究的专业知识，包括机制研究、详细疼痛状况的表型分析、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我们坚信 EPPIC-Net 的使命最终将产生非成瘾性疼痛治疗方法，我们的患者非常需要。为了确保我们的网站和整个 EPPIC-Net 结构是一个成功后，我们的提案有四个具体目标：(1) 简化和优化 EPPIC 的快速实施网络研究，超过每年招募 100 名受试者参加 EPPIC-Net 研究的最低要求； (2) 至确保使用中心和服务接触到患有各种疼痛疾病（包括 CLBP）的患者群体辐条模型，确保有效招聘；（3）提供最高质量的协议实现，深度疼痛疾病的临床表型分析，以及准确完整的数据收集； (4) 工作与 EPPIC-Net 协调中心和 NIH HEAL Partnership 的研究人员合作，协助临床试验的开发/设计并参与 EPPIC-Net 的领导。除了这些目标之外，我们还将提高 EPPIC-Net 在我们机构内的知名度，并解决更大的问题研究社区，利用我们参与 EPPIC-Net 的机会来培训初级研究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整个网络中。