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（ISMMS）的伊坎医学院很强地参与任务早期疼痛调查临床网络（EPPIC-NET），ISMMS神经科作为轮毂和辐条结构的核心。我们的优势包括：（1）我们关心的大量和多样化的人口并在数十年中成功招募了临床试验，包括高影响疼痛的患者综合征，例如慢性腰痛（CLBP），（2）我们广泛的临床试验基础设施，包括关闭与ISMMS CTSA和试验创新网络（TIN）集成，该提案的PI领导与疼痛相关的活动，（3）多个专业中的高度经验丰富的临床试验者的干部 EPPIC-NET的研究范围内的专业知识将进行包括机械研究，详细的疼痛状况，生物标志物验证研究和2期临床试验的表型。我们非常致力于利用这些优势，我们经验丰富的领导团队为我们坚信的Eppic网络使命最终会产生非添加性疼痛治疗我们的病人非常需要。为了确保我们的站点和整个Eppic-Net结构是成功，我们的建议具有四个具体的目标：（1）简化和优化Eppic-的快速实施净研究，超过每年招募的100名受试者所需的100名受试者；（2）至使用集线器和发言模型以确保有效招募；（3）提供最高质量的协议实施，深疼痛障碍的临床表型，以及准确而完整的数据收集；（4）工作与Eppic-Net协调中心和调查人员合作，从NIH治疗伙伴关系到协助开发/设计临床试验并参与EPPIC-NET领导力。除这些目标外，我们还将促进机构中Eppic-Net的可见性和更大的痛苦研究社区，利用我们参与Eppic-NET作为培训初级调查人员的机会成为未来的疼痛临床试验领导者，并增加并传播有关疼痛研究的知识整个网络。