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

• 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
• 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

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.

摘要 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)一批经验丰富的多个专科的临床试验人员， EPPIC-Net将执行的研究范围内的专业知识，包括详细的机械研究 疼痛状况的表型鉴定、生物标记物验证研究和2期临床试验。 我们致力于利用这些优势和我们经验丰富的领导团队为 EPPIC-Net使命，我们坚信最终将产生不会上瘾的疼痛治疗 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，我们的建议有四个具体目标：(1)精简和优化EPPIC的快速实施- 净研究，超过要求每年至少招募100名受试者参加EPPIC-NET研究；(2)至 确保能够接触到患有各种疼痛障碍的患者群体，包括CLBP，并使用 辐条模式，确保有效招聘；(3)提供最优质的协议执行，深度 疼痛障碍的临床表型，以及准确和完整的数据收集；以及(4)工作 与EPPIC-Net协调中心和NIH Hear合作伙伴关系的调查人员合作 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。