Clinical Coordinating Center for the Health Initiative in Early Phase Pain Investigation Clinical Network

项目摘要 早期疼痛调查临床网络(EPPIC-NET)和EPPIC-Net的目标 Net的倡议是快速有效地将疼痛神经生物学的进展转化为 对慢性和急性疼痛患者的治疗，与显著的 给患者和社会都带来了负担。成功和高效发展面临的挑战 对疼痛患者的新治疗包括监管和制度上的低效 提交和批准，各种阻碍招募科目的障碍 临床研究，试验质量保证不充分，以及缺乏培训的个人 并准备参与和领导多中心试验。临床研究的首要目标 EPPIC-Net的协调中心(CCC)从最初的概念就是促进和促进 通过最终分析，在患有急性或慢性疼痛的成人和儿童人群中进行临床试验 通过提供有效的方法、组织和后勤支助。EPPIC-NET-CCC 将采用和建立旨在大幅提高多中心效率的流程 临床试验，提高临床试验的整体质量，促进患者招募和 留住以及增加临床研究人员和研究人员的数量 受过培训，对领导和进行多中心临床试验充满热情。具体目标 我们的建议之一是通过一个协作的临床协调中心来利用 多学科临床研究和数据管理专业知识提供科学的 设计和实施多站点第二阶段临床试验所需的领导力和基础设施， 生物标志物验证研究，以及对患者群体的深入表型分析，以了解 特定疼痛状况的生物学基础及其对治疗的反应。的具体目标2 我们的建议是扩大有经验的临床研究人员和研究人员的队伍 多中心临床研究试验的参与者和领导者通过提供教育、培训、 资源和专业指导。最后，我们提案的具体目标3是参与 通过与EPPIC-Net合作，动员联邦、行业、基金会和患者合作伙伴 指导委员会(EPPIC-Net-SC)、EPPIC-Net-DCC和项目组负责人 研究人员将进行多地点第二阶段临床试验、生物标记物验证研究和深度 对患者群体进行表型分型以了解特定疼痛状况的生物学基础 以及它对治疗的反应。

Project Summary The objective of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) and EPPIC- Net initiatives is to rapidly and efficiently translate advances in the neurobiology of pain into treatments for people with chronic and acute pain, conditions associated with a significant burden to both patients and society. Challenges to the successful and efficient development of novel treatments for people with pain include inefficiencies in regulatory and institutional submissions and approvals, a variety of barriers to recruitment of subjects that slow down clinical research, inadequate quality assurance of trials, and a shortage of individuals trained and prepared to participate in and lead multicenter trials. The primary goal of the Clinical Coordinating Center (CCC) for EPPIC-Net is to promote and facilitate, from initial conception through final analysis, clinical trials in adult and pediatric populations with acute or chronic pain by providing efficient methodological, organizational and logistical support. The EPPIC-Net-CCC will adopt and establish processes aimed at dramatically increasing the efficiency of multicenter clinical trials, improving the overall quality of clinical trials, promoting patient recruitment and retention as well as increasing the number of clinical investigators and research staff well trained and passionate about leading and conducting multicenter clinical trials. The Specific Aim 1 of our proposal is to harness through a collaborative Clinical Coordinating Center multidisciplinary clinical research and data management expertise to provide the scientific leadership and infrastructure required to design and conduct multi-site Phase 2 clinical trials, biomarker validation studies, and deep phenotyping of patient populations to understand the biologic basis of a specific pain condition and its response to treatment. The Specific Aim 2 of our proposal is to expand the pool of experienced clinical Investigators and research staff to be participants and leaders of multicenter clinical research trials by providing education, training, resources and professional mentorship. Finally, the Specific Aim 3 of our proposal is to engage and mobilize federal, industry, foundations and patient partners by working with the EPPIC-Net Steering Committee (EPPIC-Net-SC), EPPIC-Net-DCC and Project Team Principal Investigators to conduct multi-site Phase 2 clinical trials, biomarker validation studies, and deep phenotyping of patient populations to understand the biologic basis of a specific pain condition and its response to treatment.