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

项目摘要 早期疼痛研究临床网络（EPPIC-Net）和EPPIC- Net倡议是快速有效地将疼痛神经生物学的进展转化为 治疗慢性和急性疼痛的人，与显着相关的条件 给患者和社会带来负担。成功和高效率地发展 疼痛患者的新疗法包括监管和制度方面的效率低下， 提交和批准，招募受试者的各种障碍， 临床研究，试验质量保证不足，缺乏训练有素的人员 并准备参与和领导多中心试验。临床的主要目标 EPPIC网络协调中心（CCC）从最初的概念开始， 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的临床试验 提供有效的方法、组织和后勤支持。EPPIC-网络-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， 保留以及增加临床研究者和研究人员的数量 受过培训，对领导和开展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合作临床协调中心 多学科临床研究和数据管理专业知识， 设计和开展多中心II期临床试验所需的领导力和基础设施， 生物标志物验证研究和患者人群的深度表型分析，以了解 特定疼痛状况的生物学基础及其对治疗的反应。具体目标2 我们的建议是扩大有经验的临床研究者和研究人员的库， 通过提供教育，培训， 资源和专业指导。最后，我们建议的具体目标3是 通过与EPPIC网络合作，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 研究者将进行多中心II期临床试验、生物标志物验证研究和深入研究。 对患者人群进行表型分析，以了解特定疼痛状况的生物学基础 及其对治疗的反应。

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.