University of Rochester Hub and Spokes for the EPPIC Network - Specialized Clinical Center

罗彻斯特大学 EPPIC 网络的中心和发言人 - 专业临床中心

• 批准号: 10413418
• 负责人: Jennifer Gewandter
• 金额: $ 15.11万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-01 至 2023-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10413418
• 关键词: Accelerometer; Address; Administrative Supplement; Adult; Affect; Analgesics; Chronic low back pain; Clinical Research; Clinical Trials; Clinical Trials Network; Data; Development; Family member; Friends; Funding; Goals; Individual; Infrastructure; Intermittent Claudication; Mentors; Methods; Opioid Analgesics; Outcome; Outcome Measure; Pain; Pain Research; Pain management; Pain quality; Performance; Phase; Phase II Clinical Trials; Phenotype; Publications; Randomized Clinical Trials; Research; Research Activity; Research Personnel; Research Project Grants; Risk; Syndrome; Testing; Training; United States National Institutes of Health; Universities; addiction; base; chronic pain; clinical center; clinical investigation; clinical pain; clinically relevant; design; educational atmosphere; effective therapy; experience; improved; novel; novel marker; novel therapeutics; opioid epidemic; programs; side effect; skills

PROJECT SUMMARY / ABSTRACT Chronic pain impacts 20-30% of U.S. adults. Unfortunately, currently available pain treatments tend to be only moderately effective and there are many individuals for whom treatments do not provide any relief or who cannot tolerate their adverse side effects. Attempts to treat chronic pain with opioid analgesics contributed, at least in part, to the current opioid crisis, affecting both individuals with pain and their family members and friends, highlighting the need for the development of novel, non-addictive analgesics. The NIH responded to this need by emphasizing the importance of high-quality analgesic clinical trials that incorporate novel biomarkers and endpoints in order to promote the development of effective analgesics. To drive this effort, the NIH established the Early Phase Pain Investigation Clinical Network (EPPIC-Net) to provide a robust and readily accessible infrastructure for rapid design and performance of phase II clinical trials. The PI of this application is the MPI of the University of Rochester EPPIC-Net, specialized clinical research center (UR-EPPIC-Net), providing a unique opportunity to train mentees in the conduct of multisite analgesic clinical trials. Further, the PI’s ongoing program of research addresses the need for novel outcome measures in analgesic clinical trials and synergizes with EPPIC-Net efforts to (1) make valuable contributions to the field of clinical pain research and (2) offer a range of opportunities for mentees to participate in clinical pain research. The overall goal of this administrative supplement is to provide mentoring and research opportunities for Dr. Sonia Sharma to contribute to the goal of increasing the number of skilled clinical pain researchers who can design, conduct, analyze, and transparently disseminate results of high-quality pain clinical trials, and in turn accelerate the development of novel therapies for chronic pain. Aim 1 will leverage the UR-EPPIC-Net clinical trials to train Dr. Sharma on the necessary skills to conduct high-quality clinical trials for chronic pain therapies. Aim 2 is a research project focused on developing novel outcomes for use in clinical trials of neurogenic intermittent claudication (NIC), a phenotypically-distinct chronic low back pain syndrome. Specifically, aim 2 will evaluate the content and construct validity of clinically- relevant, accelerometry-based outcomes for NIC. The proposed research activities will provide Dr. Sharma with the practical experiences necessary to conduct high-quality randomized clinical trials of chronic pain treatments, conduct analyses related to novel outcome development, and obtain preliminary data and publications to support applications for independent research funding.

项目摘要 /摘要 慢性疼痛影响20-30％的美国成年人。不幸的是，目前可用的疼痛治疗往往只是 适度有效，有很多人为他们提供任何救济或无法提供任何救济 容忍其不良副作用。尝试用阿片类镇痛药治疗慢性疼痛的尝试，至少在 一部分，对于当前的阿片类药物危机，影响痛苦的人以及他们的家人和朋友， 强调需要开发新颖的非成瘾性镇痛药。 NIH回应了这一需求 通过强调融合新生物标志物和的高质量镇痛临床试验的重要性 终点是为了促进有效的镇痛学的发展。为了推动这项工作，NIH建立了 早期疼痛调查临床网络（EPPIC-NET），可提供健壮且易于访问 II期临床试验快速设计和性能的基础设施。此应用程序的PI是 罗切斯特大学Eppic Net，专业临床研究中心（UR-Eppic-NET），提供了独特的 有机会培训Mentores进行多站点镇痛临床试验的进行。此外，PI正在进行的计划 研究解决了对镇痛临床试验中新型结果测量的需求，并与 EPPIC网络为（1）为临床疼痛研究领域做出宝贵的贡献，（2）提供了一系列 Mentores参加临床疼痛研究的机会。这种行政的总体目标 补充是为Sonia Sharma博士提供心理和研究机会 增加可以设计，进行，分析和透明的熟练临床疼痛研究人员的数量 传播高质量疼痛临床试验的结果，进而加速了新型疗法的发展 慢性疼痛。 AIM 1将利用UR-Eppic-NET临床试验来培训Sharma博士的必要技能 进行慢性疼痛疗法的高质量临床试验。 AIM 2是一个专注于开发的研究项目 用于神经源性间歇性laurauration（NIC）的临床试验中的新型结果，这是一种表型差异 慢性下腰痛综合征。具体而言，AIM 2将评估临床上的内容和构造有效性 NIC的相关，基于加速度计的结果。拟议的研究活动将为Sharma博士提供 进行慢性疼痛治疗的高质量随机临床试验所需的实际经验， 进行与新的结果发展有关的分析，并获得初步数据和出版物以支持 独立研究资金的申请。