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.

项目总结/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有 中度有效，有许多人的治疗不提供任何救济或谁不能 忍受它们的副作用。尝试用阿片类镇痛药治疗慢性疼痛，至少在 部分原因是目前的阿片类药物危机，影响到疼痛的个人及其家人和朋友， 突出了开发新型非成瘾性镇痛剂的需要。国家卫生研究院回应了这一需求 通过强调高质量镇痛临床试验的重要性，包括新的生物标志物， 终点，以促进有效镇痛药的开发。为了推动这一努力，NIH建立了 早期疼痛研究临床网络（EPPIC-Net）提供了一个强大的，易于访问的 快速设计和执行II期临床试验的基础设施。此应用程序的PI是以下的MPI： 罗切斯特大学EPPIC网络，专业临床研究中心（UR-EPPIC-Net），提供了一个独特的 培训学员进行多中心镇痛药临床试验的机会。此外，PI正在进行的项目 的研究解决了镇痛临床试验中新的结局指标的需求，并与 EPPIC网络努力（1）为临床疼痛研究领域做出宝贵贡献，（2）提供一系列 学员参与临床疼痛研究的机会。本行政区划的总体目标 补充是为索尼娅·夏尔马博士提供指导和研究机会，为实现以下目标做出贡献 增加熟练的临床疼痛研究人员的数量，他们可以设计，进行，分析，并透明地 传播高质量疼痛临床试验的结果，从而加速新疗法的开发 治疗慢性疼痛Aim 1将利用UR-EPPIC-Net临床试验对Sharma博士进行必要的技能培训 进行高质量的慢性疼痛治疗临床试验。目标2是一个研究项目， 用于神经源性间歇性跛行（NIC）临床试验的新结果， 慢性腰痛综合征具体而言，目标2将评估临床- NIC的相关、基于加速度测量的结果。拟议的研究活动将为夏尔马博士提供 进行高质量的慢性疼痛治疗随机临床试验所需的实践经验， 进行与新结局开发相关的分析，并获得初步数据和出版物，以支持 申请独立研究经费。