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

项目摘要/摘要 慢性疼痛影响着20%-30%的美国成年人。不幸的是，目前可用的疼痛治疗方法往往只有 中等有效，有许多人的治疗没有提供任何缓解或谁不能 容忍他们的不良副作用。用阿片类镇痛剂治疗慢性疼痛的尝试至少在 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， 强调需要开发新的、非成瘾的止痛药。美国国立卫生研究院回应了这一需求 通过强调高质量的止痛临床试验的重要性，这些试验结合了新的生物标志物和 目的是为了促进有效止痛药的开发。为了推动这一努力，美国国立卫生研究院建立了 早期疼痛调查临床网络(EPPIC-Net)提供了一个强大且易于访问的 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是的MPI 罗切斯特大学EPPIC-Net专门临床研究中心(UR-EPPIC-Net)，提供独特的 培训学员进行多部位止痛临床试验的机会。此外，PI正在进行的计划 的研究解决了在止痛临床试验中对新的结果测量的需求，并与 EPPIC-Net努力(1)为临床疼痛研究领域做出有价值的贡献，(2)提供一系列 为学员提供参与临床疼痛研究的机会。这项管理的总体目标是 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、实施、分析和透明地 传播高质量的疼痛临床试验结果，进而加速新疗法的开发 治疗慢性疼痛。Aim 1将利用UR-EPPIC-Net临床试验来培训Sharma博士必要的技能 开展高质量的慢性疼痛治疗临床试验。Aim 2是一个专注于开发 用于神经源性间歇性跛行(NIC)临床试验的新结果，这是一种独特的表型 慢性腰背痛综合征。具体地说，目标2将评估临床- NIC基于加速度计的相关结果。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， 进行与新成果开发相关的分析，并获得初步数据和出版物以支持 申请独立研究经费。

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.