Comprehensive Oregon Neuroscience Network for Excellence in Clinical Trials

描述（由申请人提供）：本提案是对NINDS神经科学临床试验卓越网络申请请求的回应。本摘要总结了俄勒冈州健康与科学大学（OHSU）研究中心实现RFA特定目标的能力：1）为OHSU神经科学临床试验和研究的战略支持提供领导：将由研究中心PI和代表每个神经学子专业的执行委员会提供领导。 2)与其他临床研究中心、协调中心、NINDS及其合作伙伴合作：执行委员会成员已建立跟踪记录，并致力于继续合作。 3)为开展临床试验提供足够数量的常见和罕见神经系统疾病患者：参与研究者正在积极招募临床试验中常见疾病患者，NEXT资金将支持开发用于识别不常见疾病的数据库，以促进试验启动时的快速招募。 4)为了利用当地的临床研究资源：大学管理部门，神经病学部门和OHSU CTSA都致力于支持和补充NEXT临床研究中心。 5)为了提高OHSU临床研究企业的效率：OHSU IRB已同意建立二级中心IRB，并考虑到一级加班，OHSU临床试验办公室已承诺进行多项创新以提高临床试验的效率。 6)监测临床试验绩效：OHSU NEXT研究中心的协调员将持续监测临床试验效率和绩效，执行委员会每月进行数据审查。执行委员会将根据需要指导纠正措施。 7)培训新的研究人员设计和进行神经科学临床试验：这将是执行委员会每个成员的期望，建立在既定的跟踪记录基础上。

DESCRIPTION (provided by applicant): This proposal is in response to a Request of Applications for the NINDS Network of Excellence in Neurosciences Clinical Trials. This abstract summarizes the capability of an Oregon Health and Sciences University (OHSU) site to accomplish the specific aims of the RFA: 1) To provide leadership for strategic support of neuroscience clinical trials and research at OHSU: Leadership will be provided by the site PI and an executive committee representing each of the neurologic sub-specialties. 2) To collaborate with other clinical sites, the coordinating center, NINDS and its partners: The members of the executive committee have established track records and are committed to continued collaboration. 3) To provide access to sufficient numbers of patients with both common and rare neurologic diseases for the conduct of clinical trials: Participating investigators are actively enrolling patients with common diseases in clinical trials, and NEXT funding will support the development of a database for identifying less common diseases to facilitate rapid enrollment when trials are initiated. 4) To leverage local clinical research resources: The University administration, the Neurology department, and the OHSU CTSA are all committing resources to support and complement a NEXT clinical site. 5) To increase the efficiency of the clinical research enterprise at OHSU: The OHSU IRB has agreed to a Tier 2 central IRB with consideration of Tier 1 overtime, and the OHSU Clinical Trials Office has committed to a number of innovations to improve efficiency in clinical trials. 6) To monitor clinical trial performance: The coordinator for an OHSU NEXT site will monitor clinical trial efficiency and performance on a continuing basis, with data review by the executive committee on a monthly basis. Corrective action will be directed by the executive committee as needed. 7) To train new investigators in the design and conduct of clinical trials in the neurosciences: This will be an expectation from each of the members of the Executive committee, building on established track records.