Comprehensive Oregon Neuroscience Network for Excellence in Clinical Trials

描述(由申请者提供)：本建议是应NINDS神经科学临床试验卓越网络的申请而提出的。本文总结了俄勒冈健康与科学大学(OHSU)网站实现RFA具体目标的能力：1)为OHSU神经科学临床试验和研究的战略支持提供领导：领导将由SITE PI和一个代表每个神经学子专业的执行委员会提供。2)与其他临床站点、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)为临床试验提供足够数量的常见病和罕见病患者：参与的研究人员正在积极招募常见病患者参加临床试验，NEXT资金将支持开发一个数据库，以识别不常见的疾病，以便在试验开始时快速招募。4)利用当地的临床研究资源：大学行政部门、神经科和OHSU CTSA都在投入资源支持和补充下一个临床站点。5)提高OHSU临床研究企业的效率：OHSU IRB已同意建立二级中央IRB，并考虑到一级加班，OHSU临床试验办公室承诺进行多项创新，以提高临床试验的效率。6)监测临床试验表现：OHSU NEXT站点的协调员将持续监测临床试验效率和表现，并由执行委员会每月审查数据。必要时，执行委员会将指导纠正行动。7)在神经科学临床试验的设计和实施方面培训新的调查人员：这将是执行委员会每个成员的期望，以既定的记录为基础。

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.