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.
An Oregon site for the Network of Excellence in Neurosciences Clinical Trials will have direct clinical relevance by promoting the conduct of clinical research aimed ultimately at clinical practice. An Oregon site will be able to make substantial contributions in terms of patients enrolled and clinical neuroscience expertise brought to the Network, adhering closely to the relevant goals outlined in the RFA.
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